Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
Condition: Opiate Addiction
MeSH terms: Opioid-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

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.
    

Intervention name(s): buprenorphine; methadone
Intervention type(s): Drug; Drug
Intervention description(s): maintenance; maintenance
Other intervention name(s): Suboxone
Intervention MeSH terms: Buprenorphine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: addiction; jail; opiates; buprenorphine; clinical trial