Alcohol Pharmacotherapy for HIV+ Prisoners

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 lower changes in log10
HIV-1 RNA levels, higher CD4 counts and higher rates of retention in care.

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

iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the
control group.

iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to
the community.

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