Human Immunodeficiency Virus Clinical Trial
Official title:
Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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