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Binge DrinkingPhase 2SayWhenNCT02330419

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

A Phase 2 study testing Naltrexone, Medical Management (MM) counseling for alcohol use: and Urinalysis for novel alcohol biochemical markers: in people with Binge Drinking and HIV, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Binge Drinking, HIV
What is being tested?
Naltrexone, Medical Management (MM) counseling for alcohol use: and Urinalysis for novel alcohol biochemical markers:
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
Apr 2015to Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • (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.

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center on Substance Use and Health

    San Francisco, California, 94102

Other trials in United States

About this study

Official title: Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among MSM

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.

Read the detailed description

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.

Conditions
Binge Drinking, HIV
Being tested
Placebo, Naltrexone, Medical Management (MM) counseling for alcohol use:, Urinalysis for novel alcohol biochemical markers:, Behavioral survey measurements:
Keywords
Naltrexone
Medical subject headings
Binge Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    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.

  • NaltrexoneDrug

    Also called REVIA

    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.

  • Medical Management (MM) counseling for alcohol use:Behavioural

    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

  • Urinalysis for novel alcohol biochemical markers:Diagnostic test

    Also called Ethyl glucuronide

    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 survey measurements:Behavioural

    Also called ACASI

    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

  • Dried Blood Spot (DSB) Testing for PhosphatidylethanolDiagnostic 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.

  • Ecological Momentary AssessmentBehavioural

    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

Study groups in NCT02330419
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo 50mg, as needed
Receives: 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
NaltrexoneActive comparatorNaltrexone 50mg, as needed
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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 .

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

  6. Unprotected Anal Sex Events With Serodiscordant Partners

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJan 2021
  4. Study completionJan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02330419
Sponsor's protocol ID
1DP5OD019809
Other IDs
1DP5OD019809
Acronym
SayWhen
Status last verified
Apr 2025
First submitted
30 Dec 2014
Last updated
20 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
No

Publications

  • Finlayson TJ, Le B, Smith A, Bowles K, Cribbin M, Miles I, Oster AM, Martin T, Edwards A, Dinenno E; Centers for Disease Control and Prevention (CDC). HIV risk, prevention, and testing behaviors among men who have sex with men--National HIV Behavioral Surveillance System, 21 U.S. cities, United States, 2008. MMWR Surveill Summ. 2011 Oct 28;60(14):1-34.

    PubMed 22031280

  • Centers for Disease Control and Prevention (CDC). Vital signs: binge drinking prevalence, frequency, and intensity among adults - United States, 2010. MMWR Morb Mortal Wkly Rep. 2012 Jan 13;61(1):14-9.

    PubMed 22237031

  • Stall R, Paul JP, Greenwood G, Pollack LM, Bein E, Crosby GM, Mills TC, Binson D, Coates TJ, Catania JA. Alcohol use, drug use and alcohol-related problems among men who have sex with men: the Urban Men's Health Study. Addiction. 2001 Nov;96(11):1589-601. doi: 10.1046/j.1360-0443.2001.961115896.x.

    PubMed 11784456

  • Colfax G, Vittinghoff E, Husnik MJ, McKirnan D, Buchbinder S, Koblin B, Celum C, Chesney M, Huang Y, Mayer K, Bozeman S, Judson FN, Bryant KJ, Coates TJ; EXPLORE Study Team. Substance use and sexual risk: a participant- and episode-level analysis among a cohort of men who have sex with men. Am J Epidemiol. 2004 May 15;159(10):1002-12. doi: 10.1093/aje/kwh135.

    PubMed 15128613

  • Wolitski RJ, Stall R, Valdiserri R. Unequal Opportunity: Health Disparities affecting Gay and Bisexual Men in the United States. New York: Oxford Press; 2008.

  • Raymond HF. San Francisco National HIV Behavioral Surveillance Data - MSM and Binge-drinking. In: Santos GM, ed. San Francisco: San Francisco Department of Public Health; 2012.

  • Raymond HF, Bereknyei S, Berglas N, Hunter J, Ojeda N, McFarland W. Estimating population size, HIV prevalence and HIV incidence among men who have sex with men: a case example of synthesising multiple empirical data sources and methods in San Francisco. Sex Transm Infect. 2013 Aug;89(5):383-7. doi: 10.1136/sextrans-2012-050675. Epub 2013 Apr 25.

    PubMed 23620133

  • Jin H. San Francisco National HIV Behavioral Surveillance Survey Data Request - MSM3 Binge Drinking Data. In: Santos G, ed. San Francisco2014:1.

  • Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker F, Lin LS, An Q, Mermin J, Lansky A, Hall HI; HIV Incidence Surveillance Group. Estimated HIV incidence in the United States, 2006-2009. PLoS One. 2011;6(8):e17502. doi: 10.1371/journal.pone.0017502. Epub 2011 Aug 3.

    PubMed 21826193

  • SFDPH. HIV/AIDS Epidemiology Annual Report. San Francisco San Francisco Department of Public Health 2010.

  • Mansergh G, Koblin BA, McKirnan DJ, Hudson SM, Flores SA, Wiegand RE, Purcell DW, Colfax GN; Project MIX Study Team. An intervention to reduce HIV risk behavior of substance-using men who have sex with men: a two-group randomized trial with a nonrandomized third group. PLoS Med. 2010 Aug 24;7(8):e1000329. doi: 10.1371/journal.pmed.1000329.

    PubMed 20811491

  • Leigh BC. Alcohol and condom use: a meta-analysis of event-level studies. Sex Transm Dis. 2002 Aug;29(8):476-82. doi: 10.1097/00007435-200208000-00008.

    PubMed 12172533

  • Woolf SE, Maisto SA. Alcohol use and risk of HIV infection among men who have sex with men. AIDS Behav. 2009 Aug;13(4):757-82. doi: 10.1007/s10461-007-9354-0. Epub 2008 Jan 31.

    PubMed 18236149

  • Maisto SA, Palfai T, Vanable PA, Heath J, Woolf-King SE. The effects of alcohol and sexual arousal on determinants of sexual risk in men who have sex with men. Arch Sex Behav. 2012 Aug;41(4):971-86. doi: 10.1007/s10508-011-9846-x. Epub 2011 Oct 19.

    PubMed 22009480

  • George WH, Stoner SA. Understanding acute alcohol effects on sexual behavior. Annu Rev Sex Res. 2000;11:92-124.

    PubMed 11351836

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naltrexone, Medical Management (MM) counseling for alcohol use: and Urinalysis for novel alcohol biochemical markers: in people with Binge Drinking and HIV, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binge Drinking Days Per Week (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02330419, which also lists 148 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

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