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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
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Opiate Addiction Drug: buprenorphine Drug: methadone Phase 1 Phase 2

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Buprenorphine maintenance
Drug: buprenorphine
Other Name: Suboxone
Active Comparator: 2
Methadone maintenance
Drug: methadone

Outcome Measures

Primary Outcome Measures :
  1. Treatment completion in jail [ Time Frame: Until release from jail ]
  2. Reporting to assigned treatment modality after release [ Time Frame: Within 3 months after release from jail ]

Secondary Outcome Measures :
  1. Intention to continue treatment after release [ Time Frame: At release from jail ]
  2. Re-incarceration [ Time Frame: Within 3 months after release ]
  3. Frequency of illicit opioid use after release [ Time Frame: Within 3 months after release ]
  4. Re-arrest [ Time Frame: Within 3 months after release ]
  5. Severity of re-arrest charges [ Time Frame: Within 3 months after release, if re-arrested ]
  6. Satisfaction with opioid replacement treatment. [ Time Frame: During jail and 3 months post-release ]
  7. Opioid withdrawal symptoms and cravings [ Time Frame: During jail and post-release ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators
National Development and Research Institutes, Inc.
National Institute on Drug Abuse (NIDA)
Western Michigan University
New York City Department of Health and Mental Hygiene
Principal Investigator: Stephen Magura, Ph.D. Western Michigan University
More Information

Responsible Party: Stephen Magura, Principal Investigator, Western Michigan University
ClinicalTrials.gov Identifier: NCT00367302     History of Changes
Other Study ID Numbers: DA020583
R21DA020583 ( U.S. NIH Grant/Contract )
1R21DA020583 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013

Keywords provided by National Development and Research Institutes, Inc.:
clinical trial

Additional relevant MeSH terms:
Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents