Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
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|ClinicalTrials.gov Identifier: NCT00367302|
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : May 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Opiate Addiction||Drug: buprenorphine Drug: methadone||Phase 1 Phase 2|
Background: Heroin and other opioid abuse continues as a significant problem among the criminal justice population. In 2002, the criminal justice system was the source of referral for 36% of all substance abuse treatment admissions, the largest source of referrals. Heroin use among offenders has serious health and social consequences. Injection, still the primary route of administration among heroin users, is strongly associated with the transmission of HIV, hepatitis C and other blood-borne diseases. During 1997, 20% to 26% of all people living with HIV in the United States, and 29% to 43% of all those infected with hepatitis C, passed through a correctional facility. The relationship between heroin use and criminal activity has been extensively documented. Although methadone maintenance has been the primary treatment for chronic opioid dependence since the 1970's, correctional systems in the U.S., with very few exceptions (primarily Rikers Island in New York City), have not provided institutional access to methadone maintenance. Regrettably, negative attitudes to methadone are prevalent among criminal justice professionals, the public, treatment providers and opioid-dependent offenders themselves; there is little prospect of that changing soon. Buprenorphine maintenance is a recently approved therapy that may be more acceptable than methadone to the criminal justice system and opioid-dependent offenders. With one minor exception, buprenorphine has never been systematically administered as an opioid replacement therapy in a correctional setting in the U.S.
Aims and Objectives:
- To determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release.
- To conduct a randomized clinical trial of buprenorphine maintenance (N=50) vs. methadone maintenance (N=50) initiated in the jail setting and continuing in the community.
- To determine the reasons that offenders fail to report for community buprenorphine or methadone treatment after release or drop out of community treatment.
Study Design: Consenting eligible inmates at Rikers Island in New York City will be randomly assigned to buprenorphine or methadone maintenance in jail and will be referred to a corresponding community treatment upon their release. Subjects will be followed-up at 3 months after release from jail.
Target Population: Opioid-dependent jail inmates sentenced to 10- 90 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release|
|Study Start Date :||August 2006|
|Primary Completion Date :||January 2008|
|Study Completion Date :||January 2008|
Other Name: Suboxone
Active Comparator: 2
- Treatment completion in jail [ Time Frame: Until release from jail ]
- Reporting to assigned treatment modality after release [ Time Frame: Within 3 months after release from jail ]
- Intention to continue treatment after release [ Time Frame: At release from jail ]
- Re-incarceration [ Time Frame: Within 3 months after release ]
- Frequency of illicit opioid use after release [ Time Frame: Within 3 months after release ]
- Re-arrest [ Time Frame: Within 3 months after release ]
- Severity of re-arrest charges [ Time Frame: Within 3 months after release, if re-arrested ]
- Satisfaction with opioid replacement treatment. [ Time Frame: During jail and 3 months post-release ]
- Opioid withdrawal symptoms and cravings [ Time Frame: During jail and post-release ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367302
|Principal Investigator:||Stephen Magura, Ph.D.||Western Michigan University|