Full Text View
Tabular View
No Study Results Posted
Related Studies
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
This study has been completed.
Study NCT00367302   Information provided by National Institute on Drug Abuse (NIDA)
First Received: August 21, 2006   Last Updated: August 27, 2008   History of Changes

August 21, 2006
August 27, 2008
August 2006
January 2008   (final data collection date for primary outcome measure)
  • Treatment completion in jail [ Time Frame: Until release from jail ] [ Designated as safety issue: No ]
  • Reporting to assigned treatment modality after release [ Time Frame: Within 3 months after release from jail ] [ Designated as safety issue: No ]
  • treatment completion in jail;
  • enrollment in community maintenance after release;
  • attaining therapeutic dose of buprenorphine or methadone in jail;
  • opioid withdrawal symptoms, cravings and agonist effects in jail;
  • length of retention in community maintenance
Complete list of historical versions of study NCT00367302 on ClinicalTrials.gov Archive Site
  • Intention to continue treatment after release [ Time Frame: At release from jail ] [ Designated as safety issue: No ]
  • Re-incarceration [ Time Frame: Within 3 months after release ] [ Designated as safety issue: No ]
  • Frequency of illicit opioid use after release [ Time Frame: Within 3 months after release ] [ Designated as safety issue: No ]
  • Re-arrest [ Time Frame: Within 3 months after release ] [ Designated as safety issue: No ]
  • Severity of re-arrest charges [ Time Frame: Within 3 months after release, if re-arrested ] [ Designated as safety issue: No ]
  • Satisfaction with opioid replacement treatment. [ Time Frame: During jail and 3 months post-release ] [ Designated as safety issue: No ]
  • Opioid withdrawal symptoms and cravings [ Time Frame: During jail and post-release ] [ Designated as safety issue: No ]
  • amount of illicit opioid use after release;
  • attaining therapeutic dose of buprenorphine or methadone in community maintenance;
  • opioid withdrawal symptoms, cravings and agonist effects during community maintenance.
  • criminal recidivism after release;
  • cocaine/crack and other illicit drug use after release;
  • HIV risk behaviors after release;
  • employment after release;
  • psychiatric symptoms after release;
  • satisfaction with opioid replacement treatment.
 
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release

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.

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:

  1. 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.
  2. 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.
  3. 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.

Phase I, Phase II
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Opiate Addiction
  • Drug: buprenorphine
  • Drug: methadone
  • Experimental: Buprenorphine maintenance
  • Active Comparator: Methadone maintenance
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
116
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • opioid dependent patients who meet eligibility requirements for the KEEP program,
  • patients serving sentences who will remain confined for at least 10 days but less than 90 days in the EMTC facility (all male) at Rikers,
  • willingness to accept buprenorphine treatment,
  • expected to reside in New York City after release
  • 18-65 years of age

Exclusion Criteria:

  • receiving methadone treatment in the community at sentencing and remanded to Rikers
  • took non-prescribed 'street methadone' within last 3 days
  • currently receiving more than 20mg/day methadone
  • current psychotic symptoms (e.g., schizophrenia, schizoaffective disorder) requiring referral for mental health intervention, or current treatment with antipsychotic medication)
  • HIV infection with T lymphocytes less than 200 per mm of blood and/or presence of a serious opportunistic infection requiring treatment, or receiving the HIV medication atazanavir.
  • unable to complete English language interview
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00367302
Stephen Magura, Principal Investigator, Western Michigan University
DA020583, 1 R21 DA020583
National Institute on Drug Abuse (NIDA)
  • National Development and Research Institutes, Inc.
  • Western Michigan University
  • New York City Department of Health and Mental Hygiene
Principal Investigator: Stephen Magura, Ph.D. Western Michigan University
National Institute on Drug Abuse (NIDA)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP