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.
This is a double-blinded, placebo controlled trial of 120 binge-drinking MSM to 12 weeks of naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethically and racially diverse participants will be recruited using venue based recruitment and social network bsed recruitment strategies. Participants 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. Efficacy on alcohol consumption and alcohol-associated sexual risk behavior (Aims 1-3) will be assessed using weekly timeline follow-back, screening for ethyl glucuronide (EtG) positive urines, and computer administered monthly interventions. Tolerability and acceptability (Aim 4) will be assessed through tracking of adverse events and medication adherence. Generalized estimating equation (GEE) models will be fitted to estimate treatment effects on repeated study outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Placebo capsules will contain microcrystalline cellulose (Medisca). Placebo and active medication will be provided in capsules that are an exact match in color, so as to make the placebo and active medication indistinguishable from each other.
REVIA is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. REVIA is available in scored film-coated tablets containing 50 mg of naltrexone hydrochloride.
MM is a low-intensity supportive program designed to increase problem recognition and enhance motivation to change maladaptive alcohol use patterns. Participants will receive individual 20 minute MM sessions weekly from trained staff supervised by a clinical psychologist
Center on Substance Use and Health
San Francisco, California, United States
Binge Drinking Days Per Week
This outcome measure determines the mean number of binge drinking days among participants randomized to targeted naltrexone and placebo arms. The Center for Disease Control (CDC) defines binge drinking as consuming 5 or more drinks on an occasion for men or 4 or more drinks on an occasion for women.
Time frame: 12 weeks
Positive Ethyl Glucuronide (EtG) Tests
This outcome measure determines the number of participants with positive ethyl glucuronide tests among non-dependent MSM who were randomized to targeted naltrexone and placebo arms. Ethyl glucuronide (EtG) is a non-volatile, water-soluble, stable, direct metabolite of ethanol that can be detected in urine for 48 hours or sometimes 72 hours after drinking if there is heavy drinking.
Time frame: 12 weeks
Male Anal Sex Partners
This outcome measure determines the mean number of male anal sex partners among non-dependent MSM randomized to targeted naltrexone and placebo arms.
Time frame: 12 weeks
Unprotected Anal Sex Partners While Intoxicated With Alcohol
This outcome measure determines the mean number of unprotected anal sex partners while intoxicated with alcohol among targeted naltrexone and placebo arms .
Time frame: 12 weeks
HIV-serodiscordant Unprotected Anal Sex Partners
This outcome measure determines the mean number of HIV-serodiscordant unprotected anal sex partners among the targeted naltrexone and placebo arms.
Time frame: 12 weeks
Unprotected Anal Sex Events With Serodiscordant Partners
This outcome measure determines the mean number of unprotected anal sex events with serodiscordant partners
Time frame: 12 weeks
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Urine samples will be collected weekly and tested for ethyl glucuronide (EtG) to determine recent alcohol consumption. EtG is a relatively novel, highly sensitive indicator for recent alcohol consumption; this alcohol biomarker is detectable in urine for approximately 72 hours).
Standardized and validated behavioral measure that will be assessed using audio computer administered surveys (ACASI) to minimize underreporting of risk activities and standardize data collection
Phosphatidylethanol (PEth)-a phospholipid formed only in the presence of alcohol-is a novel, direct biochemical marker of alcohol that has shown high (\>95%) sensitivity and specificity to detect heavy drinking over a period of 2-3 weeks in several studies of dependent patients and abstainers. DSB samples will be collected at enrollment, weeks 3, 6, 9, 12, and post-treatment visits at month 1, 3, and 6.
Ecological Momentary Assessments are SMS texts to collect data on alcohol consumption, number of drinks on drinking days, and targeted medication administration prior to anticipated drinking sessions. Messages will use short-hand notations to maintain participant confidentiality