Methadone Maintenance for Prisoners (MMP)
Primary Purpose
Heroin Addiction
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Counseling Only
Counseling + Transfer
Counseling + Methadone
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Addiction
Eligibility 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
Sites / Locations
- Metropolitan Transition Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
3
1
2
Arm Description
Outcomes
Primary Outcome Measures
Treatment Retention in the Community
days in community treatment
Heroin Use
opioid urine test results-percent of participants who were opioid-positive
Cocaine Use
cocaine urine test results-percent of participants testing positive for cocaine
HIV-risk Behaviors
Criminal Activity
self reported days of criminal activity
Secondary Outcome Measures
Employment
number of days employed, past 30 days-self report, assessed one year post-prison release
Full Information
NCT ID
NCT00378079
First Posted
September 15, 2006
Last Updated
April 1, 2014
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00378079
Brief Title
Methadone Maintenance for Prisoners
Acronym
MMP
Official Title
Methadone Maintenance for Prisoners
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3
Arm Type
Experimental
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Counseling Only
Intervention Description
Counseling only in prison, with passive referral to drug abuse treatment upon release
Intervention Type
Drug
Intervention Name(s)
Counseling + Transfer
Intervention Description
Counseling only in prison, with opportunity to enter methadone maintenance upon release
Intervention Type
Drug
Intervention Name(s)
Counseling + Methadone
Intervention Description
Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
Primary Outcome Measure Information:
Title
Treatment Retention in the Community
Description
days in community treatment
Time Frame
one year post prison release
Title
Heroin Use
Description
opioid urine test results-percent of participants who were opioid-positive
Time Frame
results at one year post prison release
Title
Cocaine Use
Description
cocaine urine test results-percent of participants testing positive for cocaine
Time Frame
one year post prison release
Title
HIV-risk Behaviors
Time Frame
one year
Title
Criminal Activity
Description
self reported days of criminal activity
Time Frame
one year post prison release
Secondary Outcome Measure Information:
Title
Employment
Description
number of days employed, past 30 days-self report, assessed one year post-prison release
Time Frame
one year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy W Kinlock, Ph.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metropolitan Transition Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Citations:
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.
Results Reference
background
PubMed Identifier
17628351
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. doi: 10.1016/j.drugalcdep.2007.05.022. Epub 2007 Jul 12.
Results Reference
result
PubMed Identifier
18612373
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. doi: 10.1177/0093854807309111.
Results Reference
result
PubMed Identifier
18855822
Citation
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.
Results Reference
result
PubMed Identifier
19339140
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 31.
Results Reference
result
PubMed Identifier
22882399
Citation
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.
Results Reference
result
PubMed Identifier
25580067
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. doi: 10.1080/10509674.2013.782936.
Results Reference
result
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Methadone Maintenance for Prisoners
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