Trial of Methadone Maintenance Versus Methadone Detox in Jail

Opioid-Related Disorders Clinical Trial

Official title: A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail

Status Active, not recruiting

Clinical Trial Summary

Methadone maintenance treatment (MMT) has been shown to be effective in reducing drug use, criminal activity and recidivism. Given this effectiveness, maintaining individuals who are enrolled in community MMT when committed to the Department of Corrections for short term incarceration would improve post release outcomes. However, this is rarely practiced in the United States. Current practice at the Rhode Island Department of Corrections is to detox inmates on methadone within 30 days of being incarcerated. More than 75% of these individuals are incarcerated for less than six months. The period immediately after release from incarceration is a particularly high-risk time for HIV and other problems including drug relapse and overdose.

The investigators hypothesize that inmates who are incarcerated for 6 months or less will have better outcomes and cost the state less money if they are maintained on their methadone dose and relinked to their community clinic at release, than the current practice of detoxification.

Clinical Trial Description

The purpose of this study is to compare the effectiveness of maintaining methadone treatment during short-term incarceration vs. methadone detoxification on continuing treatment post release, relapse, reducing HIV risk behaviors and reincarceration. Persons who inject opiates are at increased risk for HIV through both injection and sexual practices. A substantial proportion of opiate addicted persons are incarcerated and a majority of the nearly 8 million individuals released from a correctional setting each year have a history of addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV and other problems including drug relapse and overdose. Methadone is the most widely used opiate replacement therapy in the United States. Despite its demonstrated benefit in decreasing drug use, criminal activity, and recidivism, some individuals on methadone treatment are reincarcerated each year. More than 75% of those individuals are incarcerated for less than six months. A program that maintains these individuals at a therapeutic dose increases the likelihood that they will successfully return to treatment upon release.

The following primary specific aims will drive this research:

1. To determine the effect of maintaining methadone treatment during short-term incarceration vs. methadone detoxification on the time-to-post-release methadone treatment re-entry and relapse.

2. To determine whether maintaining methadone treatment during short-term incarceration is more effective in reducing HIV risk behaviors (both injecting and sexual) than methadone detoxification upon community re-entry.

3. To determine whether maintaining methadone treatment during short-term incarceration is more effective in reducing reincarceration than methadone detoxification.

4. To determine the impact on cost of the first three specific aims.

Secondary aims will include determining the effect of methadone maintenance during short-term incarceration versus methadone detoxification on:

• retention in community based methadone treatment;

• the number of fatal and nonfatal overdoses; and

• criminal behavior

The targeted population will be 300 recently incarcerated inmates enrolled in community methadone treatment at the time of incarceration. Follow-up interviews will occur 1-month post release from incarceration and 6, and 12 months from baseline at an independent study site. Both groups will receive a risk behavior reduction counseling intervention and linkage to community methadone treatment upon release. If this project is able to demonstrate that maintaining inmates on methadone for short-term incarcerations is effective, then this can influence correctional policy to work more collaboratively with community substance use treatment providers and to minimize disruption of treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Opioid-Related Disorders

• NCT number: NCT01874964
• Study type: Interventional
• Source: The Miriam Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2010
• Completion date: May 2014