Tara Haelle

The Lancet Group’s 18 medical journals have committed to ensuring that their editorial advisory boards include at least 50% female members by the end of 2019 as just one component of the diversity and gender parity initiative unveiled Aug. 8.

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“The case for gender equity and diversity is clear: Teams that are diverse in terms of gender, ethnicity, and social background produce better health science, are more highly cited, generate a broader range of ideas and innovations, and better represent society,” group editors wrote in their comment (Lancet. 2019 Aug 10;394:452-3). They emphasized the importance of increasing inclusion in science “across gender, ethnicity, geography, and other social categories.”

The Diversity Pledge states the group’s commitment “to increasing diversity and inclusion in research and publishing, and in particular to increasing the representation of women and colleagues from low-income and middle-income countries among our editorial advisers, peer reviewers, and authors.”

The No All-Male Panel Policy echoes a call from the National Institutes of Health for ending the “Manel Tradition,” as NIH Director Francis S. Collins, MD, PhD, wrote in early June. Recognizing the need “to combat cultural forces that tolerate gender harassment and limit the advancement of women,” Dr. Collins pledged to decline speaking invitations if “attention to inclusiveness” is not clear in the event’s agenda.

Discussion of “manels” – all-male panels – and the decision to boycott them has been picking up speed in scientific, medical and even business circles over the past several years. The BBC highlighted a popular blog that shamed events with all-male panels in 2015, and a 2018 study more formally concluded that male scientists had considerably more opportunities to speak and present at the world’s largest geophysical conference.

One business and development leader even included space on his website to allow other leaders to pledge not to “serve on a panel of two people or more unless there is at least one woman on the panel, not including the chair.” More than 2,000 leaders from across the globe already have signed.

Six months ago, the Lancet published a special theme issue on women in science, medicine, and global health. The editors noted in the issue that women comprise fewer than a third of authors and reviewers in high-impact medical journals – just one example of the underrepresentation of women and people in color in medical publishing. The group is now revamping their systems to address the disparities.

“An upcoming update of our online submission system will have a field for self-selected gender, so we can better track representation across genders among authors, reviewers, editors, and editorial advisers, along with country of origin,” the editors wrote.

But they acknowledged that their efforts are just one piece of the academic ecosystem and called on others’ participation. “We encourage other publishers, journals, and members of the science community to contribute to these pledges.”

SOURCE: Lancet. 2019 Aug 10;394:452-3.

The Lancet Group’s 18 medical journals have committed to ensuring that their editorial advisory boards include at least 50% female members by the end of 2019 as just one component of the diversity and gender parity initiative unveiled Aug. 8.

webphotographeer/Getty Images

“The case for gender equity and diversity is clear: Teams that are diverse in terms of gender, ethnicity, and social background produce better health science, are more highly cited, generate a broader range of ideas and innovations, and better represent society,” group editors wrote in their comment (Lancet. 2019 Aug 10;394:452-3). They emphasized the importance of increasing inclusion in science “across gender, ethnicity, geography, and other social categories.”

The Diversity Pledge states the group’s commitment “to increasing diversity and inclusion in research and publishing, and in particular to increasing the representation of women and colleagues from low-income and middle-income countries among our editorial advisers, peer reviewers, and authors.”

The No All-Male Panel Policy echoes a call from the National Institutes of Health for ending the “Manel Tradition,” as NIH Director Francis S. Collins, MD, PhD, wrote in early June. Recognizing the need “to combat cultural forces that tolerate gender harassment and limit the advancement of women,” Dr. Collins pledged to decline speaking invitations if “attention to inclusiveness” is not clear in the event’s agenda.

Discussion of “manels” – all-male panels – and the decision to boycott them has been picking up speed in scientific, medical and even business circles over the past several years. The BBC highlighted a popular blog that shamed events with all-male panels in 2015, and a 2018 study more formally concluded that male scientists had considerably more opportunities to speak and present at the world’s largest geophysical conference.

One business and development leader even included space on his website to allow other leaders to pledge not to “serve on a panel of two people or more unless there is at least one woman on the panel, not including the chair.” More than 2,000 leaders from across the globe already have signed.

Six months ago, the Lancet published a special theme issue on women in science, medicine, and global health. The editors noted in the issue that women comprise fewer than a third of authors and reviewers in high-impact medical journals – just one example of the underrepresentation of women and people in color in medical publishing. The group is now revamping their systems to address the disparities.

“An upcoming update of our online submission system will have a field for self-selected gender, so we can better track representation across genders among authors, reviewers, editors, and editorial advisers, along with country of origin,” the editors wrote.

But they acknowledged that their efforts are just one piece of the academic ecosystem and called on others’ participation. “We encourage other publishers, journals, and members of the science community to contribute to these pledges.”

SOURCE: Lancet. 2019 Aug 10;394:452-3.

The Lancet Group’s 18 medical journals have committed to ensuring that their editorial advisory boards include at least 50% female members by the end of 2019 as just one component of the diversity and gender parity initiative unveiled Aug. 8.

webphotographeer/Getty Images

“The case for gender equity and diversity is clear: Teams that are diverse in terms of gender, ethnicity, and social background produce better health science, are more highly cited, generate a broader range of ideas and innovations, and better represent society,” group editors wrote in their comment (Lancet. 2019 Aug 10;394:452-3). They emphasized the importance of increasing inclusion in science “across gender, ethnicity, geography, and other social categories.”

The Diversity Pledge states the group’s commitment “to increasing diversity and inclusion in research and publishing, and in particular to increasing the representation of women and colleagues from low-income and middle-income countries among our editorial advisers, peer reviewers, and authors.”

The No All-Male Panel Policy echoes a call from the National Institutes of Health for ending the “Manel Tradition,” as NIH Director Francis S. Collins, MD, PhD, wrote in early June. Recognizing the need “to combat cultural forces that tolerate gender harassment and limit the advancement of women,” Dr. Collins pledged to decline speaking invitations if “attention to inclusiveness” is not clear in the event’s agenda.

Discussion of “manels” – all-male panels – and the decision to boycott them has been picking up speed in scientific, medical and even business circles over the past several years. The BBC highlighted a popular blog that shamed events with all-male panels in 2015, and a 2018 study more formally concluded that male scientists had considerably more opportunities to speak and present at the world’s largest geophysical conference.

One business and development leader even included space on his website to allow other leaders to pledge not to “serve on a panel of two people or more unless there is at least one woman on the panel, not including the chair.” More than 2,000 leaders from across the globe already have signed.

Six months ago, the Lancet published a special theme issue on women in science, medicine, and global health. The editors noted in the issue that women comprise fewer than a third of authors and reviewers in high-impact medical journals – just one example of the underrepresentation of women and people in color in medical publishing. The group is now revamping their systems to address the disparities.

“An upcoming update of our online submission system will have a field for self-selected gender, so we can better track representation across genders among authors, reviewers, editors, and editorial advisers, along with country of origin,” the editors wrote.

But they acknowledged that their efforts are just one piece of the academic ecosystem and called on others’ participation. “We encourage other publishers, journals, and members of the science community to contribute to these pledges.”

SOURCE: Lancet. 2019 Aug 10;394:452-3.

Development of an effective respiratory syncytial virus (RSV) vaccine is feasible using a new technology that can contribute to development of other vaccines as well, according to results of a proof-of-concept study in Science.

Micah Young/istockphoto.com

The new method of protein engineering preserves the RSV antigen protein’s prefusion structure, including the epitope, thereby inducing antibodies that better “match,” and neutralize, the actual pathogen.

“Protein-based RSV vaccines have had a particularly complicated history, especially those in which the primary immunogen has been the fusion (F) glycoprotein, which exists in two major conformational states: prefusion (pre-F) and postfusion (post-F),” lead author Michelle Crank, MD, of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, Md., and her colleagues explained in the paper.

Since the failure of the whole-inactivated RSV vaccine in the 1960s, researchers have focused on F subunit vaccine candidates, but these contain only post-F or “structurally undefined” F protein.

“Although the products are immunogenic, a substantial proportion of antibodies elicited are non- or poorly neutralizing, and field trials have shown no or minimal efficacy,” the authors wrote.

But now researchers have an “atomic-level understanding of F conformational states, antigenic sites, and the specificity of the human B cell repertoire and serum antibody response to infection.” Having developed a way to engineer proteins to retain the F protein’s prefusion conformation, the researchers developed the DS-Cav1 vaccine with an F protein from RSV subtype A.

In their phase 1, randomized, open-label clinical trial, the researchers tested the safety, tolerability and immunogenicity of DS-Cav1. The trial involved 90 healthy adults, aged 18-50, who had no abnormal findings in clinical lab tests, their medical history, or a physical exam.

The participants received two intramuscular doses, 12 weeks apart, of either 50 mcg, 150 mcg or 500 mcg of the vaccine. In each of these dosage groups, half the participants received a vaccine with 0.5 mcg of alum as an adjuvant, and half received a vaccine without any adjuvants. Each of the six randomized dosage-adjuvant groups had 15 participants.

The investigators report on safety and immunogenicity through 28 days after the first vaccine dose among the first 40 participants enrolled, each randomly assigned into four groups of 10 for the 50 mcg and 150 mcg doses with and without the adjuvant. Their primary immunogenicity endpoint was neutralizing activity from the vaccine.

Neutralizing activity with RSV A was seven times higher with 50 mcg and 12-15 times higher with 150 mcg at week 4 than at baseline (P less than .001).

“These increases in neutralizing activity were higher than those previously reported for F protein subunit vaccines and exceeded the threefold increase in neutralization reported after experimental human challenge with RSV,” the authors noted. Neutralization levels remained 5-10 times higher than baseline at week 12 (P less than .001).

Even with RSV B, neutralizing activity from DS-Cav1 was 4-6 times greater with 50 mcg and 9 times greater with 150 mcg, both with and without alum (P less than .001).

“The boost in neutralizing activity to subtype B after a single immunization with a subtype A–based F vaccine reflected the high conservation of F between subtypes and suggested that multiple prior infections by both RSV A and B subtypes establishes a broad preexisting B-cell repertoire,” the authors wrote.

The adjuvant had no clinically significant effect on immunogenicity, and no serious adverse events occurred in the groups.

The findings reveal that DS-Cav1 induces antibodies far more functionally effective than seen in previous RSV vaccines while opening the door to using similar techniques with other vaccines, the authors wrote. “We are now entering an era of vaccinology in which new technologies provide avenues to define the structural basis of antigenicity and to rapidly isolate and characterize human monoclonal antibodies,” the researchers wrote, marking “a step toward a future of precision vaccines.”

The research was funded by the National Institutes of Health and the Bill & Melinda Gates Foundation. Several of the study authors are inventors on patents for stabilizing the RSV F protein.

SOURCE: Crank MC et al. Science. 2019; 365(6452):505-9.

Development of an effective respiratory syncytial virus (RSV) vaccine is feasible using a new technology that can contribute to development of other vaccines as well, according to results of a proof-of-concept study in Science.

Micah Young/istockphoto.com

The new method of protein engineering preserves the RSV antigen protein’s prefusion structure, including the epitope, thereby inducing antibodies that better “match,” and neutralize, the actual pathogen.

“Protein-based RSV vaccines have had a particularly complicated history, especially those in which the primary immunogen has been the fusion (F) glycoprotein, which exists in two major conformational states: prefusion (pre-F) and postfusion (post-F),” lead author Michelle Crank, MD, of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, Md., and her colleagues explained in the paper.

Since the failure of the whole-inactivated RSV vaccine in the 1960s, researchers have focused on F subunit vaccine candidates, but these contain only post-F or “structurally undefined” F protein.

“Although the products are immunogenic, a substantial proportion of antibodies elicited are non- or poorly neutralizing, and field trials have shown no or minimal efficacy,” the authors wrote.

But now researchers have an “atomic-level understanding of F conformational states, antigenic sites, and the specificity of the human B cell repertoire and serum antibody response to infection.” Having developed a way to engineer proteins to retain the F protein’s prefusion conformation, the researchers developed the DS-Cav1 vaccine with an F protein from RSV subtype A.

