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Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1
This study is ongoing, but not recruiting participants.
Study NCT00142935   Information provided by National Institute on Drug Abuse (NIDA)
First Received: September 1, 2005   Last Updated: May 4, 2009   History of Changes

September 1, 2005
May 4, 2009
October 2005
March 2010   (final data collection date for primary outcome measure)
  • Treatment engagement [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]
  • Time to Treatment engagement from prison release [ Time Frame: 1.5, 6 month follow-up interivews ] [ Designated as safety issue: No ]
  • HIV risk behaviors [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]
  • Treatment engagement
  • Time to Treatment engagement from prison release
  • HIV risk behaviors; measured at Months 1.5, 6, 12, and 24
Complete list of historical versions of study NCT00142935 on ClinicalTrials.gov Archive Site
  • Drug use [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]
  • Fatal overdose [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: Yes ]
  • Non-fatal overdose [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: Yes ]
  • Drug use; measured at Months 1.5, 6, 12, and 24
  • Fatal overdose; measured at Months 1.5, 6, 12, and 24
  • Non-fatal overdose; measured at Months 1.5, 6, 12, and 24
 
Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1
Opiate Replacement Therapy at Release From Incarceration

Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to opiates. Many of these individuals pass through a correctional setting each year, creating an opportunity for linkage to substance abuse treatment. The purpose of this study is to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study will evaluate the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.

A substantial proportion of individuals addicted to heroin are incarcerated while addicted and a majority of individuals released from a correctional setting have a history of heroin addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV transmission and other problems, including drug relapse and overdose. Methadone treatment is the most widely used opiate replacement therapy in the United States and has been shown to decrease HIV risk, as well as drug use, addiction relapse, and criminal activity. The purpose of this study is to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study will evaluate the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.

Participants in this 3-year study will be randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. Participants enrolled in Group 3 will be referred to a program of choice upon release from incarceration without receiving financial assistance. All participants will have the opportunity to partake in existing support programs available at the Rhode Island Department of Corrections while incarcerated and in the community upon release. Follow-up assessments will occur at Months 1.5, 6, 12 and 24. These will include interviews and urine specimens for toxicology analysis to verify self-reports.

 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • HIV Prevention
  • Opioid-Related Disorders
  • Behavioral: Pre-release Initiation of MMT
  • Behavioral: Post Release Initiation of MMT.
  • Behavioral: Standard of Care Plus
  • Experimental: Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
  • Experimental: Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
  • Active Comparator: Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently incarcerated at the Rhode Island Department of Corrections with a scheduled release date at least 28 days after enrollment
  • Incarceration length not to have exceeded two years at the time of enrollment
  • Heroin dependent with self-reported heroin injection in the month prior to incarceration OR enrollment in a methadone treatment program prior to incarceration for heroin addiction with a history of injection drug use
  • Desire to enter methadone treatment upon release and plans to secure funding for methadone treatment after study completion
  • History of prior tolerance to methadone
  • History of at least one drug-related incarceration
  • Speaks English or Spanish
  • Plans to remain in Rhode Island for the duration of the study (24 months)
  • Ability to provide at least two names of individuals who can verify participant information

Exclusion Criteria:

  • Currently receiving methadone at the Rhode Island Department of Corrections
  • Currently undergoing a non-narcotic detoxification from illicit opiates at the Rhode Island Department of Corrections
  • Plans to leave Rhode Island within the two years following enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00142935
Josiah D. Rich, MD, MPH, Principal Investigator, The Miriam Hospital/Warren Alpert Medical School of Brown University
NIDA-18641-1, R01-DA018641-1, DPMC
National Institute on Drug Abuse (NIDA)
The Miriam Hospital
Principal Investigator: Josiah D Rich, M.P.H., M.D. The Miriam Hospital
National Institute on Drug Abuse (NIDA)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP