Alcohol Pharmacotherapy for HIV+ Prisoners

Completed · Not applicable · Has a placebo group

Conditions studied: Alcohol Dependence, Problem Drinking, Hazardous Drinking, Human Immunodeficiency Virus, AIDS

In brief

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.

Key facts

Study ID: NCT01077310
Run by: Yale University
People needed: 100
Starts: 2010-08-01
Expected to finish: 2015-08-01
Last updated by the study team: 2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Yale Clinical Research — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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