Trial of Methadone Maintenance Versus Methadone Detox in Jail

June 7, 2013 updated by: The Miriam Hospital

A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Rhode Island Department of Corrections

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • currently incarcerated at the RI Department of Corrections
  • enrolled in a Rhode Island methadone treatment program at the time of incarceration
  • currently maintained at the pre-incarceration methadone dosage level
  • estimated total incarceration time of < 6 months and > 1 week
  • willing to be randomized and to conduct follow-up interviews for 12 months
  • English or Spanish-speaking
  • able to give informed consent
  • age 18 years or older
  • willing to remain on MMT and continue MMT after release.

Exclusion Criteria:

  • pregnancy (pregnant women are maintained on pre-incarceration levels of methadone throughout their pregnancy for their health and the health of the fetus by the RI DOC, so are NOT eligible to be randomized to Arm 2)
  • not fulfilling all of the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methadone Maintenance
Participants assigned to Arm 1 will be maintained on ther pre-incarceration methadone dosage during short term incarceration (6 months or less) and will be actively transferred back to their community methadone clinic upon release from incarceration. Additionally, the study will pay for the cost of methadone maintenance treatment for 10 weeks after re-enrollment post release.
Behavioral: Methadone Maintenance
Individuals who are enrolled in methadone maintenance treatment at the time of incarceration are maintained on pre-incarceration dosage levels of methadone during short-term (6 months or less)incarceration. They will be actively assisted to return to their home clinic upon release and receive 10 financial assistance with treatment payments.
Active Comparator: Methadone Detoxification
Individuals assigned to Arm 2 will undergo methadone detoxification as is standard procedure at the Rhode Island Department of Corrections. They will receive active assistance with returning to their home methadone clinic upon release from incarceration and 10 weeks financial assistance to pay for treatment.
Behavioral: Linkage to methadone maintenance
Individuals in the comparison arm will undergo methadone detoxification during short term incarceration, however, they will be actively assisted to return to their home clinic upon release and receive 10 financial assistance with treatment payments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to post release treatment engagement
Time Frame: 30 days post release
Do individuals maintained on MMT during short term incarceration return to their community methadone clinic more rapidly than those who undergo methadone detoxification during short term incarceration? Individuals must return within 30 days of post release to be or be counted as not returning.
30 days post release
Reduction of HIV risk behaviors
Time Frame: 12 months
To determine whether individuals maintained on MMT during short term incarceration report fewer HIV risk behaviors (both drug use and sexual) as compared to standard of care arm.
12 months
Time to relapse
Time Frame: 30 days post release
To determine whether individuals maintained on MMT during short term incarceration report longer to relapse (or no relapse) to opiate use as compared to standard of care arm.
30 days post release
Cost effectiveness
Time Frame: 12 months
To determine the costs, cost-effectiveness and cost-benefit associated with continuing methadone maintenance versus detoxification for jailed individuals. Variables to be assessed are: reincarceration, health care utilization (i.e. emergency room use, medications), subsidized housing,
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment retention
Time Frame: 12 months
length of time engaged in community methadone treatment
12 months
Fatal and nonfatal overdose
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 7, 2013

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-R01DA027211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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