In their phase 1, randomized, open-label clinical trial, the researchers tested the safety, tolerability and immunogenicity of DS-Cav1. The trial involved 90 healthy adults, aged 18-50, who had no abnormal findings in clinical lab tests, their medical history, or a physical exam.

The participants received two intramuscular doses, 12 weeks apart, of either 50 mcg, 150 mcg or 500 mcg of the vaccine. In each of these dosage groups, half the participants received a vaccine with 0.5 mcg of alum as an adjuvant, and half received a vaccine without any adjuvants. Each of the six randomized dosage-adjuvant groups had 15 participants.

The investigators report on safety and immunogenicity through 28 days after the first vaccine dose among the first 40 participants enrolled, each randomly assigned into four groups of 10 for the 50 mcg and 150 mcg doses with and without the adjuvant. Their primary immunogenicity endpoint was neutralizing activity from the vaccine.

Neutralizing activity with RSV A was seven times higher with 50 mcg and 12-15 times higher with 150 mcg at week 4 than at baseline (P less than .001).

“These increases in neutralizing activity were higher than those previously reported for F protein subunit vaccines and exceeded the threefold increase in neutralization reported after experimental human challenge with RSV,” the authors noted. Neutralization levels remained 5-10 times higher than baseline at week 12 (P less than .001).

Even with RSV B, neutralizing activity from DS-Cav1 was 4-6 times greater with 50 mcg and 9 times greater with 150 mcg, both with and without alum (P less than .001).

“The boost in neutralizing activity to subtype B after a single immunization with a subtype A–based F vaccine reflected the high conservation of F between subtypes and suggested that multiple prior infections by both RSV A and B subtypes establishes a broad preexisting B-cell repertoire,” the authors wrote.

The adjuvant had no clinically significant effect on immunogenicity, and no serious adverse events occurred in the groups.

The findings reveal that DS-Cav1 induces antibodies far more functionally effective than seen in previous RSV vaccines while opening the door to using similar techniques with other vaccines, the authors wrote. “We are now entering an era of vaccinology in which new technologies provide avenues to define the structural basis of antigenicity and to rapidly isolate and characterize human monoclonal antibodies,” the researchers wrote, marking “a step toward a future of precision vaccines.”

The research was funded by the National Institutes of Health and the Bill & Melinda Gates Foundation. Several of the study authors are inventors on patents for stabilizing the RSV F protein.

SOURCE: Crank MC et al. Science. 2019; 365(6452):505-9.

Development of an effective respiratory syncytial virus (RSV) vaccine is feasible using a new technology that can contribute to development of other vaccines as well, according to results of a proof-of-concept study in Science.

Micah Young/istockphoto.com

The new method of protein engineering preserves the RSV antigen protein’s prefusion structure, including the epitope, thereby inducing antibodies that better “match,” and neutralize, the actual pathogen.

“Protein-based RSV vaccines have had a particularly complicated history, especially those in which the primary immunogen has been the fusion (F) glycoprotein, which exists in two major conformational states: prefusion (pre-F) and postfusion (post-F),” lead author Michelle Crank, MD, of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, Md., and her colleagues explained in the paper.

Since the failure of the whole-inactivated RSV vaccine in the 1960s, researchers have focused on F subunit vaccine candidates, but these contain only post-F or “structurally undefined” F protein.

“Although the products are immunogenic, a substantial proportion of antibodies elicited are non- or poorly neutralizing, and field trials have shown no or minimal efficacy,” the authors wrote.

But now researchers have an “atomic-level understanding of F conformational states, antigenic sites, and the specificity of the human B cell repertoire and serum antibody response to infection.” Having developed a way to engineer proteins to retain the F protein’s prefusion conformation, the researchers developed the DS-Cav1 vaccine with an F protein from RSV subtype A.

In their phase 1, randomized, open-label clinical trial, the researchers tested the safety, tolerability and immunogenicity of DS-Cav1. The trial involved 90 healthy adults, aged 18-50, who had no abnormal findings in clinical lab tests, their medical history, or a physical exam.

The participants received two intramuscular doses, 12 weeks apart, of either 50 mcg, 150 mcg or 500 mcg of the vaccine. In each of these dosage groups, half the participants received a vaccine with 0.5 mcg of alum as an adjuvant, and half received a vaccine without any adjuvants. Each of the six randomized dosage-adjuvant groups had 15 participants.

The investigators report on safety and immunogenicity through 28 days after the first vaccine dose among the first 40 participants enrolled, each randomly assigned into four groups of 10 for the 50 mcg and 150 mcg doses with and without the adjuvant. Their primary immunogenicity endpoint was neutralizing activity from the vaccine.

Neutralizing activity with RSV A was seven times higher with 50 mcg and 12-15 times higher with 150 mcg at week 4 than at baseline (P less than .001).

“These increases in neutralizing activity were higher than those previously reported for F protein subunit vaccines and exceeded the threefold increase in neutralization reported after experimental human challenge with RSV,” the authors noted. Neutralization levels remained 5-10 times higher than baseline at week 12 (P less than .001).

Even with RSV B, neutralizing activity from DS-Cav1 was 4-6 times greater with 50 mcg and 9 times greater with 150 mcg, both with and without alum (P less than .001).

“The boost in neutralizing activity to subtype B after a single immunization with a subtype A–based F vaccine reflected the high conservation of F between subtypes and suggested that multiple prior infections by both RSV A and B subtypes establishes a broad preexisting B-cell repertoire,” the authors wrote.

The adjuvant had no clinically significant effect on immunogenicity, and no serious adverse events occurred in the groups.

The findings reveal that DS-Cav1 induces antibodies far more functionally effective than seen in previous RSV vaccines while opening the door to using similar techniques with other vaccines, the authors wrote. “We are now entering an era of vaccinology in which new technologies provide avenues to define the structural basis of antigenicity and to rapidly isolate and characterize human monoclonal antibodies,” the researchers wrote, marking “a step toward a future of precision vaccines.”

The research was funded by the National Institutes of Health and the Bill & Melinda Gates Foundation. Several of the study authors are inventors on patents for stabilizing the RSV F protein.

SOURCE: Crank MC et al. Science. 2019; 365(6452):505-9.

Cryopreserving semen is a feasible option for preserving the fertility of adolescents and young adults who were assigned male at birth and are beginning or have already begun gender-affirming treatment as transgender women, according to results of a small retrospective cohort study.

The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.

“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.

The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.

The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.

All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.

The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.

All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.

One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).

Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.

“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.

For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.

SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.

Cryopreserving semen is a feasible option for preserving the fertility of adolescents and young adults who were assigned male at birth and are beginning or have already begun gender-affirming treatment as transgender women, according to results of a small retrospective cohort study.

The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.

“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.

The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.

The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.

All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.

The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.

All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.

One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).

Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.

“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.

For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.

SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.

Cryopreserving semen is a feasible option for preserving the fertility of adolescents and young adults who were assigned male at birth and are beginning or have already begun gender-affirming treatment as transgender women, according to results of a small retrospective cohort study.

The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.

“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.

The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.

The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.

All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.

The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.

All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.

One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).

Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.

“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.

For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.

SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.

SAN ANTONIO – Most attention paid to barriers for medication-assisted treatment of opioid use disorder has focused on prescribers and patients, but pharmacists are “a neglected link in the chain,” according to Hannah Cooper, ScD, an assistant professor of behavioral sciences and health education at Emory University, Atlanta.

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“Pharmacy-based dispensing of buprenorphine is one of the medication’s major advances over methadone,” Dr. Cooper told attendees at the annual meeting of the College on Problems of Drug Dependence. Yet, early interviews she and her colleagues conducted with rural Kentucky pharmacist colleagues in the CARE2HOPE study “revealed that pharmacy-level barriers might also curtail access to buprenorphine.”

Little research has examined those barriers, but one past survey of pharmacists in West Virginia found that half did not stock buprenorphine, Dr. Cooper noted. Further, anecdotal evidence has suggested that wholesaler concerns about Drug Enforcement Administration restrictions on dispensing buprenorphine has caused shortages at pharmacies.

Dr. Cooper and colleagues, therefore, designed a qualitative study aimed at learning about pharmacists’ attitudes and dispensing practices related to buprenorphine. They also looked at whether DEA limits actually exist on dispensing the drug. They interviewed 14 pharmacists operating 15 pharmacies across all 12 counties in two rural Kentucky health districts. Eleven of the pharmacists worked in independent pharmacies; the others worked at chains. Six pharmacies dispensed more than 100 buprenorphine prescriptions a month, five dispensed only several dozen a month, and four refused to dispense it at all.

Perceptions of federal restrictions

“Variations in buprenorphine dispensing did not solely reflect underlying variations in local need or prescribing practices,” Dr. Cooper said. At 12 of the 15 pharmacies, limits on buprenorphine resulted from a perceived DEA “cap” on dispensing the drug or “because of distrust in buprenorphine itself, its prescribers and its patients.”

The perceived cap from the DEA was shrouded in uncertainty: 10 of the pharmacists said the DEA capped the percentage of controlled substances pharmacists could dispense that were opioids, yet the pharmacists did not know what that percentage was.

Five of those interviewed said the cap often significantly cut short how many buprenorphine prescriptions they would dispense. Since they did not know how much the cap was, they internally set arbitrary limits, such as dispensing two prescriptions per day, to avoid risk of the DEA investigating their pharmacy.

Yet, those limits could not meet patient demand, so several pharmacists rationed buprenorphine only to local residents or long-term customers, causing additional problems. That practice strained relationships with prescribers, who then had to call multiple pharmacies to find one that would dispense the drug to new patients. It also put pharmacy staff at risk when a rejection angered a customer and “undermined local recovery efforts,” Dr. Cooper said.

Five other pharmacists, however, did not ration their buprenorphine and did not worry about exceeding the DEA cap.

No numerical cap appears to exist, but DEA regulations and the SUPPORT for Patients and Communities Act do require internal opioid surveillance systems at wholesalers that flag suspicious orders of controlled substances, including buprenorphine. And they enforce it: An $80 million settlement in 2013 resulted from the DEA’s charge that Walgreens distribution centers did not report suspicious drug orders.

Stigma among some pharmacists

Six of the pharmacists had low trust in buprenorphine and in those who prescribed it and used it, Dr. Cooper reported. Three would not dispense the drug at all, and two would not take new buprenorphine patients.

One such pharmacist told researchers: “It is supposed to be the drug to help them [recover.] They want Suboxone worse than they do the hydrocodone. … It’s not what it’s designed to be.”

Those pharmacists also reported believing that malpractice was common among prescribers, who, for example, did not provide required counseling to patients or did not quickly wean them off buprenorphine. The pharmacists perceived the physicians prescribing buprenorphine as doing so only to make more money, just as they had done by prescribing opioids in the first place.

Those pharmacists also believed the patients themselves sold buprenorphine to make money and that opioid use disorder was a choice. They told researchers that dispensing buprenorphine would bring more drug users to their stores and subsequently hurt business.

Yet, those beliefs were not universal among the pharmacists. Eight believed buprenorphine was an appropriate opioid use disorder treatment and had positive attitudes toward patients. Unlike those who viewed the disorder as a choice, those pharmacists saw it as a disease and viewed the patients admirably for their commitment to recovery.

Though a small, qualitative study, those findings suggest a need to more closely examine how pharmacies affect access to medication to treat opioid use disorder, Dr. Cooper said.

“In an epicenter of the U.S. opioid epidemic, policies and stigma curtail access to buprenorphine,” she told attendees. “DEA regulations, the SUPPORT Act, and related lawsuits have led wholesalers to develop proprietary caps that force some pharmacists to ration the number of buprenorphine prescriptions they filled.” Some pharmacists will not dispense the drug at all, while others “limited dispensing to known or local patients and prescribers, a practice that pharmacists recognized hurt patients who had to travel far to reach prescribers.”

