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

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 the community. HIV treatment outcomes (HIV-1 RNA levels, CD4 count,
Highly Active Antiretroviral Therapy (HAART) adherence, retention in care), substance abuse
(time to relapse to opioid use, % opioid negative urines, opioid craving), adverse side
effects and HIV risk behavior (sexual and drug-related risks) outcomes will be compared in
150 recruited prisoners and jail detainees in Connecticut (CT) and Massachusetts (MA) who
will be randomized 2:1 to either XR-NTX or placebo. The primary outcome of interest will be
the proportion with a HIV-RNA <400 copies/mL at 6 months. Secondary outcomes include mean
CD4 count, antiretroviral adherence, retention on HAART and in HIV care, HIV risk behaviors,
time-to-relapse to opioid use, percent opioid negative urines, retention on d-NTX and HIV
quality of life. Primary and secondary outcomes will be assessed for an additional 6 months
after completion of the intervention. If this placebo-controlled trial of XR-NTX among
released HIV+ criminal justice system (CJS) persons with opioid dependence demonstrates
efficacy and safety, it is likely to become an evidence-based intervention to intervene with
this extremely marginalized population in a way that will meet Healthy People 2010's goals
to increase the quality and years of life, decrease health disparities particularly among
minorities, break the cycle of addiction, reduce the numbers of people within the CJS and
launch a number of new and innovative trials and second generation questions for future
research. As such, the individual, our health care system and society have a high likelihood
to benefit. This will not only be true for strategies here in the U.S., but may have even
greater application for geographic areas where the interface between opioid disorders and
HIV is even greater.

Inclusion Criteria:

1. Meets DSM-IV criteria for opioid dependence

2. Age > 18 years

3. Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA
level.

4. 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.

5. No participation in pharmacotherapy trial in the previous 30 days

6. Not pregnant

Exclusion Criteria:

1. Unable to provide informed consent

2. Verbally or physically threatening to research staff

3. Unable to communicate in either English or Spanish

4. Pending trials for a felony

5. Liver failure (Childs-Pugh Class B or C Cirrhosis)

6. Grade IV Hepatitis (liver function tests > 10X normal)

7. Receiving opioid prescription narcotics or has pain syndrome necessitating future use
of opioid prescription narcotics.

8. Receiving active methadone or buprenorphine/naloxone for the treatment of opioid
dependency

9. Active opioid withdrawal (within 3-5 days since last opioid ingestion)

10. Pregnancy or unwilling to take contraceptives measures

11. Breast-feeding