Overview

Alcohol Pharmacotherapy for HIV+ Prisoners

Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Treatments:
Ethanol
Naltrexone
Criteria
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

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