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| Sponsored by: |
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 |
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Heroin Addiction |
Other: Counseling Only Drug: Counseling + Transfer Drug: Counseling + Methadone |
Phase III |
| MedlinePlus related topics: | Heroin |
| ChemIDplus related topics: | Methadone Methadone hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | Methadone Maintenance for Prisoners |
| 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 |
| 3: Experimental |
Drug: Counseling + Methadone
Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
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| 1: Active Comparator |
Other: Counseling Only
Counseling only in prison, with passive referral to drug abuse treatment upon release
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| 2: Experimental |
Drug: Counseling + Transfer
Counseling only in prison, with opportunity to enter methadone maintenance upon release
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |||||
| Metropolitan Transition Center | |||||
| Baltimore, Maryland, United States, 21201 | |||||
| Principal Investigator: | Timothy W Kinlock, Ph.D. | Friends Research Institute, Inc. |
More Information
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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.
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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
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| Responsible Party: | Friends Research Institute ( Timothy W. Kinlock, Ph.D., Principal Investigator ) |
| Study ID Numbers: | 1 RO1 DA 16237-03 |
| First Received: | September 15, 2006 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00378079 |
| Health Authority: | United States: Federal Government |
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