Clinical trial NCT00367302: Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
Official title: Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Opiate Addiction
Keywords: addiction
jail
opiates
buprenorphine
clinical trial
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Western Michigan University
name: New York City Department of Health and Mental Hygiene
First posted: 2006-08-22
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Treatment completion in jail
timeFrame: Until release from jail
measure: Reporting to assigned treatment modality after release
timeFrame: Within 3 months after release from jail
Secondary outcomes:
measure: Intention to continue treatment after release
timeFrame: At release from jail
measure: Re-incarceration
timeFrame: Within 3 months after release
measure: Frequency of illicit opioid use after release
timeFrame: Within 3 months after release
measure: Re-arrest
timeFrame: Within 3 months after release
measure: Severity of re-arrest charges
timeFrame: Within 3 months after release, if re-arrested
measure: Satisfaction with opioid replacement treatment.
timeFrame: During jail and 3 months post-release
measure: Opioid withdrawal symptoms and cravings
timeFrame: During jail and post-release
Other outcomes:
Locations:
Study officials:
affiliation: Western Michigan University
name: Stephen Magura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: