Feasibility, Acceptability & Tolerability of Targeted Naltrexone for Non-Dependent Methamphetamine-Using & Binge-Drinking Men Who Have Sex with Men

BACKGROUND:

There are no effective pharmacologic strategies for non-dependent methamphetamine (meth)-using and binge-drinking 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 50mg naltrexone or placebo for 8 weeks for targeted administration (i.e., during craving or in anticipation of meth or alcohol use). Substance use counseling and behavioral assessments were conducted every two 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 2.2 and was similar between arms. Participant satisfaction rate was 96%. There were no 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 (IRR=0.15; 95%CI=0.05-0.42) and serodiscordant condomless receptive anal intercourse (IRR=0.11; 95%CI=0.03-0.37), compared to placebo. In subgroup analyses among frequent meth-users, naltrexone participants had greater reductions in meth-using days (IRR=0.78; 95%CI=0.62-0.99). In as-treated analyses, frequent study medication users in the naltrexone arm had greater reductions in binge drinking days (IRR=0.72; 95%CI=0.54-0.97).

CONCLUSIONS:

Targeted naltrexone is a feasible, acceptable and tolerable intervention strategy for non-dependent 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.

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By:   Santos GM1, Coffin P, Santos D, Huffaker S, Matheson T, Euren J, DeMartini A, Rowe C, Hahn JA, Vlahov D, Vittinghoff E, Batki SL.

• 1Center for Public Health Research Branch, San Francisco Department of Public Health 2University of California San Francisco, School of Nursing, Department of Community Health Systems 3University of California San Francisco, School of Medicine, Division of HIV/AIDS 4University of California San Francisco, School of Medicine, Department of Medicine 5University of California San Francisco, School of Medicine, Department of Epidemiology and Biostatistics 6University of California San Francisco, School of Medicine, Department of Psychiatry 7San Francisco Veterans Affairs Medical Center. 

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