Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) National Development and Research Institutes, Inc. Western Michigan University New York City Department of Health and Mental Hygiene |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00367302 |
The purpose of the study is 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.
Condition | Intervention | Phase |
---|---|---|
Opiate Addiction |
Drug: buprenorphine Drug: methadone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release |
Enrollment: | 116 |
Study Start Date: | August 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Buprenorphine maintenance
|
Drug: buprenorphine
maintenance
|
2: Active Comparator
Methadone maintenance
|
Drug: methadone
maintenance
|
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:
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Stephen Magura, Ph.D. | Western Michigan University |
Responsible Party: | Western Michigan University ( Stephen Magura, Principal Investigator ) |
Study ID Numbers: | DA020583, 1 R21 DA020583 |
Study First Received: | August 21, 2006 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00367302 |
Health Authority: | United States: Federal Government |
addiction jail opiates buprenorphine clinical trial |
Methadone Buprenorphine Behavior, Addictive Mental Disorders |
Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders |
Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |