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History of Changes for Study: NCT02330419
The Better THAN Study: Targeting Heavy Alcohol Use With Naltrexone Among MSM (Better THAN)
Latest version (submitted September 27, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 30, 2014 None (earliest Version on record)
2 April 15, 2015 Recruitment Status, Study Status, Study Identification and Contacts/Locations
3 May 4, 2015 Contacts/Locations and Study Status
4 July 13, 2015 Contacts/Locations, Sponsor/Collaborators and Study Status
5 February 24, 2016 Study Status
6 September 28, 2016 Study Status
7 January 5, 2018 Study Status
8 December 10, 2018 Study Status
9 November 14, 2019 Study Status
10 September 10, 2020 Recruitment Status, Study Status, Contacts/Locations and Outcome Measures
11 January 19, 2021 Recruitment Status, Study Status and Study Design
12 September 27, 2021 Study Status
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Study NCT02330419
Submitted Date:  December 30, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1DP5OD019809
Brief Title: The Better THAN Study: Targeting Heavy Alcohol Use With Naltrexone Among MSM (Better THAN)
Official Title: The Better THAN Study: Targeting Heavy Alcohol Use With Naltrexone Among MSM
Secondary IDs: 1DP5OD019809 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: December 2014
Overall Status: Not yet recruiting
Study Start: February 2015
Primary Completion: August 2018 [Anticipated]
Study Completion: February 2019 [Anticipated]
First Submitted: December 30, 2014
First Submitted that
Met QC Criteria:
December 30, 2014
First Posted: January 5, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 30, 2014
Last Update Posted: January 5, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of California, San Francisco
Responsible Party: Principal Investigator
Investigator: Glenn-Milo Santos
Official Title: Research Scientist
Affiliation: University of California, San Francisco
Collaborators: San Francisco Department of Public Health
National Institutes of Health (NIH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Binge Drinking
HIV
Keywords: Naltrexone
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo 50mg, as needed
Drug: Placebo
Active Comparator: Naltrexone
Naltrexone 50mg, as needed
Drug: Naltrexone
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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
3. 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
4. Tolerability of targeted naltrexone versus placebo
[ Time Frame: 12 weeks ]

Adverse clinical event rates, by arm
5. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: Male
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Jason Euren, MA
Telephone: 415.437.6276
Email: Jason.Euren@sfdph.org
Study Officials: Glenn-Milo Santos, PhD
Principal Investigator
San Francisco Department of Public Health
Locations: United States, California
Substance Use Research Unit
San Francisco, California, United States, 94102
Contact:Contact: Jason Euren, MA 415-437-6276 Jason.Euren@sfdph.org
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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