NCT00378079

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

April 3, 2014

Completed
Last Updated

April 3, 2014

Status Verified

April 1, 2014

Enrollment Period

4.3 years

First QC Date

September 15, 2006

Results QC Date

August 14, 2013

Last Update Submit

April 1, 2014

Conditions

Outcome Measures

Primary Outcomes (5)

  • Treatment Retention in the Community

    days in community treatment

    one year post prison release

  • Heroin Use

    opioid urine test results-percent of participants who were opioid-positive

    results at one year post prison release

  • Cocaine Use

    cocaine urine test results-percent of participants testing positive for cocaine

    one year post prison release

  • HIV-risk Behaviors

    one year

  • Criminal Activity

    self reported days of criminal activity

    one year post prison release

Secondary Outcomes (1)

  • Employment

    one year

Study Arms (3)

3

EXPERIMENTAL
Drug: Counseling + Methadone

1

ACTIVE COMPARATOR
Other: Counseling Only

2

EXPERIMENTAL
Drug: Counseling + Transfer

Interventions

Counseling only in prison, with passive referral to drug abuse treatment upon release

1

Counseling only in prison, with opportunity to enter methadone maintenance upon release

2

Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release

3

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heroin dependence in the year prior to current incarceration
  • 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

You may not qualify if:

  • Pending parole hearing
  • Pending charges
  • Kidney failure
  • Liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metropolitan Transition Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (7)

  • 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.

    BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Heroin Dependence

Interventions

CounselingParturitionMethadone

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaKetonesOrganic Chemicals

Limitations and Caveats

See 2009 manuscript published in the Journal of Substance Abuse Treatment for the a discussion of study limitations. The study was conducted only on males from Baltimore. For results regarding HIV risk behaviors see manuscript by Wilson et. al.

Results Point of Contact

Title
Dr. Timothy Kinlock
Organization
Friends Research Institute

Study Officials

  • Timothy W Kinlock, Ph.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 19, 2006

Study Start

September 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 3, 2014

Results First Posted

April 3, 2014

Record last verified: 2014-04

Locations