At a glance
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Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
In Brief
A Phase 2 clinical trial evaluating Extended-Release Naltrexone for HIV and 3 related conditions. Completed, enrolled 151 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg