@article{67f0e5652e884e42b46df0c4d70e9df4,
title = "Sexual orientation differences among men in a randomized clinical trial of extended-release naltrexone and bupropion for methamphetamine use disorder",
abstract = "Background: Methamphetamine use disorder (MethUD) disproportionately affects men who have sex exclusively with men or with men and women (collectively MSM/W), compared to men who have sex with women (MSW). This study is the first MethUD medication trial to compare treatment effect for these groups, hypothesizing that extended-release injectable naltrexone 380 mg every 3 weeks plus oral extended-release bupropion 450 mg daily would be less effective for MSM/W than MSW. Methods: Data come from men (N = 246) in a multi-site, double-blind, randomized, placebo-controlled trial with sequential parallel comparison design. In Stage 1 (6-weeks), participants were randomized to active treatment or placebo. In Stage 2 (6-weeks), Stage 1 placebo non-responders were rerandomized. Treatment response was ≥3 methamphetamine-negative urine samples, out of four obtained at the end of Stages 1 and 2. Treatment effect was the active-versus-placebo between-group difference in the weighted average Stages 1 and 2 responses. Results: MSM/W (n = 151) were more likely than MSW (n = 95) to be Hispanic, college-educated, and living with HIV. Adjusting for demographics, among MSM/W, response rates were 13.95 % (active treatment) and 2.78 % (placebo) in Stage 1; 23.26 % (active treatment) and 4.26 % (placebo) in Stage 2. Among MSW, response rates were 7.69 % (active treatment) and 5.80 % (placebo) in Stage 1; 3.57 % (active treatment) and 0 % (placebo) in Stage 2. Treatment effect was significantly larger for MSM/W (h = 0.1479) than MSW (h = 0.0227) (p = 0.04). Conclusions: Findings suggest efficacy of extended-release naltrexone plus bupropion for MSM/W, a population heavily burdened by MethUD. While a secondary outcome, this intriguing finding merits testing in prospective trials.",
keywords = "Addiction, Bisexual, Gay, Methamphetamine, Psychopharmacology, Stimulants",
author = "Kidd, {Jeremy D.} and Smiley, {Sabrina L.} and Coffin, {Phillip O.} and Carmody, {Thomas J.} and Levin, {Frances R.} and Nunes, {Edward V.} and Shoptaw, {Steven J.} and Trivedi, {Madhukar H.}",
note = "Funding Information: The parent study (ADAPT-2) was supported by awards from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health [ UG1DA020024 (Lead Investigator Dr. Trivedi; Drs. Trivedi and Shoptaw are now MPIs on UG1DA020024 ), UG1DA013035 (to Dr. Nunes), UG1DA040316 , UG1DA013727 , and UG1DA015815 ] and from the Department of Health and Human Services under contract numbers HHSN271201500065C (Clinical Coordinating Center, the Emmes Company) and HHSN271201400028C (Data and Statistics Center, the Emmes Company). Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free-of-charge for use in this trial under a written agreement with NIDA. Dr. Kidd{\textquoteright}s participation was supported by a grant from National Institute on Alcohol Abuse and Alcoholism ( K23AA028296 ). Dr. Smiley acknowledges support from NIDA ( UG1DA020024 ), the Tobacco-Related Disease Research Program ( T31RP2083 , T32SR5041 ), the California HIV/AIDS Research Program ( H21PC3601 ), and the National Institute on Mental Health ( P30 MH058107 ). Dr. Shoptaw acknowledges support from the National Institute on Mental Health ( P30 MH058107 ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH, TRDRP, and CHRP. Funding Information: The parent study (ADAPT-2) was supported by awards from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health [UG1DA020024 (Lead Investigator Dr. Trivedi; Drs. Trivedi and Shoptaw are now MPIs on UG1DA020024), UG1DA013035 (to Dr. Nunes), UG1DA040316, UG1DA013727, and UG1DA015815] and from the Department of Health and Human Services under contract numbers HHSN271201500065C (Clinical Coordinating Center, the Emmes Company) and HHSN271201400028C (Data and Statistics Center, the Emmes Company). Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free-of-charge for use in this trial under a written agreement with NIDA. Dr. Kidd's participation was supported by a grant from National Institute on Alcohol Abuse and Alcoholism (K23AA028296). Dr. Smiley acknowledges support from NIDA (UG1DA020024), the Tobacco-Related Disease Research Program (T31RP2083, T32SR5041), the California HIV/AIDS Research Program (H21PC3601), and the National Institute on Mental Health (P30 MH058107). Dr. Shoptaw acknowledges support from the National Institute on Mental Health (P30 MH058107). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH, TRDRP, and CHRP. Publisher Copyright: {\textcopyright} 2023 Elsevier B.V.",
year = "2023",
month = sep,
day = "1",
doi = "10.1016/j.drugalcdep.2023.110899",
language = "English (US)",
volume = "250",
journal = "Drug and Alcohol Dependence",
issn = "0376-8716",
publisher = "Elsevier Ireland Ltd",
}