Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

January 31, 2021

Study Completion Date

January 31, 2021

Conditions
Binge DrinkingHIV
Interventions
DRUG

Placebo

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.

DRUG

Naltrexone

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.

BEHAVIORAL

Medical Management (MM) counseling for alcohol use:

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

DIAGNOSTIC_TEST

Urinalysis for novel alcohol biochemical markers:

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).

BEHAVIORAL

Behavioral survey measurements:

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

DIAGNOSTIC_TEST

Dried Blood Spot (DSB) Testing for Phosphatidylethanol

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.

BEHAVIORAL

Ecological Momentary Assessment

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

Trial Locations (1)

94102

Center on Substance Use and Health, San Francisco

All Listed Sponsors
collaborator

San Francisco Department of Public Health

OTHER_GOV

collaborator

National Institutes of Health (NIH)

NIH

lead

University of California, San Francisco

OTHER

NCT02330419 - Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM) | Biotech Hunter | Biotech Hunter