Trial of Methadone Maintenance Versus Methadone Detox in Jail
Information source: The Miriam Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders
Intervention: Methadone Maintenance (Behavioral); Linkage to methadone maintenance (Behavioral)
Phase: N/A
Status: Active, not recruiting
Sponsored by: The Miriam Hospital
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 Details
Official title: A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Time to post release treatment engagementReduction of HIV risk behaviors Time to relapse Cost effectiveness
Secondary outcome: Treatment retentionFatal and nonfatal overdose
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Rhode Island Department of Corrections, Cranston, Rhode Island 02920, United States
Additional Information
Starting date: June 2010
Last updated: June 7, 2013
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