The research was funded by the National Institutes of Health through CARE2HOPE, Rural Health Project, and the Emory Center for AIDS Research. The authors reported no disclosures.

SAN ANTONIO – Most attention paid to barriers for medication-assisted treatment of opioid use disorder has focused on prescribers and patients, but pharmacists are “a neglected link in the chain,” according to Hannah Cooper, ScD, an assistant professor of behavioral sciences and health education at Emory University, Atlanta.

StockPlanets/Getty Images

“Pharmacy-based dispensing of buprenorphine is one of the medication’s major advances over methadone,” Dr. Cooper told attendees at the annual meeting of the College on Problems of Drug Dependence. Yet, early interviews she and her colleagues conducted with rural Kentucky pharmacist colleagues in the CARE2HOPE study “revealed that pharmacy-level barriers might also curtail access to buprenorphine.”

Little research has examined those barriers, but one past survey of pharmacists in West Virginia found that half did not stock buprenorphine, Dr. Cooper noted. Further, anecdotal evidence has suggested that wholesaler concerns about Drug Enforcement Administration restrictions on dispensing buprenorphine has caused shortages at pharmacies.

Dr. Cooper and colleagues, therefore, designed a qualitative study aimed at learning about pharmacists’ attitudes and dispensing practices related to buprenorphine. They also looked at whether DEA limits actually exist on dispensing the drug. They interviewed 14 pharmacists operating 15 pharmacies across all 12 counties in two rural Kentucky health districts. Eleven of the pharmacists worked in independent pharmacies; the others worked at chains. Six pharmacies dispensed more than 100 buprenorphine prescriptions a month, five dispensed only several dozen a month, and four refused to dispense it at all.

Perceptions of federal restrictions

“Variations in buprenorphine dispensing did not solely reflect underlying variations in local need or prescribing practices,” Dr. Cooper said. At 12 of the 15 pharmacies, limits on buprenorphine resulted from a perceived DEA “cap” on dispensing the drug or “because of distrust in buprenorphine itself, its prescribers and its patients.”

The perceived cap from the DEA was shrouded in uncertainty: 10 of the pharmacists said the DEA capped the percentage of controlled substances pharmacists could dispense that were opioids, yet the pharmacists did not know what that percentage was.

Five of those interviewed said the cap often significantly cut short how many buprenorphine prescriptions they would dispense. Since they did not know how much the cap was, they internally set arbitrary limits, such as dispensing two prescriptions per day, to avoid risk of the DEA investigating their pharmacy.

Yet, those limits could not meet patient demand, so several pharmacists rationed buprenorphine only to local residents or long-term customers, causing additional problems. That practice strained relationships with prescribers, who then had to call multiple pharmacies to find one that would dispense the drug to new patients. It also put pharmacy staff at risk when a rejection angered a customer and “undermined local recovery efforts,” Dr. Cooper said.

Five other pharmacists, however, did not ration their buprenorphine and did not worry about exceeding the DEA cap.

No numerical cap appears to exist, but DEA regulations and the SUPPORT for Patients and Communities Act do require internal opioid surveillance systems at wholesalers that flag suspicious orders of controlled substances, including buprenorphine. And they enforce it: An $80 million settlement in 2013 resulted from the DEA’s charge that Walgreens distribution centers did not report suspicious drug orders.

Stigma among some pharmacists

Six of the pharmacists had low trust in buprenorphine and in those who prescribed it and used it, Dr. Cooper reported. Three would not dispense the drug at all, and two would not take new buprenorphine patients.

One such pharmacist told researchers: “It is supposed to be the drug to help them [recover.] They want Suboxone worse than they do the hydrocodone. … It’s not what it’s designed to be.”

Those pharmacists also reported believing that malpractice was common among prescribers, who, for example, did not provide required counseling to patients or did not quickly wean them off buprenorphine. The pharmacists perceived the physicians prescribing buprenorphine as doing so only to make more money, just as they had done by prescribing opioids in the first place.

Those pharmacists also believed the patients themselves sold buprenorphine to make money and that opioid use disorder was a choice. They told researchers that dispensing buprenorphine would bring more drug users to their stores and subsequently hurt business.

Yet, those beliefs were not universal among the pharmacists. Eight believed buprenorphine was an appropriate opioid use disorder treatment and had positive attitudes toward patients. Unlike those who viewed the disorder as a choice, those pharmacists saw it as a disease and viewed the patients admirably for their commitment to recovery.

Though a small, qualitative study, those findings suggest a need to more closely examine how pharmacies affect access to medication to treat opioid use disorder, Dr. Cooper said.

“In an epicenter of the U.S. opioid epidemic, policies and stigma curtail access to buprenorphine,” she told attendees. “DEA regulations, the SUPPORT Act, and related lawsuits have led wholesalers to develop proprietary caps that force some pharmacists to ration the number of buprenorphine prescriptions they filled.” Some pharmacists will not dispense the drug at all, while others “limited dispensing to known or local patients and prescribers, a practice that pharmacists recognized hurt patients who had to travel far to reach prescribers.”

The research was funded by the National Institutes of Health through CARE2HOPE, Rural Health Project, and the Emory Center for AIDS Research. The authors reported no disclosures.

SAN ANTONIO – Most attention paid to barriers for medication-assisted treatment of opioid use disorder has focused on prescribers and patients, but pharmacists are “a neglected link in the chain,” according to Hannah Cooper, ScD, an assistant professor of behavioral sciences and health education at Emory University, Atlanta.

StockPlanets/Getty Images

“Pharmacy-based dispensing of buprenorphine is one of the medication’s major advances over methadone,” Dr. Cooper told attendees at the annual meeting of the College on Problems of Drug Dependence. Yet, early interviews she and her colleagues conducted with rural Kentucky pharmacist colleagues in the CARE2HOPE study “revealed that pharmacy-level barriers might also curtail access to buprenorphine.”

Little research has examined those barriers, but one past survey of pharmacists in West Virginia found that half did not stock buprenorphine, Dr. Cooper noted. Further, anecdotal evidence has suggested that wholesaler concerns about Drug Enforcement Administration restrictions on dispensing buprenorphine has caused shortages at pharmacies.

Dr. Cooper and colleagues, therefore, designed a qualitative study aimed at learning about pharmacists’ attitudes and dispensing practices related to buprenorphine. They also looked at whether DEA limits actually exist on dispensing the drug. They interviewed 14 pharmacists operating 15 pharmacies across all 12 counties in two rural Kentucky health districts. Eleven of the pharmacists worked in independent pharmacies; the others worked at chains. Six pharmacies dispensed more than 100 buprenorphine prescriptions a month, five dispensed only several dozen a month, and four refused to dispense it at all.

Perceptions of federal restrictions

“Variations in buprenorphine dispensing did not solely reflect underlying variations in local need or prescribing practices,” Dr. Cooper said. At 12 of the 15 pharmacies, limits on buprenorphine resulted from a perceived DEA “cap” on dispensing the drug or “because of distrust in buprenorphine itself, its prescribers and its patients.”

The perceived cap from the DEA was shrouded in uncertainty: 10 of the pharmacists said the DEA capped the percentage of controlled substances pharmacists could dispense that were opioids, yet the pharmacists did not know what that percentage was.

Five of those interviewed said the cap often significantly cut short how many buprenorphine prescriptions they would dispense. Since they did not know how much the cap was, they internally set arbitrary limits, such as dispensing two prescriptions per day, to avoid risk of the DEA investigating their pharmacy.

Yet, those limits could not meet patient demand, so several pharmacists rationed buprenorphine only to local residents or long-term customers, causing additional problems. That practice strained relationships with prescribers, who then had to call multiple pharmacies to find one that would dispense the drug to new patients. It also put pharmacy staff at risk when a rejection angered a customer and “undermined local recovery efforts,” Dr. Cooper said.

Five other pharmacists, however, did not ration their buprenorphine and did not worry about exceeding the DEA cap.

No numerical cap appears to exist, but DEA regulations and the SUPPORT for Patients and Communities Act do require internal opioid surveillance systems at wholesalers that flag suspicious orders of controlled substances, including buprenorphine. And they enforce it: An $80 million settlement in 2013 resulted from the DEA’s charge that Walgreens distribution centers did not report suspicious drug orders.

Stigma among some pharmacists

Six of the pharmacists had low trust in buprenorphine and in those who prescribed it and used it, Dr. Cooper reported. Three would not dispense the drug at all, and two would not take new buprenorphine patients.

One such pharmacist told researchers: “It is supposed to be the drug to help them [recover.] They want Suboxone worse than they do the hydrocodone. … It’s not what it’s designed to be.”

Those pharmacists also reported believing that malpractice was common among prescribers, who, for example, did not provide required counseling to patients or did not quickly wean them off buprenorphine. The pharmacists perceived the physicians prescribing buprenorphine as doing so only to make more money, just as they had done by prescribing opioids in the first place.

Those pharmacists also believed the patients themselves sold buprenorphine to make money and that opioid use disorder was a choice. They told researchers that dispensing buprenorphine would bring more drug users to their stores and subsequently hurt business.

Yet, those beliefs were not universal among the pharmacists. Eight believed buprenorphine was an appropriate opioid use disorder treatment and had positive attitudes toward patients. Unlike those who viewed the disorder as a choice, those pharmacists saw it as a disease and viewed the patients admirably for their commitment to recovery.

Though a small, qualitative study, those findings suggest a need to more closely examine how pharmacies affect access to medication to treat opioid use disorder, Dr. Cooper said.

“In an epicenter of the U.S. opioid epidemic, policies and stigma curtail access to buprenorphine,” she told attendees. “DEA regulations, the SUPPORT Act, and related lawsuits have led wholesalers to develop proprietary caps that force some pharmacists to ration the number of buprenorphine prescriptions they filled.” Some pharmacists will not dispense the drug at all, while others “limited dispensing to known or local patients and prescribers, a practice that pharmacists recognized hurt patients who had to travel far to reach prescribers.”

The research was funded by the National Institutes of Health through CARE2HOPE, Rural Health Project, and the Emory Center for AIDS Research. The authors reported no disclosures.

SAN ANTONIO – A mindfulness-based relapse prevention program resulted in significantly greater declines in anxiety and depressive symptoms among participants in an opioid addiction treatment program than those seen in patients who received treatment as usual, suggest results of a small nonrandomized controlled trial. Relapse rates trended downward with mindfulness but were not significantly different from the treatment-as-usual (TAU) group.

“Mindfulness-based relapse prevention (MBRP) can be successfully implemented in an outpatient setting with as good as or better results as treatment as usual,” Keith J. Zullig, PhD, MSPH, chair and professor in the department of social and behavioral sciences at the West Virginia University School of Public Health in Morgantown, said at the annual meeting of the College on Problems of Drug Dependence.

Though relapse rates did not show a statistically significant drop with mindfulness treatment compared with treatment as usual, the downward trend suggests that it is worthwhile to conduct a larger scale study, Dr. Zullig said.

The significant reductions in anxiety and depression scores among those practicing mindfulness suggest that MBRP particularly benefits patients with co-occurring mood disorders, he added.

The researchers recruited 60 participants from a Comprehensive Opioid Addiction Treatment program who had been substance free for at least 90 consecutive days. Participants chose whether to enter the MBRP group or the treatment-as-usual group.

The treatment-as-usual group attended biweekly 60-minute sessions with a cognitive-based therapy process group led by a licensed therapist for 36 weeks. The MBRP group involved 24 weeks of biweekly attendance at 60-minute sessions, also led by a licensed therapist, followed by 12 weeks in the treatment-as-usual group.

