Status:
COMPLETED
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Lead Sponsor:
Yale University
Collaborating Sponsors:
Baystate Medical Center
National Institute on Drug Abuse (NIDA)
Conditions:
HIV
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 Manua...
Detailed Description
The specific aim for this study is to conduct a placebo-controlled trail (RCT) of XR-NTX among HIV+ persons in jails and prisons meeting DSM-IV criteria for opioid dependence who are transitioning to ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01246401
Start Date
March 1 2011
End Date
July 1 2016
Last Update
March 19 2020
Active Locations (3)
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1
Yale University
Hartford, Connecticut, United States, 06106
2
Yale University
New Haven, Connecticut, United States, 06519
3
Baystate Medical Center
Springfield, Massachusetts, United States, 01103