Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

Study Overview
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Brief Summary
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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.

Official Title
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Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

Conditions
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HIV, Binge Drinking

Intervention / Treatment
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* Drug: Placebo
* Drug: Naltrexone


Participation Criteria
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Eligibility Criteria
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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 CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, 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 < 200 cells/mm3 (6) moderate/severe liver disease (AST, 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 SCID criteria (participants with non-dependent alcohol use disorders/symptoms of alcohol abuse [per 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo 50mg, as needed | Drug: Placebo<br> <br> |
| Active Comparator: Naltrexone<br>Naltrexone 50mg, as needed | Drug: Naltrexone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of targeted naltrexone versus placebo in reducing binge drinking among non-dependent MSM | Number of binge drinking days in timeline follow-back (TLFB), by arm | 12 weeks | 
| Efficacy of targeted naltrexone versus placebo in reducing alcohol consumption among non-dependent MSM | Proportion of ethyl glucuronide (EtG) positive urines, by arm | 12 weeks | 
| Efficacy of targeted naltrexone versus placebo in reducing alcohol-associated sexual risk behaviors | GEE Poisson models with robust standard errors for the four monthly ACASI assessments on numbers of male anal sex partners, HIV-serodiscordant unprotected anal sex partners, unprotected anal sex partners while intoxicated with alcohol, and unprotected anal sex events with serodiscordant partners, including the baseline value | 12 weeks | 
| Tolerability of targeted naltrexone versus placebo | Adverse clinical event rates, by arm | 12 weeks | 
| Acceptability of targeted naltrexone versus placebo | Medication adherence (via data from MEMs cap and self-report from SMS texts and TLFB), by arm | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naltrexone