The MBRP instruction involved the following:

• Mindful skill building
• Breathing
• Meditation
• Mindful movement (“gentle yoga practiced with mindful awareness of the body”)
• Using all the senses
• Increasing awareness of breath, body sensations, thoughts, and emotional energy
• Mindfulness in everyday life
• Daily home practice of formal mindfulness meditation for 30 minutes per day, 5-6 days a week
• Discussing practice/exercises both in and outside class

Researchers tracked retention rates, any prohibited substance relapse, and four self-reported measures at 12, 24, and 36 weeks’ follow-up. The self-reported measures looked at craving, with the Desire for Drug Questionnaire; anxiety, with the Overall Anxiety Severity and Impairment Scale, range 0-20); depression, with the Overall Depression Severity and Impairment Scale, range 0-20; and mindfulness, with the Five Facet Mindfulness Questionnaire.

Participants in both groups were statistically similar in gender, employment, education, insurance, and marital status at baseline.

Of the 24 patients who entered the MBRP program, 14 completed the full 24 weeks of intervention and 12 subsequent weeks. Among the 36 participants who entered the treatment-as-usual group, 20 completed the 36 weeks.

Retention was 75% in both groups at 24 weeks, but retention from 24 to 36 weeks was nonsignificantly greater in the mindfulness group (93% vs. 91% treatment as usual).

Relapse at both 24 and 36 weeks was lower among those using mindfulness but without a statistically significant difference. At 24 weeks, 44% of the treatment-as-usual participants had relapsed at least once, compared with 33% of the MBRP participants (intent to treat).

At 36 weeks (n = 37), 45% of the 22 remaining in the treatment-as-usual group had relapsed, compared with 40% of the 15 in the MBRP group. However, 20% of those in MBRP (3 of 15) relapsed between the 24 and 36 week follow-ups, compared with 5% (1 of 22) in the treatment-as-usual group, still a nonsignificant difference.

Anxiety scores were higher at baseline in the MBRP group (11 MBRP vs. 7.25 TAU) but were similar in both groups at 36 weeks (5.79 MBRP vs. 5.6 TAU). Depression scores also were higher at baseline in the MBRP (8 vs. 6.3) but ended slightly lower than the treatment-as-usual group at 36 weeks (3.71 MBRP vs. 4.35 TAU). The reductions in depression and anxiety scores for the MBRP group were significantly greater than in the treatment-as-usual group.

Mindfulness scores were not significantly different at baseline between the groups but were significantly higher at 36 weeks in the mindfulness groups (3.47 vs. 3.3, range 1-5).

“Relapse rates were trending lower in the MBRP group although not statistically significant,” Dr. Zullig said. “Significant decreases occurred in craving in both MBRP and treatment-as-usual groups.”

The Centers for Disease Control and Prevention funded the research. The authors had no disclosures.

SAN ANTONIO – A mindfulness-based relapse prevention program resulted in significantly greater declines in anxiety and depressive symptoms among participants in an opioid addiction treatment program than those seen in patients who received treatment as usual, suggest results of a small nonrandomized controlled trial. Relapse rates trended downward with mindfulness but were not significantly different from the treatment-as-usual (TAU) group.

“Mindfulness-based relapse prevention (MBRP) can be successfully implemented in an outpatient setting with as good as or better results as treatment as usual,” Keith J. Zullig, PhD, MSPH, chair and professor in the department of social and behavioral sciences at the West Virginia University School of Public Health in Morgantown, said at the annual meeting of the College on Problems of Drug Dependence.

Though relapse rates did not show a statistically significant drop with mindfulness treatment compared with treatment as usual, the downward trend suggests that it is worthwhile to conduct a larger scale study, Dr. Zullig said.

The significant reductions in anxiety and depression scores among those practicing mindfulness suggest that MBRP particularly benefits patients with co-occurring mood disorders, he added.

The researchers recruited 60 participants from a Comprehensive Opioid Addiction Treatment program who had been substance free for at least 90 consecutive days. Participants chose whether to enter the MBRP group or the treatment-as-usual group.

The treatment-as-usual group attended biweekly 60-minute sessions with a cognitive-based therapy process group led by a licensed therapist for 36 weeks. The MBRP group involved 24 weeks of biweekly attendance at 60-minute sessions, also led by a licensed therapist, followed by 12 weeks in the treatment-as-usual group.

The MBRP instruction involved the following:

• Mindful skill building
• Breathing
• Meditation
• Mindful movement (“gentle yoga practiced with mindful awareness of the body”)
• Using all the senses
• Increasing awareness of breath, body sensations, thoughts, and emotional energy
• Mindfulness in everyday life
• Daily home practice of formal mindfulness meditation for 30 minutes per day, 5-6 days a week
• Discussing practice/exercises both in and outside class

Researchers tracked retention rates, any prohibited substance relapse, and four self-reported measures at 12, 24, and 36 weeks’ follow-up. The self-reported measures looked at craving, with the Desire for Drug Questionnaire; anxiety, with the Overall Anxiety Severity and Impairment Scale, range 0-20); depression, with the Overall Depression Severity and Impairment Scale, range 0-20; and mindfulness, with the Five Facet Mindfulness Questionnaire.

Participants in both groups were statistically similar in gender, employment, education, insurance, and marital status at baseline.

Of the 24 patients who entered the MBRP program, 14 completed the full 24 weeks of intervention and 12 subsequent weeks. Among the 36 participants who entered the treatment-as-usual group, 20 completed the 36 weeks.

Retention was 75% in both groups at 24 weeks, but retention from 24 to 36 weeks was nonsignificantly greater in the mindfulness group (93% vs. 91% treatment as usual).

Relapse at both 24 and 36 weeks was lower among those using mindfulness but without a statistically significant difference. At 24 weeks, 44% of the treatment-as-usual participants had relapsed at least once, compared with 33% of the MBRP participants (intent to treat).

At 36 weeks (n = 37), 45% of the 22 remaining in the treatment-as-usual group had relapsed, compared with 40% of the 15 in the MBRP group. However, 20% of those in MBRP (3 of 15) relapsed between the 24 and 36 week follow-ups, compared with 5% (1 of 22) in the treatment-as-usual group, still a nonsignificant difference.

Anxiety scores were higher at baseline in the MBRP group (11 MBRP vs. 7.25 TAU) but were similar in both groups at 36 weeks (5.79 MBRP vs. 5.6 TAU). Depression scores also were higher at baseline in the MBRP (8 vs. 6.3) but ended slightly lower than the treatment-as-usual group at 36 weeks (3.71 MBRP vs. 4.35 TAU). The reductions in depression and anxiety scores for the MBRP group were significantly greater than in the treatment-as-usual group.

Mindfulness scores were not significantly different at baseline between the groups but were significantly higher at 36 weeks in the mindfulness groups (3.47 vs. 3.3, range 1-5).

“Relapse rates were trending lower in the MBRP group although not statistically significant,” Dr. Zullig said. “Significant decreases occurred in craving in both MBRP and treatment-as-usual groups.”

The Centers for Disease Control and Prevention funded the research. The authors had no disclosures.

SAN ANTONIO – A mindfulness-based relapse prevention program resulted in significantly greater declines in anxiety and depressive symptoms among participants in an opioid addiction treatment program than those seen in patients who received treatment as usual, suggest results of a small nonrandomized controlled trial. Relapse rates trended downward with mindfulness but were not significantly different from the treatment-as-usual (TAU) group.

“Mindfulness-based relapse prevention (MBRP) can be successfully implemented in an outpatient setting with as good as or better results as treatment as usual,” Keith J. Zullig, PhD, MSPH, chair and professor in the department of social and behavioral sciences at the West Virginia University School of Public Health in Morgantown, said at the annual meeting of the College on Problems of Drug Dependence.

Though relapse rates did not show a statistically significant drop with mindfulness treatment compared with treatment as usual, the downward trend suggests that it is worthwhile to conduct a larger scale study, Dr. Zullig said.

The significant reductions in anxiety and depression scores among those practicing mindfulness suggest that MBRP particularly benefits patients with co-occurring mood disorders, he added.

The researchers recruited 60 participants from a Comprehensive Opioid Addiction Treatment program who had been substance free for at least 90 consecutive days. Participants chose whether to enter the MBRP group or the treatment-as-usual group.

The treatment-as-usual group attended biweekly 60-minute sessions with a cognitive-based therapy process group led by a licensed therapist for 36 weeks. The MBRP group involved 24 weeks of biweekly attendance at 60-minute sessions, also led by a licensed therapist, followed by 12 weeks in the treatment-as-usual group.

The MBRP instruction involved the following:

• Mindful skill building
• Breathing
• Meditation
• Mindful movement (“gentle yoga practiced with mindful awareness of the body”)
• Using all the senses
• Increasing awareness of breath, body sensations, thoughts, and emotional energy
• Mindfulness in everyday life
• Daily home practice of formal mindfulness meditation for 30 minutes per day, 5-6 days a week
• Discussing practice/exercises both in and outside class

Researchers tracked retention rates, any prohibited substance relapse, and four self-reported measures at 12, 24, and 36 weeks’ follow-up. The self-reported measures looked at craving, with the Desire for Drug Questionnaire; anxiety, with the Overall Anxiety Severity and Impairment Scale, range 0-20); depression, with the Overall Depression Severity and Impairment Scale, range 0-20; and mindfulness, with the Five Facet Mindfulness Questionnaire.

Participants in both groups were statistically similar in gender, employment, education, insurance, and marital status at baseline.

Of the 24 patients who entered the MBRP program, 14 completed the full 24 weeks of intervention and 12 subsequent weeks. Among the 36 participants who entered the treatment-as-usual group, 20 completed the 36 weeks.

Retention was 75% in both groups at 24 weeks, but retention from 24 to 36 weeks was nonsignificantly greater in the mindfulness group (93% vs. 91% treatment as usual).

Relapse at both 24 and 36 weeks was lower among those using mindfulness but without a statistically significant difference. At 24 weeks, 44% of the treatment-as-usual participants had relapsed at least once, compared with 33% of the MBRP participants (intent to treat).

At 36 weeks (n = 37), 45% of the 22 remaining in the treatment-as-usual group had relapsed, compared with 40% of the 15 in the MBRP group. However, 20% of those in MBRP (3 of 15) relapsed between the 24 and 36 week follow-ups, compared with 5% (1 of 22) in the treatment-as-usual group, still a nonsignificant difference.

Anxiety scores were higher at baseline in the MBRP group (11 MBRP vs. 7.25 TAU) but were similar in both groups at 36 weeks (5.79 MBRP vs. 5.6 TAU). Depression scores also were higher at baseline in the MBRP (8 vs. 6.3) but ended slightly lower than the treatment-as-usual group at 36 weeks (3.71 MBRP vs. 4.35 TAU). The reductions in depression and anxiety scores for the MBRP group were significantly greater than in the treatment-as-usual group.

Mindfulness scores were not significantly different at baseline between the groups but were significantly higher at 36 weeks in the mindfulness groups (3.47 vs. 3.3, range 1-5).

“Relapse rates were trending lower in the MBRP group although not statistically significant,” Dr. Zullig said. “Significant decreases occurred in craving in both MBRP and treatment-as-usual groups.”

The Centers for Disease Control and Prevention funded the research. The authors had no disclosures.

SAN ANTONIO – A perceived low risk of using methamphetamine and a belief that methamphetamine helps with opioid addiction are both driving increasing levels of concurrent methamphetamine and opioid use in rural Oregon, according to recent qualitative research.

Use of methamphetamine by those who use opioids increased from 19% to 34% between 2011 and 2017, Gillian Leichtling, research manager at HealthInsight Oregon, said at the annual meeting of the College on Problems of Drug Dependence.

The highest prevalence of simultaneous use is in the western states, where 63% of opioid users also use methamphetamine, she said. Hospitalizations and overdoses related to methamphetamine have likewise increased, particularly in rural communities.

To better understand the motivations and implications of this trend, Ms. Leichtling and her colleagues conducted a survey from March 2018 to April 2019 of adults who had nonmedically used/injected opioids or methamphetamine in the past month. All participants lived in Lane or Douglas counties in southwestern Oregon, where half the land is controlled by the U.S. Forest Service and Bureau of Land Management, and opioid overdose rates surpass that of the state average. Additional 60-minute semistructured qualitative interviews were conducted in summer 2018.

