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

NCT02330419 | Completed Phase 2 Results DMC

• 1 other identifier: 1DP5OD019809
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Binge Drinking; HIV

Keywords

Naltrexone

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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 .

  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.

  12 weeks

• Unprotected Anal Sex Events With Serodiscordant Partners

  This outcome measure determines the mean number of unprotected anal sex events with serodiscordant partners

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

Placebo DRUG

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.

Placebo

Naltrexone DRUG

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

Naltrexone

Medical Management (MM) counseling for alcohol use: BEHAVIORAL

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

Naltrexone; Placebo

Urinalysis for novel alcohol biochemical markers: DIAGNOSTIC_TEST

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

Naltrexone; Placebo

Behavioral survey measurements: BEHAVIORAL

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

Naltrexone; Placebo

Dried Blood Spot (DSB) Testing for Phosphatidylethanol DIAGNOSTIC_TEST

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.

Naltrexone; Placebo

Ecological Momentary Assessment BEHAVIORAL

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

Naltrexone; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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 \< 200 cells/mm3 (6) moderate/severe liver disease (aspartate aminotransferase (AST), alanine transaminase (ALT) \> 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Department of Public Health: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Center on Substance Use and Health

San Francisco, California, 94102, United States

Location

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MeSH Terms

Conditions

Binge Drinking

Interventions

Naltrexone; Counseling; Ethanol; Urinalysis; Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Alcohols; Organic Chemicals; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques; Psychological Tests

Limitations and Caveats

Future studies outside the San Francisco Bay Area and inclusive of other populations with mild to moderate AUD may be needed to examine the potential of targeted naltrexone more broadly. Our self-reported alcohol measures may be subject to bias. However, these measures have been validated and we have used ACASI to further enhance the validity of our self-reported measures. There is evidence that collecting alcohol biomarkers can enhance validity of self-report of alcohol use.

Results Point of Contact

• Title: Glenn-Milo Santos, Associate Professor
• Organization: Department of Community Health Systems, University of California at San Francisco

glenn-milo.santos@ucsf.edu

(628) 2177-6231

Study Officials

• Glenn-Milo Santos, PhD

  San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 5, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Locations

US (1)