Methadone Maintenance for Prisoners - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00378079

Purpose

This five-year study examines the benefits of methadone maintenance treatment initiated in prison and continued in the community to male offenders who were previously, but not currently, heroin-dependent. It is anticipated that such prisoners will have more favorable outcomes in the year following release with regard to drug abuse, crime, and HIV risk behavior than either prisoners who receive counseling only or begin initiation of methadone maintenance in the community

Condition	Intervention	Phase
Heroin Addiction	Other: Counseling Only Drug: Counseling + Transfer Drug: Counseling + Methadone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Methadone Maintenance for Prisoners

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Heroin

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

treatment entry and retention in the community [ Time Frame: one year ] [ Designated as safety issue: No ]
heroin use [ Time Frame: one year ] [ Designated as safety issue: No ]
cocaine use [ Time Frame: one year ] [ Designated as safety issue: No ]
HIV-risk behaviors [ Time Frame: one year ] [ Designated as safety issue: No ]
criminal activity [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

employment [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	211
Study Start Date:	September 2003
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 3	Drug: Counseling + Methadone Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
Active Comparator: 1	Other: Counseling Only Counseling only in prison, with passive referral to drug abuse treatment upon release
Experimental: 2	Drug: Counseling + Transfer Counseling only in prison, with opportunity to enter methadone maintenance upon release

Detailed Description:

Most prisoners with histories of pre-incarceration heroin addiction do not receive treatment while incarcerated or upon release. Effective treatment for such prisoners is urgently needed because rapid relapse typically follows release. Relapse is associated with increased risk for HIV, overdose death, criminal activity, and reincarceration. Other than three studies of methadone maintenance with short-term jail inmates, the only study of longer-term inmates who were previously, but not currently, heroin-dependent was the investigator's pilot study with pre-release inmates. Based on that pilot study, which found that initiating maintenance treatment is feasible and facilitates post-release treatment entry, the present study provides a more rigorous examination of this unique treatment approach.

Eligibility

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

Criteria

Inclusion Criteria:

Heroin dependence in the year prior to current incarceration
3-6 months left to serve in prison-male pre-release inmate suitability for methadone maintenance as determined by medical evaluation
Willingness to enroll in methadone maintenance
Having a Baltimore address

Exclusion Criteria:

Pending parole hearing
Pending charges
Kidney failure
Liver failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378079

Locations

United States, Maryland
Metropolitan Transition Center
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Timothy W Kinlock, Ph.D.

Friends Research Institute, Inc.

More Information

Publications:

Kinlock TW, Gordon MS, Schwartz RP, O'Grady K, Fitzgerald TT, Wilson M. A randomized clinical trial of methadone maintenance for prisoners: results at 1-month post-release. Drug Alcohol Depend. 2007 Dec 1;91(2-3):220-7. Epub 2007 Jul 12.

Kinlock TW, Gordon MS, Schwartz RP, O'Grady KE. A Study of Methadone Maintenance For Male Prisoners: 3-Month Postrelease Outcomes. Crim Justice Behav. 2008;35(1):34-47.

Gordon MS, Kinlock TW, Schwartz RP, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-reelase. Addiction 103:1333-1342,2008

Kinlock TW, Schwartz RP, Gordon MS. The significance of interagency collaboration in developing opioid agonist programs for inmates. Corrections Compendium 30(3)6-9,28-30,2005.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gordon MS, Kinlock TW, Schwartz RP, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release. Addiction. 2008 Aug;103(8):1333-42.

Responsible Party:	Timothy W. Kinlock, Ph.D., Principal Investigator, Friends Research Institute
ClinicalTrials.gov Identifier:	NCT00378079 History of Changes
Other Study ID Numbers:	1 RO1 DA 16237-03
Study First Received:	September 15, 2006
Last Updated:	August 8, 2008
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Heroin Dependence
Behavior, Addictive
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
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
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012