Among the 144 surveyed, 78% had used an opioid in the past month, nearly all of whom (96%) had also used methamphetamine in the past month. The interviewees included adults fairly evenly spread across ages, but most (94%) were white.

The main themes that emerged from the interviews involved the perceived benefits and consequences of those who used both opioids and methamphetamine, and the environmental circumstances that supported methamphetamine use, Ms. Leichtling explained.

Most people interviewed had their first experience with methamphetamine early in life, typically in early or mid-adolescence, she said. Two respondents, for example, first began using at 8 and 12 years old, the former learning from a preteen neighbor.

Methamphetamine’s wide availability and low cost also increased its use. In addition, methamphetamine use carries less stigma than heroin use, participants told the researchers. One person who noted the popularity of methamphetamine added: “You get treated really badly if you’re a heroin addict.”

In addition to less stigma, many of the perceived benefits of methamphetamine use related to opioids: Participants said methamphetamine “relieves opioid withdrawal, helps reduce opioid use, enhances functioning, and combines well with opioids” for a pleasurable effect, Ms. Leichtling said. Some also perceived methamphetamine as a way to reverse opioid overdose.

“I’m getting out of [the buprenorphine] program; they’re titrating me down rapidly, and so I’ve been sick for a week,” one respondent told researchers. “I’ve been doing so much more meth just to try to deflect the pain ... they’re too hard to come down from. It’s just you can’t do it without another drug ... especially if you have a job or responsibilities or kids,” they told researchers.

Another woman said she and her mother were able to come off heroin by using methamphetamine instead, and a yet another said she and her ex-boyfriend used methamphetamine to stop using opioids.

Several respondents also mentioned using methamphetamine to help them go to work, effectively put in long days, and then care for their families when they get home.

The two main drawbacks participants mentioned about methamphetamine were the risk of fentanyl adulteration and being discharged from medication treatment for opioid use disorder.

Ms. Leichtling described three main implications of the findings for interventions in rural areas. One was the need at the community level for greater access to medication-assisted treatment (MAT) of opioid use disorder to reduce the use of methamphetamine to taper opioid use or withdrawal.

Next, clinicians need to provide tailored treatment for the co-use of opioids and methamphetamine, and educate patients on alternatives to being dropped from medication-assisted opioid use disorder treatment. Finally, individual users need education on overdose that addresses the misconceptions and risks related to methamphetamine risk, Ms. Leichtling said.

Since the survey and interviews came only from two rural Oregon counties, the findings might not be generalizable, Ms. Leichtling said, and their study did not explore social determinants of health that might be at work.

The National Institute on Drug Abuse funded the research. The authors had no conflicts of interest.

SAN ANTONIO – A perceived low risk of using methamphetamine and a belief that methamphetamine helps with opioid addiction are both driving increasing levels of concurrent methamphetamine and opioid use in rural Oregon, according to recent qualitative research.

Use of methamphetamine by those who use opioids increased from 19% to 34% between 2011 and 2017, Gillian Leichtling, research manager at HealthInsight Oregon, said at the annual meeting of the College on Problems of Drug Dependence.

The highest prevalence of simultaneous use is in the western states, where 63% of opioid users also use methamphetamine, she said. Hospitalizations and overdoses related to methamphetamine have likewise increased, particularly in rural communities.

To better understand the motivations and implications of this trend, Ms. Leichtling and her colleagues conducted a survey from March 2018 to April 2019 of adults who had nonmedically used/injected opioids or methamphetamine in the past month. All participants lived in Lane or Douglas counties in southwestern Oregon, where half the land is controlled by the U.S. Forest Service and Bureau of Land Management, and opioid overdose rates surpass that of the state average. Additional 60-minute semistructured qualitative interviews were conducted in summer 2018.

Among the 144 surveyed, 78% had used an opioid in the past month, nearly all of whom (96%) had also used methamphetamine in the past month. The interviewees included adults fairly evenly spread across ages, but most (94%) were white.

The main themes that emerged from the interviews involved the perceived benefits and consequences of those who used both opioids and methamphetamine, and the environmental circumstances that supported methamphetamine use, Ms. Leichtling explained.

Most people interviewed had their first experience with methamphetamine early in life, typically in early or mid-adolescence, she said. Two respondents, for example, first began using at 8 and 12 years old, the former learning from a preteen neighbor.

Methamphetamine’s wide availability and low cost also increased its use. In addition, methamphetamine use carries less stigma than heroin use, participants told the researchers. One person who noted the popularity of methamphetamine added: “You get treated really badly if you’re a heroin addict.”

In addition to less stigma, many of the perceived benefits of methamphetamine use related to opioids: Participants said methamphetamine “relieves opioid withdrawal, helps reduce opioid use, enhances functioning, and combines well with opioids” for a pleasurable effect, Ms. Leichtling said. Some also perceived methamphetamine as a way to reverse opioid overdose.

“I’m getting out of [the buprenorphine] program; they’re titrating me down rapidly, and so I’ve been sick for a week,” one respondent told researchers. “I’ve been doing so much more meth just to try to deflect the pain ... they’re too hard to come down from. It’s just you can’t do it without another drug ... especially if you have a job or responsibilities or kids,” they told researchers.

Another woman said she and her mother were able to come off heroin by using methamphetamine instead, and a yet another said she and her ex-boyfriend used methamphetamine to stop using opioids.

Several respondents also mentioned using methamphetamine to help them go to work, effectively put in long days, and then care for their families when they get home.

The two main drawbacks participants mentioned about methamphetamine were the risk of fentanyl adulteration and being discharged from medication treatment for opioid use disorder.

Ms. Leichtling described three main implications of the findings for interventions in rural areas. One was the need at the community level for greater access to medication-assisted treatment (MAT) of opioid use disorder to reduce the use of methamphetamine to taper opioid use or withdrawal.

Next, clinicians need to provide tailored treatment for the co-use of opioids and methamphetamine, and educate patients on alternatives to being dropped from medication-assisted opioid use disorder treatment. Finally, individual users need education on overdose that addresses the misconceptions and risks related to methamphetamine risk, Ms. Leichtling said.

Since the survey and interviews came only from two rural Oregon counties, the findings might not be generalizable, Ms. Leichtling said, and their study did not explore social determinants of health that might be at work.

The National Institute on Drug Abuse funded the research. The authors had no conflicts of interest.

SAN ANTONIO – A perceived low risk of using methamphetamine and a belief that methamphetamine helps with opioid addiction are both driving increasing levels of concurrent methamphetamine and opioid use in rural Oregon, according to recent qualitative research.

Use of methamphetamine by those who use opioids increased from 19% to 34% between 2011 and 2017, Gillian Leichtling, research manager at HealthInsight Oregon, said at the annual meeting of the College on Problems of Drug Dependence.

The highest prevalence of simultaneous use is in the western states, where 63% of opioid users also use methamphetamine, she said. Hospitalizations and overdoses related to methamphetamine have likewise increased, particularly in rural communities.

To better understand the motivations and implications of this trend, Ms. Leichtling and her colleagues conducted a survey from March 2018 to April 2019 of adults who had nonmedically used/injected opioids or methamphetamine in the past month. All participants lived in Lane or Douglas counties in southwestern Oregon, where half the land is controlled by the U.S. Forest Service and Bureau of Land Management, and opioid overdose rates surpass that of the state average. Additional 60-minute semistructured qualitative interviews were conducted in summer 2018.

Among the 144 surveyed, 78% had used an opioid in the past month, nearly all of whom (96%) had also used methamphetamine in the past month. The interviewees included adults fairly evenly spread across ages, but most (94%) were white.

The main themes that emerged from the interviews involved the perceived benefits and consequences of those who used both opioids and methamphetamine, and the environmental circumstances that supported methamphetamine use, Ms. Leichtling explained.

Most people interviewed had their first experience with methamphetamine early in life, typically in early or mid-adolescence, she said. Two respondents, for example, first began using at 8 and 12 years old, the former learning from a preteen neighbor.

Methamphetamine’s wide availability and low cost also increased its use. In addition, methamphetamine use carries less stigma than heroin use, participants told the researchers. One person who noted the popularity of methamphetamine added: “You get treated really badly if you’re a heroin addict.”

In addition to less stigma, many of the perceived benefits of methamphetamine use related to opioids: Participants said methamphetamine “relieves opioid withdrawal, helps reduce opioid use, enhances functioning, and combines well with opioids” for a pleasurable effect, Ms. Leichtling said. Some also perceived methamphetamine as a way to reverse opioid overdose.

“I’m getting out of [the buprenorphine] program; they’re titrating me down rapidly, and so I’ve been sick for a week,” one respondent told researchers. “I’ve been doing so much more meth just to try to deflect the pain ... they’re too hard to come down from. It’s just you can’t do it without another drug ... especially if you have a job or responsibilities or kids,” they told researchers.

Another woman said she and her mother were able to come off heroin by using methamphetamine instead, and a yet another said she and her ex-boyfriend used methamphetamine to stop using opioids.

Several respondents also mentioned using methamphetamine to help them go to work, effectively put in long days, and then care for their families when they get home.

The two main drawbacks participants mentioned about methamphetamine were the risk of fentanyl adulteration and being discharged from medication treatment for opioid use disorder.

Ms. Leichtling described three main implications of the findings for interventions in rural areas. One was the need at the community level for greater access to medication-assisted treatment (MAT) of opioid use disorder to reduce the use of methamphetamine to taper opioid use or withdrawal.

Next, clinicians need to provide tailored treatment for the co-use of opioids and methamphetamine, and educate patients on alternatives to being dropped from medication-assisted opioid use disorder treatment. Finally, individual users need education on overdose that addresses the misconceptions and risks related to methamphetamine risk, Ms. Leichtling said.

Since the survey and interviews came only from two rural Oregon counties, the findings might not be generalizable, Ms. Leichtling said, and their study did not explore social determinants of health that might be at work.

The National Institute on Drug Abuse funded the research. The authors had no conflicts of interest.

SAN ANTONIO – Interventions aimed at educating parents about proper disposal methods for leftover prescription opioids and on explaining the risks of retaining opioids can increase the likelihood that parents will dispose of opioids when their children no longer need them, according to new research.

“Cost-effective disposal methods can nudge parents to dispose of their child’s leftover opioids promptly after use, but risk messaging is needed to best affect both early disposal and planned retention,” concluded Terri Voepel-Lewis, PhD, RN, of the University of Michigan, Ann Arbor, and colleagues.

“Such strategies can effectively reduce the presence of risky leftover medications in the home and decrease the risks posed to children and adolescents,” they wrote in a research poster at the annual meeting of College on Problems of Drug Dependence.

The researchers recruited 517 parents of children prescribed a short course of opioids, excluding children with chronic pain or the inability to report their pain.

The 255 parents randomly assigned to the nudge group received visual instructions on how to properly dispose of drugs while the 262 parents in the control group did not receive information on a disposal method. The groups were otherwise similar in terms of parent education, race/ethnicity, the child’s age and past opioid use, the parents’ past opioid use or misuse, whether opioids were kept in the home and whether the child’s procedure had been orthopedic/sports medicine–related.

Parents also were randomly assigned to routine care or to a Scenario-Tailored Opioid Messaging Program (STOMP). The STOMP group received tailored opioid risk information.

After a baseline survey on the child’s past pain, opioid use, misuse of opioids and risk perceptions, parents completed follow-up surveys at 7 and 14 days on opioid use, child pain, and behaviors related to retaining or disposing of opioids.

Just over a third of parents in the nudge group (34.7%) disposed of leftover opioids immediately after use, compared with 24% in the control group (odds ratio, 1.68; P = .01). Parents with the highest rate of disposal were those in the nudge group who participated in STOMP; they were more than twice as likely to dispose of opioids immediately after they were no longer needed (OR, 2.55; compared with control/non-STOMP).

A higher likelihood of disposal for parents in the nudge group alone, however, barely missed significance (OR, 1.77; P = .06) before adjustment. Parents’ intention to dispose of opioids was significantly different only among those who received STOMP education.

