Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
Specific Aim: To conduct a randomized, placebo-controlled trial of extended
release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners
meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are
transitioning from the structure of a correctional setting to the community.
Hypotheses:
i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA
levels, higher CD4 counts and higher rates of retention in care.
ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid
relapse, lower addiction severity and lower craving for opioid.
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Yale University
Collaborators:
Baystate Medical Center National Institute on Drug Abuse (NIDA)