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

Opiate Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367302
• Other study ID #: DA020583
• Secondary ID: R21DA0205831R21D
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 21, 2006
• Last updated: April 30, 2013
• Start date: August 2006
• Est. completion date: January 2008

Study information

• Verified date: April 2013
• Source: National Development and Research Institutes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Addiction

Intervention

Drug:
• buprenorphine
maintenance
• methadone
maintenance

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment completion in jail		Until release from jail	No
Primary	Reporting to assigned treatment modality after release		Within 3 months after release from jail	No
Secondary	Intention to continue treatment after release		At release from jail	No
Secondary	Re-incarceration		Within 3 months after release	No
Secondary	Frequency of illicit opioid use after release		Within 3 months after release	No
Secondary	Re-arrest		Within 3 months after release	No
Secondary	Severity of re-arrest charges		Within 3 months after release, if re-arrested	No
Secondary	Satisfaction with opioid replacement treatment.		During jail and 3 months post-release	No
Secondary	Opioid withdrawal symptoms and cravings		During jail and post-release	No