After the researchers controlled for child and parent factors, actual early disposal was significantly more likely in both the nudge and STOMP groups.

“Parental past opioid behaviors (kept an opioid in the home and past misuse) as well as orthopedic/sports medicine procedure were strongly associated with parents’ intention to retain [opioids],” the authors reported.

The study results revealed a divergence in parents’ intentions versus their behavior for one of the intervention groups.

“The nudge intervention improved parents’ prompt disposal of leftover prescription opioids but had no effect on planned retention rates,” the researchers reported. “In contrast, STOMP education had significant effects on early disposal behavior and planned retention. These findings suggest that clear and blunt messaging about the risks that opioids pose to household members is needed to reduce the presence of leftover opioids in the home.”

Additional findings regarding parents’ past behaviors suggested that those who have kept leftover opioids or previously misused them may see the risks of doing so as low, the authors noted.

“Importantly, parents’ past prescription opioid retention behavior doubled the risk for planned retention, and their past opioid misuse more than tripled the risk,” the researchers wrote. “Assessing parents’ past behaviors and enhancing their perceptions of the real risks posed to children are important targets for risk reduction.”

The National Institute on Drug Addiction funded the research. The authors reported having no conflicts of interest.

SAN ANTONIO – Interventions aimed at educating parents about proper disposal methods for leftover prescription opioids and on explaining the risks of retaining opioids can increase the likelihood that parents will dispose of opioids when their children no longer need them, according to new research.

“Cost-effective disposal methods can nudge parents to dispose of their child’s leftover opioids promptly after use, but risk messaging is needed to best affect both early disposal and planned retention,” concluded Terri Voepel-Lewis, PhD, RN, of the University of Michigan, Ann Arbor, and colleagues.

“Such strategies can effectively reduce the presence of risky leftover medications in the home and decrease the risks posed to children and adolescents,” they wrote in a research poster at the annual meeting of College on Problems of Drug Dependence.

The researchers recruited 517 parents of children prescribed a short course of opioids, excluding children with chronic pain or the inability to report their pain.

The 255 parents randomly assigned to the nudge group received visual instructions on how to properly dispose of drugs while the 262 parents in the control group did not receive information on a disposal method. The groups were otherwise similar in terms of parent education, race/ethnicity, the child’s age and past opioid use, the parents’ past opioid use or misuse, whether opioids were kept in the home and whether the child’s procedure had been orthopedic/sports medicine–related.

Parents also were randomly assigned to routine care or to a Scenario-Tailored Opioid Messaging Program (STOMP). The STOMP group received tailored opioid risk information.

After a baseline survey on the child’s past pain, opioid use, misuse of opioids and risk perceptions, parents completed follow-up surveys at 7 and 14 days on opioid use, child pain, and behaviors related to retaining or disposing of opioids.

Just over a third of parents in the nudge group (34.7%) disposed of leftover opioids immediately after use, compared with 24% in the control group (odds ratio, 1.68; P = .01). Parents with the highest rate of disposal were those in the nudge group who participated in STOMP; they were more than twice as likely to dispose of opioids immediately after they were no longer needed (OR, 2.55; compared with control/non-STOMP).

A higher likelihood of disposal for parents in the nudge group alone, however, barely missed significance (OR, 1.77; P = .06) before adjustment. Parents’ intention to dispose of opioids was significantly different only among those who received STOMP education.

After the researchers controlled for child and parent factors, actual early disposal was significantly more likely in both the nudge and STOMP groups.

“Parental past opioid behaviors (kept an opioid in the home and past misuse) as well as orthopedic/sports medicine procedure were strongly associated with parents’ intention to retain [opioids],” the authors reported.

The study results revealed a divergence in parents’ intentions versus their behavior for one of the intervention groups.

“The nudge intervention improved parents’ prompt disposal of leftover prescription opioids but had no effect on planned retention rates,” the researchers reported. “In contrast, STOMP education had significant effects on early disposal behavior and planned retention. These findings suggest that clear and blunt messaging about the risks that opioids pose to household members is needed to reduce the presence of leftover opioids in the home.”

Additional findings regarding parents’ past behaviors suggested that those who have kept leftover opioids or previously misused them may see the risks of doing so as low, the authors noted.

“Importantly, parents’ past prescription opioid retention behavior doubled the risk for planned retention, and their past opioid misuse more than tripled the risk,” the researchers wrote. “Assessing parents’ past behaviors and enhancing their perceptions of the real risks posed to children are important targets for risk reduction.”

The National Institute on Drug Addiction funded the research. The authors reported having no conflicts of interest.

SAN ANTONIO – Interventions aimed at educating parents about proper disposal methods for leftover prescription opioids and on explaining the risks of retaining opioids can increase the likelihood that parents will dispose of opioids when their children no longer need them, according to new research.

“Cost-effective disposal methods can nudge parents to dispose of their child’s leftover opioids promptly after use, but risk messaging is needed to best affect both early disposal and planned retention,” concluded Terri Voepel-Lewis, PhD, RN, of the University of Michigan, Ann Arbor, and colleagues.

“Such strategies can effectively reduce the presence of risky leftover medications in the home and decrease the risks posed to children and adolescents,” they wrote in a research poster at the annual meeting of College on Problems of Drug Dependence.

The researchers recruited 517 parents of children prescribed a short course of opioids, excluding children with chronic pain or the inability to report their pain.

The 255 parents randomly assigned to the nudge group received visual instructions on how to properly dispose of drugs while the 262 parents in the control group did not receive information on a disposal method. The groups were otherwise similar in terms of parent education, race/ethnicity, the child’s age and past opioid use, the parents’ past opioid use or misuse, whether opioids were kept in the home and whether the child’s procedure had been orthopedic/sports medicine–related.

Parents also were randomly assigned to routine care or to a Scenario-Tailored Opioid Messaging Program (STOMP). The STOMP group received tailored opioid risk information.

After a baseline survey on the child’s past pain, opioid use, misuse of opioids and risk perceptions, parents completed follow-up surveys at 7 and 14 days on opioid use, child pain, and behaviors related to retaining or disposing of opioids.

Just over a third of parents in the nudge group (34.7%) disposed of leftover opioids immediately after use, compared with 24% in the control group (odds ratio, 1.68; P = .01). Parents with the highest rate of disposal were those in the nudge group who participated in STOMP; they were more than twice as likely to dispose of opioids immediately after they were no longer needed (OR, 2.55; compared with control/non-STOMP).

A higher likelihood of disposal for parents in the nudge group alone, however, barely missed significance (OR, 1.77; P = .06) before adjustment. Parents’ intention to dispose of opioids was significantly different only among those who received STOMP education.

After the researchers controlled for child and parent factors, actual early disposal was significantly more likely in both the nudge and STOMP groups.

“Parental past opioid behaviors (kept an opioid in the home and past misuse) as well as orthopedic/sports medicine procedure were strongly associated with parents’ intention to retain [opioids],” the authors reported.

The study results revealed a divergence in parents’ intentions versus their behavior for one of the intervention groups.

“The nudge intervention improved parents’ prompt disposal of leftover prescription opioids but had no effect on planned retention rates,” the researchers reported. “In contrast, STOMP education had significant effects on early disposal behavior and planned retention. These findings suggest that clear and blunt messaging about the risks that opioids pose to household members is needed to reduce the presence of leftover opioids in the home.”

Additional findings regarding parents’ past behaviors suggested that those who have kept leftover opioids or previously misused them may see the risks of doing so as low, the authors noted.

“Importantly, parents’ past prescription opioid retention behavior doubled the risk for planned retention, and their past opioid misuse more than tripled the risk,” the researchers wrote. “Assessing parents’ past behaviors and enhancing their perceptions of the real risks posed to children are important targets for risk reduction.”

The National Institute on Drug Addiction funded the research. The authors reported having no conflicts of interest.

SAN ANTONIO – Of 196 U.S. youth who reported use of at least one prescribed stimulant in their lifetimes, 25% also said they used the drugs nonmedically, based on a survey of children and adolescents aged 10-17 years.

Another 5% of the youth surveyed reported exclusively nonmedical use of stimulants. The survey participants lived in six U.S. cities and their outlying areas.

“Parents of both users and nonusers should warn their children of the dangers of using others’ stimulants and giving their own stimulants to others,” concluded Linda B. Cottler, PhD, MPH of the University of Florida, and colleagues.

“Physicians and pharmacists should make users and their families aware of the need to take medications as prescribed and not to share medications with others,” they wrote in their research poster at the annual meeting of the College on Problems of Drug Dependence. “Continuous monitoring of these medications in the community should be a priority.”

Though prevalence research has shown increasing stimulant misuse among youth, little data exist for younger children, the researchers noted. They therefore conducted a survey of 1,777 youth aged 10-17 years from September to October 2018 in six cities in California, Texas, and Florida, the most populous U.S. states.

The participants included youth from urban, rural, and suburban areas of Los Angeles, Dallas, Houston, Tampa, Orlando, and Miami. Trained graduate students and professional raters approached the respondents in entertainment venues and obtained assent but did not require parental consent. The respondents received $30 for completing the survey.

A total of 11.1% of respondents reporting having used prescription stimulants in their lifetime, and 7.6% had done so in the past 30 days. Just under a third of those who used stimulants (30.1%) did so for nonmedical purposes, defined as taking the stimulant nonorally (except for the patch Daytrana), getting the stimulant from someone else, or taking more of the drug than prescribed.

A quarter of the respondents who used stimulants reported both medical use and nonmedical use. And 5.1% of these youths reported only using stimulants nonmedically.

Among those with any lifetime stimulant use, 13.8% reported nonoral administration, including 9.7% who snorted or sniffed the drugs, 4.1% who smoked them, and 1.0% who injected them. Just over half (51.8%) of those reporting nonoral use had also used prescription stimulants orally.

The likelihood of using stimulants nonmedically increased with age (P less than .0001). The researchers found no significant associations between nonmedical use and geography or race/ethnicity. Among 10- to 12-year-olds, 3.1% reported only medical use of stimulants, and 0.7% (2 of 286 respondents in this age group) reported any nonmedical use of stimulants.

Of those aged 13-15 years, 2.1% reported any nonmedical stimulant use.

Nonmedical stimulant use was reported by twice as many boys (67.8%) as girls (32.2%), though this finding may not be surprising as the majority of nonmedical users were also medical users and stimulants are prescribed more frequently to boys than to girls (P less than .0006).

The research was funded by Arbor Pharmaceuticals. The authors noted no conflicts of interest.

SAN ANTONIO – Of 196 U.S. youth who reported use of at least one prescribed stimulant in their lifetimes, 25% also said they used the drugs nonmedically, based on a survey of children and adolescents aged 10-17 years.

Another 5% of the youth surveyed reported exclusively nonmedical use of stimulants. The survey participants lived in six U.S. cities and their outlying areas.

“Parents of both users and nonusers should warn their children of the dangers of using others’ stimulants and giving their own stimulants to others,” concluded Linda B. Cottler, PhD, MPH of the University of Florida, and colleagues.

“Physicians and pharmacists should make users and their families aware of the need to take medications as prescribed and not to share medications with others,” they wrote in their research poster at the annual meeting of the College on Problems of Drug Dependence. “Continuous monitoring of these medications in the community should be a priority.”

Though prevalence research has shown increasing stimulant misuse among youth, little data exist for younger children, the researchers noted. They therefore conducted a survey of 1,777 youth aged 10-17 years from September to October 2018 in six cities in California, Texas, and Florida, the most populous U.S. states.

The participants included youth from urban, rural, and suburban areas of Los Angeles, Dallas, Houston, Tampa, Orlando, and Miami. Trained graduate students and professional raters approached the respondents in entertainment venues and obtained assent but did not require parental consent. The respondents received $30 for completing the survey.

