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

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ClinicalTrials.gov Identifier: NCT02330419
Recruitment Status : Completed
First Posted : January 5, 2015
Last Update Posted : September 28, 2021
Sponsor:
Collaborators:
San Francisco Department of Public Health
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE December 30, 2014
First Posted Date  ICMJE January 5, 2015
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
  • Efficacy of targeted naltrexone versus placebo in reducing binge drinking among non-dependent MSM [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Proportion of ethyl glucuronide (EtG) positive urines, by arm
  • Efficacy of targeted naltrexone versus placebo in reducing alcohol-associated sexual risk behaviors [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Adverse clinical event rates, by arm
  • Acceptability of targeted naltrexone versus placebo [ Time Frame: 12 weeks ]
    Medication adherence (via data from MEMs cap and self-report from SMS texts and TLFB), by arm
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
  • Efficacy of targeted naltrexone versus placebo in reducing binge drinking among non-dependent MSM [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Proportion of ethyl glucuronide (EtG) positive urines, by arm
  • Efficacy of targeted naltrexone versus placebo in reducing alcohol-associated sexual risk behaviors [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Adverse clinical event rates, by arm
  • Acceptability of targeted naltrexone versus placebo [ Time Frame: 12 weeks ]
    Medication adherence (via data from WisePill dispenser monitoring and self-report from SMS texts and TLFB), by arm
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM
Official Title  ICMJE Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge Drinking
  • HIV
Intervention  ICMJE
  • Drug: Placebo
  • Drug: Naltrexone
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo 50mg, as needed
    Intervention: Drug: Placebo
  • Active Comparator: Naltrexone
    Naltrexone 50mg, as needed
    Intervention: Drug: Naltrexone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2021
Actual Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02330419
Other Study ID Numbers  ICMJE 1DP5OD019809( U.S. NIH Grant/Contract )
1DP5OD019809 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of California, San Francisco
Original Responsible Party Glenn-Milo Santos, University of California, San Francisco, Research Scientist
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • San Francisco Department of Public Health
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Glenn-Milo Santos, PhD San Francisco Department of Public Health
PRS Account University of California, San Francisco
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP