Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

HIV Clinical Trial

— Say When  

Official title:

Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330419
• Other study ID #: 1DP5OD019809
• Secondary ID: 1DP5OD019809
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: January 2021

Study information

• Verified date: September 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge Drinking
• HIV

Intervention

Drug:
• Placebo

• Naltrexone

Locations

Country	Name	City	State
United States	Center on Substance Use and Health	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institutes of Health (NIH), San Francisco Department of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Tolerability of targeted naltrexone versus placebo	Adverse clinical event rates, by arm	12 weeks
Primary	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