Alcohol Pharmacotherapy for HIV+ Prisoners

Not Applicable

Completed

• Conditions: Hazardous Drinking; Human Immunodeficiency Virus; AIDS; Alcohol Dependence; Problem Drinking
• Interventions: Drug: Placebo; Drug: Vivitrol- Intramuscular naltrexone (depot-formulation)

• Registration Number: NCT01077310
• Lead Sponsor: Yale University

Brief Summary

This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.

Detailed Description

INSPIRE is a randomized controlled trial of injectable intramuscular NTX (XR-NTX) versus intramuscular placebo among Human Immunodeficiency (HIV) infected prisoners meeting DSM-IV criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. While the COMBINE trial has demonstrated the effectiveness of oral naltrexone in a group of active alcohol dependent persons in decreasing relapse to alcohol use over placebo, naltrexone has not been studied in people who have a history of current alcohol dependence prior to incarceration, are incarcerated and not actively using alcohol and are likely to return to alcohol use when released. In this study, we conduct a placebo-controlled trial to determine if naltrexone has an effect in this group, which could be important in making the case for having naltrexone available to alcohol dependent or problem drinking HIV+ prisoners prior to release. We will compare their HIV treatment (HIV-1 RNA levels, CD4 count), alcohol treatment (time to relapse to heavy drinking, percent of days drinking, percent of days abstinent and alcohol craving) and HIV risk behavior (sexual and drug-related risks) outcomes. The hypotheses include:

i. XR-NTX will result in improved HIV clinical outcomes, including changes in HIV-1 RNA levels, and higher CD4 counts.

ii. XR-NTX will result in improved alcohol treatment outcomes, including longer time to alcohol relapse, lower percent days drinking, and lower craving for alcohol.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-03-01
• Study Start: 2010-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2016-08-04
• Results First Submitted QC: 2016-10-04
• Results First Posted: 2016-11-25
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. HIV+
2. Inmates returning to New Haven or Hartford
3. Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
4. Gives informed consent
5. English or Spanish speaker
6. > 18 yrs

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Exclusion Criteria

1. On opiate pain medication or expressing need for them
2. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 5x the upper limit of normal
3. Evidence of Child's Pugh Class C cirrhosis
4. Pending felony charges
5. Pregnant or unwilling to take contraceptive measures
6. Subject is part of another pharmacological research study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Intramuscular naltrexone	Vivitrol- Intramuscular naltrexone (depot-formulation)	Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.

Primary Outcome Measures

Name	Time	Method
Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL	Baseline to month 6 post release	Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.

Secondary Outcome Measures

Name	Time	Method
Alcohol Treatment Outcome: Time to Alcohol Relapse	Post release	Self reported time to first heavy drinking day after release from incarceration, up to 6 months
Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day	12 weeks prior to release from prison (baseline) to 6 months post release	The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day
Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days	change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release	change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.

Trial Locations

Locations (1)

Yale Clinical Research; 🇺🇸 New Haven, Connecticut, United States