Methadone Maintenance for Prisoners

Heroin Addiction Clinical Trial

— MMP  

Official title:

Methadone Maintenance for Prisoners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378079
• Other study ID #: 1 RO1 DA 16237-03
• Secondary ID: R01DA016237
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2006
• Last updated: April 1, 2014
• Start date: September 2003
• Est. completion date: January 2008

Study information

• Verified date: April 2014
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• 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:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heroin Addiction
• Heroin Dependence

Intervention

Other:
• Counseling Only
Counseling only in prison, with passive referral to drug abuse treatment upon release

Drug:
• Counseling + Transfer
Counseling only in prison, with opportunity to enter methadone maintenance upon release
• Counseling + Methadone
Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release

Locations

Country	Name	City	State
United States	Metropolitan Transition Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. doi: 10.1111/j.1360-0443.2008.002238.x. — View Citation

Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: results at 12 months postrelease. J Subst Abuse Treat. 2009 Oct;37(3):277-85. doi: 10.1016/j.jsat.2009.03.002. Epub 2009 Mar — View Citation

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. — View Citation

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. — View Citation

Kinlock TW, Gordon MS, Schwartz RP, O'Grady KE. Individual Patient and Program Factors Related to Prison and Community Treatment Completion in Prison-Initiated Methadone Maintenance Treatment. J Offender Rehabil. 2013 Oct;52(8):509-528. — View Citation

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.

Wilson ME, Kinlock TW, Gordon MS, O'Grady KE, Schwartz RP. Postprison release HIV-risk behaviors in a randomized trial of methadone treatment for prisoners. Am J Addict. 2012 Sep-Oct;21(5):476-87. doi: 10.1111/j.1521-0391.2012.00250.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Retention in the Community	days in community treatment	one year post prison release	No
Primary	Heroin Use	opioid urine test results-percent of participants who were opioid-positive	results at one year post prison release	No
Primary	Cocaine Use	cocaine urine test results-percent of participants testing positive for cocaine	one year post prison release	No
Primary	HIV-risk Behaviors		one year	No
Primary	Criminal Activity	self reported days of criminal activity	one year post prison release	No
Secondary	Employment	number of days employed, past 30 days-self report, assessed one year post-prison release	one year	No