drugset / Trial / NCT02330419
Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)
Phase 2
Completed
120 enrolled
University of California, San Francisco
National Institutes of Health (NIH) · collabSan Francisco Department of Public Health · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially diverse participants will be recruited using Respondent Driven Sampling as well as active field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys will be completed monthly.
Timeline
- Start
- 2015-04
- Primary completion
- 2021-01
- Completion
- 2021-01
Publications
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- Background Coffin PO, Santos GM, Das M, Santos DM, Huffaker S, Matheson T, Gasper J, Vittinghoff E, Colfax GN. Aripiprazole for the treatment of methamphetamine dependence: a randomized, double-blind, placebo-controlled trial. Addiction. 2013 Apr;108(4):751-61. doi: 10.1111/add.12073. Epub 2013 Jan 3.
- Background Coffin PO, Santos GM, Colfax G, Das M, Matheson T, DeMicco E, Dilley J, Vittinghoff E, Raiford JL, Carry M, Herbst JH. Adapted personalized cognitive counseling for episodic substance-using men who have sex with men: a randomized controlled trial. AIDS Behav. 2014 Jul;18(7):1390-400. doi: 10.1007/s10461-014-0712-4.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naltrexone | Small molecule | 50 mg | — |