Clinical trial NCT00142935: Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1
Official title: Opiate Replacement Therapy at Release From Incarceration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Opioid-Related Disorders
Keywords: HIV Prevention
Opioid-Related Disorders
Medication Assisted Treatment
Methadone
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 was 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 evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.

Detailed description: 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 was 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 evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.

Participants in this were randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 initiated methadone opiate replacement therapy about 1 month prior to release from incarceration. They proceeded with a methadone program of their choice upon release and received short-term payment to cover treatment costs. Participants enrolled in Group 2 were referred to a methadone program of their choice and received short-term payment to cover treatment costs. Participants enrolled in Group 3 were referred to a program of choice upon release from incarceration without receiving financial assistance. All participants had 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 occurred at Months 1.5, 6, and 12. These included interviews and urine specimens for toxicology analysis to verify self-reports.

Eligibility 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

Primary outcomes:
measure: Treatment Engagement
timeFrame: within 30 days post release of incarceration
measure: Time to MMT Initiation Post Release Based on Clinic Chart Review
timeFrame: within 30 days post release from incarceration
measure: HIV Risk Behaviors - Self Report
timeFrame: 6 month follow-up interviews
Secondary outcomes:
measure: Drug Use
timeFrame: 6 month follow-up interviews
measure: Fatal Overdose
timeFrame: Within six months from release of incarceration
measure: Non-fatal Overdose
timeFrame: 6 month follow-up interviews
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Josiah D Rich, M.P.H., M.D.
role: PRINCIPAL_INVESTIGATOR
References: