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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of California, San Francisco
Sponsor:
Collaborators:
San Francisco Department of Public Health
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02330419
First received: December 30, 2014
Last updated: September 28, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Binge Drinking
HIV
Drug: Placebo
Drug: Naltrexone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: April 2015
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo 50mg, as needed
Drug: Placebo
Active Comparator: Naltrexone
Naltrexone 50mg, as needed
Drug: Naltrexone

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02330419

Contacts
Contact: Jaclyn Hern, MPH 415.437.6276 Jaclyn.hern@sfdph.org

Locations
United States, California
Substance Use Research Unit Recruiting
San Francisco, California, United States, 94102
Contact: Jaclyn Hern, MPH    415-437-6276    Jaclyn.hern@sfdph.org   
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
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02330419     History of Changes
Other Study ID Numbers: 1DP5OD019809 ( US NIH Grant/Contract Award Number )
Study First Received: December 30, 2014
Last Updated: September 28, 2016

Keywords provided by University of California, San Francisco:
Naltrexone

Additional relevant MeSH terms:
Binge Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol Drinking
Drinking Behavior
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on March 28, 2017