A total of 11.1% of respondents reporting having used prescription stimulants in their lifetime, and 7.6% had done so in the past 30 days. Just under a third of those who used stimulants (30.1%) did so for nonmedical purposes, defined as taking the stimulant nonorally (except for the patch Daytrana), getting the stimulant from someone else, or taking more of the drug than prescribed.

A quarter of the respondents who used stimulants reported both medical use and nonmedical use. And 5.1% of these youths reported only using stimulants nonmedically.

Among those with any lifetime stimulant use, 13.8% reported nonoral administration, including 9.7% who snorted or sniffed the drugs, 4.1% who smoked them, and 1.0% who injected them. Just over half (51.8%) of those reporting nonoral use had also used prescription stimulants orally.

The likelihood of using stimulants nonmedically increased with age (P less than .0001). The researchers found no significant associations between nonmedical use and geography or race/ethnicity. Among 10- to 12-year-olds, 3.1% reported only medical use of stimulants, and 0.7% (2 of 286 respondents in this age group) reported any nonmedical use of stimulants.

Of those aged 13-15 years, 2.1% reported any nonmedical stimulant use.

Nonmedical stimulant use was reported by twice as many boys (67.8%) as girls (32.2%), though this finding may not be surprising as the majority of nonmedical users were also medical users and stimulants are prescribed more frequently to boys than to girls (P less than .0006).

The research was funded by Arbor Pharmaceuticals. The authors noted no conflicts of interest.

SAN ANTONIO – Of 196 U.S. youth who reported use of at least one prescribed stimulant in their lifetimes, 25% also said they used the drugs nonmedically, based on a survey of children and adolescents aged 10-17 years.

Another 5% of the youth surveyed reported exclusively nonmedical use of stimulants. The survey participants lived in six U.S. cities and their outlying areas.

“Parents of both users and nonusers should warn their children of the dangers of using others’ stimulants and giving their own stimulants to others,” concluded Linda B. Cottler, PhD, MPH of the University of Florida, and colleagues.

“Physicians and pharmacists should make users and their families aware of the need to take medications as prescribed and not to share medications with others,” they wrote in their research poster at the annual meeting of the College on Problems of Drug Dependence. “Continuous monitoring of these medications in the community should be a priority.”

Though prevalence research has shown increasing stimulant misuse among youth, little data exist for younger children, the researchers noted. They therefore conducted a survey of 1,777 youth aged 10-17 years from September to October 2018 in six cities in California, Texas, and Florida, the most populous U.S. states.

The participants included youth from urban, rural, and suburban areas of Los Angeles, Dallas, Houston, Tampa, Orlando, and Miami. Trained graduate students and professional raters approached the respondents in entertainment venues and obtained assent but did not require parental consent. The respondents received $30 for completing the survey.

A total of 11.1% of respondents reporting having used prescription stimulants in their lifetime, and 7.6% had done so in the past 30 days. Just under a third of those who used stimulants (30.1%) did so for nonmedical purposes, defined as taking the stimulant nonorally (except for the patch Daytrana), getting the stimulant from someone else, or taking more of the drug than prescribed.

A quarter of the respondents who used stimulants reported both medical use and nonmedical use. And 5.1% of these youths reported only using stimulants nonmedically.

Among those with any lifetime stimulant use, 13.8% reported nonoral administration, including 9.7% who snorted or sniffed the drugs, 4.1% who smoked them, and 1.0% who injected them. Just over half (51.8%) of those reporting nonoral use had also used prescription stimulants orally.

The likelihood of using stimulants nonmedically increased with age (P less than .0001). The researchers found no significant associations between nonmedical use and geography or race/ethnicity. Among 10- to 12-year-olds, 3.1% reported only medical use of stimulants, and 0.7% (2 of 286 respondents in this age group) reported any nonmedical use of stimulants.

Of those aged 13-15 years, 2.1% reported any nonmedical stimulant use.

Nonmedical stimulant use was reported by twice as many boys (67.8%) as girls (32.2%), though this finding may not be surprising as the majority of nonmedical users were also medical users and stimulants are prescribed more frequently to boys than to girls (P less than .0006).

The research was funded by Arbor Pharmaceuticals. The authors noted no conflicts of interest.

SAN ANTONIO – Episodic migraine patients benefit from mindfulness-based stress reduction training, according to new research. The intervention reduced headache frequency, slightly increased whole-brain gray matter volume, and reduced symptoms of anxiety, depression, and stress.

stockdevil/Thinkstock

The gray matter findings may indicate opportunities for therapeutic targets, while the psychosocial findings are important in understanding migraine burden, treatment response, and personalized medicine opportunities, Shana Burrowes, PhD, a postdoctoral associate at Boston University, said at the annual meeting of the College on Problems of Drug Dependence.

In a session focused on exploring alternatives to opioids for pain treatment, Dr. Burrowes described interim results of a randomized, controlled trial testing the effectiveness of mindfulness-based stress reduction (MBSR) training for managing migraine.

In discussing the rationale for study endpoints, she explained a three-pronged model for understanding migraine. Those elements include the symptoms themselves – unilateral throbbing pain, nausea, and photophobia – and the psychosocial symptoms and comorbidities, including anxiety, depression, stress, and catastrophizing. Up to 30%* of migraine patients have comorbid depression.

Those two prongs have a bidirectional relationship, since each increases the risk of the other. For example, frequent migraine can leave people feeling anxious about when their next migraine will occur, and that anxiety can increase the risk of it occurring.

Both elements lead to the third prong, which is change in gray matter volume. “If you’re a patient with migraine, an MRI on your brain is going to look different from somebody who does not have migraine,” Dr. Burrowes said. “With all these things going on in a patient, a migraine patient is actually pretty difficult to treat.”

Therefore, the researchers focused on outcomes from each of these three domains: gray matter volume in MRI; headache frequency as a clinical outcome; and the psychosocial comorbidities of anxiety, stress, and depression.

Study participants included 98 patients with episodic migraine, defined as fewer than 15 headache days a month, and 27 controls* matched by demographics to the patients and without any chronic pain conditions. The groups were 92% female and had similar ratios of whites (75% and 77%) and college graduates (95% and 96%).

Only the patients were randomized to the two interventions, one a training on MBSR and the other focusing on stress management for headache (SMH).

The MBSR training involved group sessions, eight 2.5-hour meditation sessions, at-home practice, a half-day retreat, and then an additional four biweekly sessions. The mindfulness training specifically focused on intentionally paying attention in the moment without judgment. The SMH arm focused on education for managing headache symptoms, stress, sleep hygiene, and diet, but it did not involve any specific skills training, such as relaxation training.

All participants, including healthy controls, underwent clinical assessment and baseline MRI and psychosocial questionnaires, followed by MRI and psychosocial questionnaire follow-ups at 3 and 6 months. MRI imaging focused on the whole brain and on the bilateral insula, dorsolateral prefrontal cortex, anterior cingulate cortex, and superior frontal gyrus. Patients also kept headache diaries throughout the trial.

Both intervention groups showed an increase in gray matter volume over 6 months, compared with healthy controls: 1.3% in the whole brain for SMH participants and 1.01% in the MBSR patients, compared with –1.37% in healthy participants. In the right superior frontal gyrus, gray matter volume also increased 2.62% in SMH participants and 1.25% in MBSR patients but decreased 0.19% in healthy participants.

Dr. Burrowes said she could not share specific findings on headache frequency and psychosocial outcomes because her team’s research is currently under review. Overall, however, headache frequency declined more than 50% post intervention, and 39% of migraine patients responded to the therapy.

In addition, anxiety, stress, and depression symptoms all saw improvements from MBSR and slightly but significantly mediated the effect of MBSR on migraine reduction.

Dr. Burrowes reported having no disclosures.

*The story was updated 6/20/2019.

SAN ANTONIO – Episodic migraine patients benefit from mindfulness-based stress reduction training, according to new research. The intervention reduced headache frequency, slightly increased whole-brain gray matter volume, and reduced symptoms of anxiety, depression, and stress.

stockdevil/Thinkstock

The gray matter findings may indicate opportunities for therapeutic targets, while the psychosocial findings are important in understanding migraine burden, treatment response, and personalized medicine opportunities, Shana Burrowes, PhD, a postdoctoral associate at Boston University, said at the annual meeting of the College on Problems of Drug Dependence.

In a session focused on exploring alternatives to opioids for pain treatment, Dr. Burrowes described interim results of a randomized, controlled trial testing the effectiveness of mindfulness-based stress reduction (MBSR) training for managing migraine.

In discussing the rationale for study endpoints, she explained a three-pronged model for understanding migraine. Those elements include the symptoms themselves – unilateral throbbing pain, nausea, and photophobia – and the psychosocial symptoms and comorbidities, including anxiety, depression, stress, and catastrophizing. Up to 30%* of migraine patients have comorbid depression.

Those two prongs have a bidirectional relationship, since each increases the risk of the other. For example, frequent migraine can leave people feeling anxious about when their next migraine will occur, and that anxiety can increase the risk of it occurring.

Both elements lead to the third prong, which is change in gray matter volume. “If you’re a patient with migraine, an MRI on your brain is going to look different from somebody who does not have migraine,” Dr. Burrowes said. “With all these things going on in a patient, a migraine patient is actually pretty difficult to treat.”

Therefore, the researchers focused on outcomes from each of these three domains: gray matter volume in MRI; headache frequency as a clinical outcome; and the psychosocial comorbidities of anxiety, stress, and depression.

Study participants included 98 patients with episodic migraine, defined as fewer than 15 headache days a month, and 27 controls* matched by demographics to the patients and without any chronic pain conditions. The groups were 92% female and had similar ratios of whites (75% and 77%) and college graduates (95% and 96%).

Only the patients were randomized to the two interventions, one a training on MBSR and the other focusing on stress management for headache (SMH).

The MBSR training involved group sessions, eight 2.5-hour meditation sessions, at-home practice, a half-day retreat, and then an additional four biweekly sessions. The mindfulness training specifically focused on intentionally paying attention in the moment without judgment. The SMH arm focused on education for managing headache symptoms, stress, sleep hygiene, and diet, but it did not involve any specific skills training, such as relaxation training.

All participants, including healthy controls, underwent clinical assessment and baseline MRI and psychosocial questionnaires, followed by MRI and psychosocial questionnaire follow-ups at 3 and 6 months. MRI imaging focused on the whole brain and on the bilateral insula, dorsolateral prefrontal cortex, anterior cingulate cortex, and superior frontal gyrus. Patients also kept headache diaries throughout the trial.

Both intervention groups showed an increase in gray matter volume over 6 months, compared with healthy controls: 1.3% in the whole brain for SMH participants and 1.01% in the MBSR patients, compared with –1.37% in healthy participants. In the right superior frontal gyrus, gray matter volume also increased 2.62% in SMH participants and 1.25% in MBSR patients but decreased 0.19% in healthy participants.

Dr. Burrowes said she could not share specific findings on headache frequency and psychosocial outcomes because her team’s research is currently under review. Overall, however, headache frequency declined more than 50% post intervention, and 39% of migraine patients responded to the therapy.

In addition, anxiety, stress, and depression symptoms all saw improvements from MBSR and slightly but significantly mediated the effect of MBSR on migraine reduction.

Dr. Burrowes reported having no disclosures.

*The story was updated 6/20/2019.

SAN ANTONIO – Episodic migraine patients benefit from mindfulness-based stress reduction training, according to new research. The intervention reduced headache frequency, slightly increased whole-brain gray matter volume, and reduced symptoms of anxiety, depression, and stress.

stockdevil/Thinkstock

The gray matter findings may indicate opportunities for therapeutic targets, while the psychosocial findings are important in understanding migraine burden, treatment response, and personalized medicine opportunities, Shana Burrowes, PhD, a postdoctoral associate at Boston University, said at the annual meeting of the College on Problems of Drug Dependence.

In a session focused on exploring alternatives to opioids for pain treatment, Dr. Burrowes described interim results of a randomized, controlled trial testing the effectiveness of mindfulness-based stress reduction (MBSR) training for managing migraine.

