Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release

This study has been completed.
Sponsor:
Collaborators:
Western Michigan University
New York City Department of Health and Mental Hygiene
Information provided by:
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT00367302
First received: August 21, 2006
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
Experimental: 1
Buprenorphine maintenance
Drug: buprenorphine
maintenance
Other Name: Suboxone
Active Comparator: 2
Methadone maintenance
Drug: methadone
maintenance

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367302

Sponsors and Collaborators
National Development and Research Institutes, Inc.
Western Michigan University
New York City Department of Health and Mental Hygiene
Investigators
Principal Investigator: Stephen Magura, Ph.D. Western Michigan University
  More Information

No publications provided

Responsible Party: Stephen Magura, Principal Investigator, Western Michigan University
ClinicalTrials.gov Identifier: NCT00367302     History of Changes
Other Study ID Numbers: DA020583, R21DA020583, 1 R21 DA020583
Study First Received: August 21, 2006
Last Updated: April 30, 2013
Health Authority: United States: Federal Government

Keywords provided by National Development and Research Institutes, Inc.:
addiction
jail
opiates
buprenorphine
clinical trial

Additional relevant MeSH terms:
Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 22, 2014