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 relase from incarceration.

Condition	Intervention
HIV Opioid-Related Disorders	Behavior: Behavior Therapy

Further Study Details: 

Primary Outcomes: Treatment engagement; Time to Treatment engagement from prison release; HIV risk behaviors; measured at Months 1.5, 6, 12, and 24
Secondary Outcomes: 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
Expected Total Enrollment:  326

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00142935

Michelle Mckenzie, M.P.H.      (401)793-4790    mmckenzie@lifespan.org

Rhode Island
      The Miriam Hospital, Providence,  Rhode Island,  02906,  United States

Study chairs or principal investigators

Josiah D Rich, M.P.H., M.D.,  Principal Investigator,  Miriam Hospital   

Study ID Numbers:  NIDA-18641-1; R01-18641-1
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00142935
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06