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Sex Differences in Opioid Use and Medical Issues During Buprenorphine/Naloxone Treatment.

American Journal of Drug and Alcohol Abuse 2018;44(4):488-496. [doi: 10.1080/00952990.2018.1458234]

Celestina Barbosa-Leiker, PhD, Sterling McPherson, PhD, Matthew E. Layton, MD, Ekaterina Burduli, PhD, John M. Roll, PhD (all previous from Washington State University, PN Node), Walter Ling, MD (University of California, Los Angeles).

There are sex differences in buprenorphine/naloxone clinical trials for opioid use. While women have fewer opioid-positive urine samples, relative to men, a significant decrease in opioid-positive samples was found during treatment for men, but not women. In order to inform sex-based approaches to improve treatment outcomes, research is needed to determine if opioid use, and predictors of opioid use, differs between men and women during treatment. This secondary analysis of the NIDA Clinical Trials Network study CTN-0003, a randomized clinical trial comparing 7-day vs. 28-day buprenorphine/naloxone tapering strategies, examined sex differences (men=347, women=169) in opioid-positive samples. Addiction-related problem areas were defined by Addiction Severity Index-Lite (ASI-L) domain composite scores.

Results found that women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial, and medical issues were positive related to submitting an opioid-positive sample during treatment for women. No ASI-L domain composite score was associated with opioid-positive samples during treatment for me.

Conclusions: Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial, and medical issues predicted opioid use during treatment for women but not men. These findings suggest that additional tests of sex differences in buprenorphine/naloxone clinical trials are warranted to further verify that women have increased opioid use during treatment. In addition, sex-specific risk factors such as medical problems may assist in developing more precise treatment strategies to couple with buprenorphine/naloxone therapy. Our findings demonstrate an increase in opioid use during treatment in relation to medical problems for women, suggesting that complementary treatment for medical problems during opioid replacement therapy would benefit women. Failure to address these needs may result in less successful opioid treatment for women. (Article (Peer-Reviewed), PDF, English, 2018)

Keywords: Buprenorphine/Naloxone |CTN platform/ancillary study | Gender differences | Pharmacological therapy | Opioid dependence | Women | American Journal of Drug and Alcohol Abuse (journal)

Document No: 1312, PMID: 29672167.

Submitted by CTN Dissemination Librarians, 4/26/2018.


Barbosa-Leiker, Celestina mail
Burduli, Ekaterina mail
Layton, Matthew E.
Ling, Walter
McPherson, Sterling mail
Roll, John M.
NIDA-CTN-0003 www
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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 8/2018 --
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