In discussing the rationale for study endpoints, she explained a three-pronged model for understanding migraine. Those elements include the symptoms themselves – unilateral throbbing pain, nausea, and photophobia – and the psychosocial symptoms and comorbidities, including anxiety, depression, stress, and catastrophizing. Up to 30%* of migraine patients have comorbid depression.

Those two prongs have a bidirectional relationship, since each increases the risk of the other. For example, frequent migraine can leave people feeling anxious about when their next migraine will occur, and that anxiety can increase the risk of it occurring.

Both elements lead to the third prong, which is change in gray matter volume. “If you’re a patient with migraine, an MRI on your brain is going to look different from somebody who does not have migraine,” Dr. Burrowes said. “With all these things going on in a patient, a migraine patient is actually pretty difficult to treat.”

Therefore, the researchers focused on outcomes from each of these three domains: gray matter volume in MRI; headache frequency as a clinical outcome; and the psychosocial comorbidities of anxiety, stress, and depression.

Study participants included 98 patients with episodic migraine, defined as fewer than 15 headache days a month, and 27 controls* matched by demographics to the patients and without any chronic pain conditions. The groups were 92% female and had similar ratios of whites (75% and 77%) and college graduates (95% and 96%).

Only the patients were randomized to the two interventions, one a training on MBSR and the other focusing on stress management for headache (SMH).

The MBSR training involved group sessions, eight 2.5-hour meditation sessions, at-home practice, a half-day retreat, and then an additional four biweekly sessions. The mindfulness training specifically focused on intentionally paying attention in the moment without judgment. The SMH arm focused on education for managing headache symptoms, stress, sleep hygiene, and diet, but it did not involve any specific skills training, such as relaxation training.

All participants, including healthy controls, underwent clinical assessment and baseline MRI and psychosocial questionnaires, followed by MRI and psychosocial questionnaire follow-ups at 3 and 6 months. MRI imaging focused on the whole brain and on the bilateral insula, dorsolateral prefrontal cortex, anterior cingulate cortex, and superior frontal gyrus. Patients also kept headache diaries throughout the trial.

Both intervention groups showed an increase in gray matter volume over 6 months, compared with healthy controls: 1.3% in the whole brain for SMH participants and 1.01% in the MBSR patients, compared with –1.37% in healthy participants. In the right superior frontal gyrus, gray matter volume also increased 2.62% in SMH participants and 1.25% in MBSR patients but decreased 0.19% in healthy participants.

Dr. Burrowes said she could not share specific findings on headache frequency and psychosocial outcomes because her team’s research is currently under review. Overall, however, headache frequency declined more than 50% post intervention, and 39% of migraine patients responded to the therapy.

In addition, anxiety, stress, and depression symptoms all saw improvements from MBSR and slightly but significantly mediated the effect of MBSR on migraine reduction.

Dr. Burrowes reported having no disclosures.

*The story was updated 6/20/2019.

SAN ANTONIO – People who smoke and have opioid use disorder have a lower likelihood of drug use several months after initiating smoking cessation treatment if they are treated with nicotine replacement therapy rather than varenicline, new research suggests.

“Differences were not due to the pretreatment differences in drug use, which were covaried,” wrote Damaris J. Rohsenow, PhD, and colleagues at Brown University’s Center for Alcohol and Addiction Studies, Providence, R.I. “Results suggest it may be preferable to offer smokers with opioid use disorder [nicotine replacement therapy] rather than varenicline, given their lower adherence and more illicit drug use days during follow-up when given varenicline compared to [nicotine replacement therapy].”

They shared their research poster at the annual meeting of the College on Problems of Drug Dependence.

About 80%-90% of patients with OUD smoke, and those patients have a particularly difficult time with smoking cessation partly because of nonadherence to cessation medications, the authors noted. Smoking increases the risk of relapse from any substance use disorder, and pain – frequently comorbid with smoking – contributes to opioid use, they added.

Though smoking treatment has been shown not to increase drug or alcohol use, varenicline and nicotine replacement therapy have different effects on a4b2 nicotinic acetylcholinergic receptors (nAChRs). The authors noted that nicotine offers greater pain inhibition via full agonist effects across multiple nAChRs, whereas varenicline has only a partial agonist effect on a single nAChR.

“Smokers may receive more rewarding dopamine effects from the full nicotine agonist,” they wrote. The researchers therefore aimed to compare responses to nicotine replacement therapy and varenicline among smokers with and without OUD.

Ninety patients without OUD and 47 patients with it were randomly assigned to receive transdermal nicotine replacement therapy with placebo capsules or varenicline capsules with a placebo patch for 12 weeks with 3- and 6-month follow-ups. At baseline, those with OUD were significantly more likely to be white and slightly younger and have twice as many drug use days than those without the disorder.

Differences also existed between those with and without OUD for comorbid alcohol use disorder (55% vs. 81%), marijuana use disorder (32% vs. 19%) and cocaine use disorder (70% vs. 55%).

Those without OUD had slightly greater medication adherence, but with only borderline significance just among those taking varenicline. Loss to follow-up, meanwhile, was significantly greater for those with OUD in both treatment groups.

Most striking was the significantly higher number of drug use days among those with OUD who took varenicline vs. all other groups. Those patients had 16.5 drug use days at 4-6 months’ follow-up, compared with 0.13 days among those with OUD using nicotine replacement therapy (P less than .026). Among those without OUD, nicotine replacement therapy patients had 5 drug use days, and varenicline patients had 2.5 drug use days.

“Given interactions between nicotine and the opioid system and given that [nicotine replacement therapy] binds to more types of nAChRs than varenicline does, it is possible that [nicotine replacement therapy] dampens desire to use opiates compared to varenicline by stimulating more nAChRs,” the authors wrote. “Increasing nicotine dose may be better for smokers with opioid use disorder,” they added, though they noted the small size of the study and the need for replication with larger populations.

The research was funded by the National Institute on Drug Abuse and the Department of Veterans Affairs. The authors reported no disclosures.

SAN ANTONIO – People who smoke and have opioid use disorder have a lower likelihood of drug use several months after initiating smoking cessation treatment if they are treated with nicotine replacement therapy rather than varenicline, new research suggests.

“Differences were not due to the pretreatment differences in drug use, which were covaried,” wrote Damaris J. Rohsenow, PhD, and colleagues at Brown University’s Center for Alcohol and Addiction Studies, Providence, R.I. “Results suggest it may be preferable to offer smokers with opioid use disorder [nicotine replacement therapy] rather than varenicline, given their lower adherence and more illicit drug use days during follow-up when given varenicline compared to [nicotine replacement therapy].”

They shared their research poster at the annual meeting of the College on Problems of Drug Dependence.

About 80%-90% of patients with OUD smoke, and those patients have a particularly difficult time with smoking cessation partly because of nonadherence to cessation medications, the authors noted. Smoking increases the risk of relapse from any substance use disorder, and pain – frequently comorbid with smoking – contributes to opioid use, they added.

Though smoking treatment has been shown not to increase drug or alcohol use, varenicline and nicotine replacement therapy have different effects on a4b2 nicotinic acetylcholinergic receptors (nAChRs). The authors noted that nicotine offers greater pain inhibition via full agonist effects across multiple nAChRs, whereas varenicline has only a partial agonist effect on a single nAChR.

“Smokers may receive more rewarding dopamine effects from the full nicotine agonist,” they wrote. The researchers therefore aimed to compare responses to nicotine replacement therapy and varenicline among smokers with and without OUD.

Ninety patients without OUD and 47 patients with it were randomly assigned to receive transdermal nicotine replacement therapy with placebo capsules or varenicline capsules with a placebo patch for 12 weeks with 3- and 6-month follow-ups. At baseline, those with OUD were significantly more likely to be white and slightly younger and have twice as many drug use days than those without the disorder.

Differences also existed between those with and without OUD for comorbid alcohol use disorder (55% vs. 81%), marijuana use disorder (32% vs. 19%) and cocaine use disorder (70% vs. 55%).

Those without OUD had slightly greater medication adherence, but with only borderline significance just among those taking varenicline. Loss to follow-up, meanwhile, was significantly greater for those with OUD in both treatment groups.

Most striking was the significantly higher number of drug use days among those with OUD who took varenicline vs. all other groups. Those patients had 16.5 drug use days at 4-6 months’ follow-up, compared with 0.13 days among those with OUD using nicotine replacement therapy (P less than .026). Among those without OUD, nicotine replacement therapy patients had 5 drug use days, and varenicline patients had 2.5 drug use days.

“Given interactions between nicotine and the opioid system and given that [nicotine replacement therapy] binds to more types of nAChRs than varenicline does, it is possible that [nicotine replacement therapy] dampens desire to use opiates compared to varenicline by stimulating more nAChRs,” the authors wrote. “Increasing nicotine dose may be better for smokers with opioid use disorder,” they added, though they noted the small size of the study and the need for replication with larger populations.

The research was funded by the National Institute on Drug Abuse and the Department of Veterans Affairs. The authors reported no disclosures.

SAN ANTONIO – People who smoke and have opioid use disorder have a lower likelihood of drug use several months after initiating smoking cessation treatment if they are treated with nicotine replacement therapy rather than varenicline, new research suggests.

“Differences were not due to the pretreatment differences in drug use, which were covaried,” wrote Damaris J. Rohsenow, PhD, and colleagues at Brown University’s Center for Alcohol and Addiction Studies, Providence, R.I. “Results suggest it may be preferable to offer smokers with opioid use disorder [nicotine replacement therapy] rather than varenicline, given their lower adherence and more illicit drug use days during follow-up when given varenicline compared to [nicotine replacement therapy].”

They shared their research poster at the annual meeting of the College on Problems of Drug Dependence.

About 80%-90% of patients with OUD smoke, and those patients have a particularly difficult time with smoking cessation partly because of nonadherence to cessation medications, the authors noted. Smoking increases the risk of relapse from any substance use disorder, and pain – frequently comorbid with smoking – contributes to opioid use, they added.

Though smoking treatment has been shown not to increase drug or alcohol use, varenicline and nicotine replacement therapy have different effects on a4b2 nicotinic acetylcholinergic receptors (nAChRs). The authors noted that nicotine offers greater pain inhibition via full agonist effects across multiple nAChRs, whereas varenicline has only a partial agonist effect on a single nAChR.

“Smokers may receive more rewarding dopamine effects from the full nicotine agonist,” they wrote. The researchers therefore aimed to compare responses to nicotine replacement therapy and varenicline among smokers with and without OUD.

Ninety patients without OUD and 47 patients with it were randomly assigned to receive transdermal nicotine replacement therapy with placebo capsules or varenicline capsules with a placebo patch for 12 weeks with 3- and 6-month follow-ups. At baseline, those with OUD were significantly more likely to be white and slightly younger and have twice as many drug use days than those without the disorder.

Differences also existed between those with and without OUD for comorbid alcohol use disorder (55% vs. 81%), marijuana use disorder (32% vs. 19%) and cocaine use disorder (70% vs. 55%).

Those without OUD had slightly greater medication adherence, but with only borderline significance just among those taking varenicline. Loss to follow-up, meanwhile, was significantly greater for those with OUD in both treatment groups.

Most striking was the significantly higher number of drug use days among those with OUD who took varenicline vs. all other groups. Those patients had 16.5 drug use days at 4-6 months’ follow-up, compared with 0.13 days among those with OUD using nicotine replacement therapy (P less than .026). Among those without OUD, nicotine replacement therapy patients had 5 drug use days, and varenicline patients had 2.5 drug use days.

“Given interactions between nicotine and the opioid system and given that [nicotine replacement therapy] binds to more types of nAChRs than varenicline does, it is possible that [nicotine replacement therapy] dampens desire to use opiates compared to varenicline by stimulating more nAChRs,” the authors wrote. “Increasing nicotine dose may be better for smokers with opioid use disorder,” they added, though they noted the small size of the study and the need for replication with larger populations.

The research was funded by the National Institute on Drug Abuse and the Department of Veterans Affairs. The authors reported no disclosures.