Feasibility, acceptability, and tolerability of targeted naltrexone for nondependent methamphetamine-using and binge-drinking men who have sex with men

Glenn Milo Santos, Phillip Coffin, Deirdre Santos, Shannon Huffaker, Tim Matheson, Jason Euren, Anna DeMartini, Christopher Rowe, Judith A. Hahn, David Vlahov, Eric Vittinghoff, Steven L. Batki

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Background: There are no effective pharmacologic strategies for nondependent methamphetamine (meth)-using and binge-drinking men who have sex with men (MSM) at high-risk for HIV. We sought to determine the feasibility of enrolling and retaining this population in a pharmacologic trial; the acceptability of pharmacotherapy study procedures; and the tolerability of targeted naltrexone versus placebo. Methods: Thirty meth-using and binge-drinking MSM were randomly assigned 1:1 to 50 mg naltrexone or placebo for 8 weeks for targeted administration (ie, during craving or in anticipation of meth or alcohol use). Substance use counseling and behavioral assessments were conducted every 2 weeks. Medication use was measured using WisePill dispensers. Results: Trial completion was 93%; visit completion rate was 95%. Mean weekly number of medication pills taken was 2.1 and was similar between arms. Participant satisfaction rate was 96%. There were neither serious adverse events nor differences in adverse event rates between arms. In exploratory intention-to-treat analyses, there were no differences in meth use and drinking. Naltrexone participants had greater reductions in serodiscordant receptive anal intercourse [incident rate ratio (IRR) = 0.15; 95% CI = 0.05 to 0.42] and serodiscordant condomless receptive anal intercourse (IRR = 0.11; 95% CI = 0.03 to 0.37), compared with placebo. In subgroup analyses among frequent meth users, naltrexone participants had greater reductions in meth-using days (IRR = 0.78; 95% CI = 0.62 to 0.99). In as-treated analyses, frequent study medication users in the naltrexone arm had greater reductions in binge drinking days (IRR = 0.72; 95% CI = 0.54 to 0.97). Conclusions: Targeted naltrexone is a feasible, acceptable, and tolerable intervention strategy for nondependent meth-using and binge-drinking MSM. Naltrexone was associated with significant sexual risk reductions; and for some individuals, naltrexone was associated with meth and binge-drinking reductions.

    Original languageEnglish (US)
    Pages (from-to)21-30
    Number of pages10
    JournalJournal of acquired immune deficiency syndromes
    Volume72
    Issue number1
    DOIs
    StatePublished - May 1 2016

    Keywords

    • Alcohol
    • Ethamphetamine
    • HIV
    • HIV prevention
    • Men who have sex with men
    • Pharmacotherapy

    ASJC Scopus subject areas

    • Infectious Diseases
    • Pharmacology (medical)

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