View Clinical Trial (Medical Research Study)
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06519 |
| Conditions: |
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HIV - AIDS - Opioid Dependence - Drug Dependence |
| Purpose: |
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Specific Aim: To conduct a randomized, placebo-controlled trial of depot-naltrexone (d-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. d-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. d-NTX will result in improved opioid treatment outcomes, including longer time to
opioid relapse, lower addiction severity and lower craving for opioid.
iii. d-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the
control group.
iv. d-NTX will result in decreased rates of reincarceration after 12 months of release to
the community.
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| Study Summary: |
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The specific aim for this study is to conduct a placebo-controlled trail (RCT) of d-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 d-NTX or depot-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 d-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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01246401 |
| Primary Contact: |
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Principal Investigator
Sandra A Springer, MD
Yale University
Angela DiPaola, MS
Phone: 2037375530
Email: angela.dipaola@yale.edu
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| Backup Contact: |
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Email: ruthanne.marcus@yale.edu
Ruthanne Marcus
Phone: 2037649958
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| Location Contact: |
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New Haven, Connecticut 06519
United States
Angela DiPaola, MS
Phone: 203-737-5530
Email: angela.dipaola@yale.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
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