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.

Study Overview

• Status: Completed
• Conditions: Opiate Addiction
• Intervention / Treatment: Drug: buprenorphine; Drug: methadone

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Buprenorphine maintenance	Drug: buprenorphine; maintenance; Other Names: Suboxone
Active Comparator: 2; Methadone maintenance	Drug: methadone; maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment completion in jail	Until release from jail
Reporting to assigned treatment modality after release	Within 3 months after release from jail

Secondary Outcome Measures

Outcome Measure	Time Frame
Intention to continue treatment after release	At release from jail
Re-incarceration	Within 3 months after release
Frequency of illicit opioid use after release	Within 3 months after release
Re-arrest	Within 3 months after release
Severity of re-arrest charges	Within 3 months after release, if re-arrested
Satisfaction with opioid replacement treatment.	During jail and 3 months post-release
Opioid withdrawal symptoms and cravings	During jail and post-release

Collaborators and Investigators

• Sponsor: National Development and Research Institutes, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); New York City Department of Health and Mental Hygiene; Western Michigan University

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: August 21, 2006
• First Submitted That Met QC Criteria: August 21, 2006
• First Posted (Estimate): August 22, 2006

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 30, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: addiction; buprenorphine; clinical trial; opiates; jail
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Opioid-Related Disorders; Behavior, Addictive; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Buprenorphine; Methadone
• Other Study ID Numbers: DA020583; R21DA020583 (U.S. NIH Grant/Contract); 1R21DA020583 (U.S. NIH Grant/Contract)