Alcohol Pharmacotherapy for HIV+ Prisoners (INSPIRE)

• log10 HIV-1 RNA levels (copies/mL) [ Time Frame: Baseline, and every 3 months for 1 year ] [ Designated as safety issue: No ]
  Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additional labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels.
  
  
• CD4 cell count (cells/mL) [ Time Frame: Baseline and every 3 months for 1 year ] [ Designated as safety issue: No ]
  Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additionally, blood will be drawn every 3 months for 1 year to monitor changes in CD4 cell count.
  
  

• Alcohol treatment outcome: time to alcohol relapse [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  
• Alcohol treatment outcome: lower percent days drinking [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  
• Alcohol treatment outcome: higher percent days abstinent [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  
• Alcohol treatment outcome: lower addiction severity [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  
• Alcohol treatment outcome: lower craving for alcohol [ Time Frame: 12 weeks prior to release from prison (baseline), day of release, then every month until 12 months post-release ] [ Designated as safety issue: No ]
  

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.