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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: HIV; Binge Drinking

Treatments: Diagnostic Test: Urinalysis for novel alcohol biochemical markers:; Behavioral: Behavioral survey measurements:; Behavioral: Medical Management (MM) counseling for alcohol use:; Drug: Placebo; Behavioral: Ecological Momentary Assessment; Diagnostic Test: Dried Blood Spot (DSB) Testing for Phosphatidylethanol; Drug: Naltrexone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02330419

1DP5OD019809 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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 < 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo 50mg, as needed

Treatment:

Behavioral: Ecological Momentary Assessment

Diagnostic Test: Dried Blood Spot (DSB) Testing for Phosphatidylethanol

Drug: Placebo

Behavioral: Medical Management (MM) counseling for alcohol use:

Behavioral: Behavioral survey measurements:

Diagnostic Test: Urinalysis for novel alcohol biochemical markers:

Naltrexone

Active Comparator group

Description:

Naltrexone 50mg, as needed

Treatment:

Drug: Naltrexone

Behavioral: Ecological Momentary Assessment

Diagnostic Test: Dried Blood Spot (DSB) Testing for Phosphatidylethanol

Behavioral: Medical Management (MM) counseling for alcohol use:

Behavioral: Behavioral survey measurements:

Diagnostic Test: Urinalysis for novel alcohol biochemical markers: