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Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM (Say When)

Primary Purpose

Binge Drinking, HIV

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Naltrexone
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Drinking focused on measuring Naltrexone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts 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 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.

Sites / Locations

  • Center on Substance Use and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Naltrexone

Arm Description

Placebo 50mg, as needed

Naltrexone 50mg, as needed

Outcomes

Primary Outcome Measures

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
Efficacy of targeted naltrexone versus placebo in reducing alcohol consumption among non-dependent MSM
Proportion of ethyl glucuronide (EtG) positive urines, by arm
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
Tolerability of targeted naltrexone versus placebo
Adverse clinical event rates, by arm
Acceptability of targeted naltrexone versus placebo
Medication adherence (via data from MEMs cap and self-report from SMS texts and TLFB), by arm

Secondary Outcome Measures

Full Information

First Posted
December 30, 2014
Last Updated
September 27, 2021
Sponsor
University of California, San Francisco
Collaborators
San Francisco Department of Public Health, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02330419
Brief Title
Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM
Acronym
Say When
Official Title
Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Department of Public Health, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Drinking, HIV
Keywords
Naltrexone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 50mg, as needed
Arm Title
Naltrexone
Arm Type
Active Comparator
Arm Description
Naltrexone 50mg, as needed
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Primary Outcome Measure Information:
Title
Efficacy of targeted naltrexone versus placebo in reducing binge drinking among non-dependent MSM
Description
Number of binge drinking days in timeline follow-back (TLFB), by arm
Time Frame
12 weeks
Title
Efficacy of targeted naltrexone versus placebo in reducing alcohol consumption among non-dependent MSM
Description
Proportion of ethyl glucuronide (EtG) positive urines, by arm
Time Frame
12 weeks
Title
Efficacy of targeted naltrexone versus placebo in reducing alcohol-associated sexual risk behaviors
Description
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
Time Frame
12 weeks
Title
Tolerability of targeted naltrexone versus placebo
Description
Adverse clinical event rates, by arm
Time Frame
12 weeks
Title
Acceptability of targeted naltrexone versus placebo
Description
Medication adherence (via data from MEMs cap and self-report from SMS texts and TLFB), by arm
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn-Milo Santos, PhD
Organizational Affiliation
San Francisco Department of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Substance Use and Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

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