Phase 2
N=120
Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)
Binge Drinking · HIV
Bottom Line
View on ClinicalTrials.gov: NCT02330419 ↗Enrolled (actual)
120
Serious AEs
1.7%
Results posted
Apr 2025
Primary outcome: Primary: Binge Drinking Days Per Week — 1.056; 1.722 days per week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Naltrexone (Drug); Medical Management (MM) counseling for alcohol use: (Behavioral); Urinalysis for novel alcohol biochemical markers: (Diagnostic_test); Behavioral survey measurements: (Behavioral); Dried Blood Spot (DSB) Testing for Phosphatidylethanol (Diagnostic_test); Ecological Momentary Assessment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binge Drinking Days Per Week |
1.056; 1.722 | — |
| PRIMARY Positive Ethyl Glucuronide (EtG) Tests |
23; 29 | — |
| PRIMARY Male Anal Sex Partners |
1.06; 1.98 | — |
| PRIMARY Unprotected Anal Sex Partners While Intoxicated With Alcohol |
0.96; 0.56 | — |
| PRIMARY HIV-serodiscordant Unprotected Anal Sex Partners |
0.28; 0.26 | — |
| PRIMARY Unprotected Anal Sex Events With Serodiscordant Partners |
0.81; 0.41 | — |
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.
Eligibility Criteria
Inclusion Criteria
- (1) Male gender (2) self-reported anal sex with men in the prior three months while under the influence of alcohol (3) at least one binge drinking (five or more drinks on a single occasion) session per week in the prior three months; (4) interested in reducing binge alcohol consumption; (5) HIV-negative by rapid antibody test or medical record documentation of HIV infection (HIV positive participants); (6) no current acute illnesses requiring prolonged medical care; (7) no chronic illnesses that are likely to progress clinically during trial participation; (8) able and willing to provide informed consent and adhere to visit schedule; (9) age 18-70 years; (10) baseline complete blood count (CBC), total protein, albumin, glucose, alkaline phosphatase, creatinine, blood urea nitrogen (BUN), and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history.
Exclusion Criteria
- (1) Any psychiatric (e.g. depression with suicidal ideation) or medical condition that would preclude safe participation in the study; (2) known allergy/previous adverse reaction to naltrexone; (3) current use of/ dependence on any opioids or a known medical condition which currently requires/may likely require opioid analgesics; (4) opioid-positive urine at enrollment; (5) current CD4 count 3 times upper limit of normal); (7) impaired renal function (creatinine clearance < 50 ml/min); (8) currently participating in another intervention research study with potential overlap; (9) alcohol dependence as determined by Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) criteria (participants with non-dependent alcohol use disorders/symptoms of alcohol abuse (per Diagnostic and Statistical Manual--DSM-IV) are eligible) (10) any condition that, in the principal investigator and/or study clinician's judgment interferes with safe study participation or adherence to study procedures; (11) not having a cell-phone that can send and receive text messages.
Data sourced from ClinicalTrials.gov (NCT02330419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.