CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 87 enrolled
Drug / intervention
Pre-release Initiation of MMT +2 morebehavioral
Likely dose
Methadone starting at 5 mg with 2 mg daily increase until release (Arm 1); post-release initiation within 24-48 hours (Arm 2)AI-extracted
Key inclusion· 8
  • Currently incarcerated at Rhode Island Department of Corrections with scheduled release ≥28 days after enrollment
  • Heroin dependent with recent injection history OR prior enrollment in methadone treatment for heroin addiction with history of injection drug use
  • Desire to enter methadone treatment upon release and plans to secure funding after study completion
  • History of prior tolerance to methadone
Key exclusion· 4
  • Currently receiving methadone at Rhode Island Department of Corrections
  • Currently undergoing non-narcotic detoxification from illicit opiates at Rhode Island Department of Corrections
  • Plans to leave Rhode Island within two years following enrollment
  • Incarceration length exceeding two years at time of enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00142935
NCT00142935N/ACompleted

Opiate Replacement Therapy at Release From Incarceration

The Miriam Hospital·interventional·Posted Sep 2, 2005·Updated Jun 6, 2014

In Brief

A clinical study evaluating Pre-release Initiation of MMT, Post Release Initiation of MMT., and 1 other intervention for HIV Prevention and Opioid-Related Disorders. Completed, enrolled 87 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2, 2005
Enrollment StartSep 1, 2006
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

Pre-release Initiation of MMTbehavioral

Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.

Post Release Initiation of MMT.behavioral

Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.

Standard of Care Plusbehavioral

Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.