Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV, AIDS, Opioid Dependence, Drug Dependence

In brief

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.

Key facts

Study ID

NCT01246401

Run by

Yale University

People needed

151

Starts

2011-03-01

Expected to finish

2016-07-01

Last updated by the study team

2020-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Meets DSM-IV criteria for opioid dependence
• Age > 18 years
• Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
• Within the Connecticut Department of Corrections (CTDOC) or Hampden County Correctional Center (HCCC) and within 30 days of being released to the greater New Haven, Hartford or Springfield areas or within 30 days after release from CTDOC or HCCC.
• No participation in pharmacotherapy trial in the previous 30 days
• Not pregnant

You may not qualify if…

• Unable to provide informed consent
• Verbally or physically threatening to research staff
• Unable to communicate in either English or Spanish
• Pending trials for a felony
• Liver failure (Childs-Pugh Class B or C Cirrhosis)
• Grade IV Hepatitis (liver function tests > 10X normal)
• Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
• Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency
• Active opioid withdrawal (within 3-5 days since last opioid ingestion)
• Pregnancy or unwilling to take contraceptives measures
• Breast-feeding

Where it is running

• Yale University — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Baystate Medical Center — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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