A Phase 2 interventional study of Placebo and Naltrexone in Binge Drinking and HIV, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment
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.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo 50mg, as needed
Drug: Placebo · Behavioral: Medical Management (MM) counseling for alcohol use: · Diagnostic Test: Urinalysis for novel alcohol biochemical markers: · Behavioral: Behavioral survey measurements: · Diagnostic Test: Dried Blood Spot (DSB) Testing for Phosphatidylethanol · Behavioral: Ecological Momentary Assessment
Naltrexone 50mg, as needed
Drug: Naltrexone · Behavioral: Medical Management (MM) counseling for alcohol use: · Diagnostic Test: Urinalysis for novel alcohol biochemical markers: · Behavioral: Behavioral survey measurements: · Diagnostic Test: Dried Blood Spot (DSB) Testing for Phosphatidylethanol · Behavioral: Ecological Momentary Assessment
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.
Also known as: REVIA
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
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).
Also known as: Ethyl glucuronide
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
Also known as: ACASI
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
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
Participants were recruited via street outreach, recruitment flyers, sexual health clinics, needle exchanges, community organizations, bars, websites, and social media in San Francisco Bay Area.
| Milestone | Placebo | Naltrexone |
|---|---|---|
| Started | 60 | 60 |
| Completed | 57 | 53 |
| Not completed | 3 | 7 |
| Withdrew: Lost to follow-up | 3 | 7 |
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.
| days per week | Targeted Naltrexone/Placebo |
|---|---|
| Naltrexone Arm | 1.056 ± 1.522 |
| Placebo Arm | 1.722 ± 1.698 |
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.
| Participants | Targeted Naltrexone/Placebo |
|---|---|
| Targeted Naltrexone | 23 |
| Placebo | 29 |
This outcome measure determines the mean number of male anal sex partners among non-dependent MSM randomized to targeted naltrexone and placebo arms.
| sex partners | Targeted Naltrexone/Placebo |
|---|---|
| Targeted Naltrexone | 1.06 ± 1.41 |
| Placebo | 1.98 ± 3.59 |
This outcome measure determines the mean number of unprotected anal sex partners while intoxicated with alcohol among targeted naltrexone and placebo arms .
| partners | Targeted Naltrexone/Placebo |
|---|---|
| Targeted Naltrexone | 0.96 ± 1.52 |
| Placebo | 0.56 ± 0.95 |
This outcome measure determines the mean number of HIV-serodiscordant unprotected anal sex partners among the targeted naltrexone and placebo arms.
| partners | Targeted Naltrexone/Placebo |
|---|---|
| Targeted Naltrexone | 0.28 ± 0.45 |
| Placebo | 0.26 ± 0.44 |
This outcome measure determines the mean number of unprotected anal sex events with serodiscordant partners
| events | Targeted Naltrexone/Placebo |
|---|---|
| Targeted Naltrexone | 0.81 ± 2.0 |
| Placebo | 0.41 ± 0.92 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/60 (0%) | 1/60 (1.7%) | 20/60 (33.3%) |
| Naltrexone | 0/60 (0%) | 1/60 (1.7%) | 43/60 (71.7%) |
| Event | Placebo | Naltrexone |
|---|---|---|
| bowel obstructionsGastrointestinal disorders | 1/60 | 0/60 |
| soft-tissue infectionMusculoskeletal and connective tissue disorders | 0/60 | 1/60 |
| Event | Placebo | Naltrexone |
|---|---|---|
| nauseaGastrointestinal disorders | 4/60 | 14/60 |
| hyperglycemiaRenal and urinary disorders | 9/60 | 8/60 |
| headacheVascular disorders | 2/60 | 7/60 |
| increased ASTHepatobiliary disorders | 2/60 | 6/60 |
| increased ALTHepatobiliary disorders | 3/60 | 5/60 |
| rashGeneral disorders | 0/60 | 3/60 |
| diarrheaMetabolism and nutrition disorders | 0/60 | 3/60 |
| Age, Continuous(years) | Placebo | Naltrexone | Total |
|---|---|---|---|
| Median | 34 (30 to 42) | 38 (30 to 50) | 37 (30 to 45) |
| Sex/Gender, Customized(Participants) | Placebo | Naltrexone | Total |
|---|---|---|---|
| Gender Identity — Cis-gender male | 59 | 60 | 119 |
| Gender Identity — Transgender male (female to male) | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Placebo | Naltrexone | Total |
|---|---|---|---|
| White | 32 | 33 | 65 |
| Asian | 4 | 2 | 6 |
| Black | 5 | 12 | 17 |
| Latino | 10 | 2 | 12 |
| Other | 9 | 11 | 20 |
| Region of Enrollment(Participants) | Placebo | Naltrexone | Total |
|---|---|---|---|
| United States | 60 | 60 | 120 |
| Education(Participants) | Placebo | Naltrexone | Total |
|---|---|---|---|
| high school or less | 6 | 7 | 13 |
| some college | 19 | 17 | 36 |
| college or above | 35 | 36 | 71 |
| Income(Participants) | Placebo | Naltrexone | Total |
|---|---|---|---|
| under $20,000 | 13 | 16 | 29 |
| $20 - 39,999 | 17 | 12 | 29 |
| $40,000 and above | 30 | 32 | 62 |
| Employment(Participants) | Placebo | Naltrexone | Total |
|---|---|---|---|
| not employed | 14 | 21 | 35 |
| full-time | 29 | 28 | 57 |
| part-time | 12 | 9 | 21 |
| employed student | 5 | 2 | 7 |
| Ever hospitalized for alcohol problem(Participants) | Placebo | Naltrexone | Total |
|---|---|---|---|
| No | 54 | 50 | 104 |
| Yes | 6 | 10 | 16 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2015 to primary completion in Jan 2021, 69 months.
Results were first posted in Apr 2025, 4 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Naltrexone
University of California, San Francisco →