Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02330419

Collaborator

San Francisco Department of Public Health (Other), National Institutes of Health (NIH) (NIH)

120

Enrollment

Location

Arms

69.1

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Binge Drinking HIV	Drug: Placebo Drug: Naltrexone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo 50mg, as needed	Drug: Placebo
Active Comparator: Naltrexone Naltrexone 50mg, as needed	Drug: Naltrexone

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo 50mg, as needed

Drug: Placebo

Active Comparator: Naltrexone

Naltrexone 50mg, as needed

Drug: Naltrexone

Outcome Measures

Primary Outcome Measures

Efficacy of targeted naltrexone versus placebo in reducing binge drinking among non-dependent MSM [12 weeks]
Number of binge drinking days in timeline follow-back (TLFB), by arm
Efficacy of targeted naltrexone versus placebo in reducing alcohol consumption among non-dependent MSM [12 weeks]
Proportion of ethyl glucuronide (EtG) positive urines, by arm
Efficacy of targeted naltrexone versus placebo in reducing alcohol-associated sexual risk behaviors [12 weeks]
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
Tolerability of targeted naltrexone versus placebo [12 weeks]
Adverse clinical event rates, by arm
Acceptability of targeted naltrexone versus placebo [12 weeks]
Medication adherence (via data from MEMs cap and self-report from SMS texts and TLFB), by arm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center on Substance Use and Health	San Francisco	California	United States	94102

Sponsors and Collaborators

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

Investigators

Principal Investigator: Glenn-Milo Santos, PhD, San Francisco Department of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT02330419

Other Study ID Numbers:

1DP5OD019809
1DP5OD019809

First Posted:

Jan 5, 2015

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Keywords provided by University of California, San Francisco

Naltrexone

Additional relevant MeSH terms:

Binge Drinking

Naltrexone

Study Results

No Results Posted as of Sep 28, 2021