Clinical trial NCT01874964: Trial of Methadone Maintenance Versus Methadone Detox in Jail
Official title: A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: HIV Prevention
Opioid-Related Disorders
Medication Assisted Treatment
Methadone
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 450
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: 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.

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 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.

Primary outcomes:
measure: Time to post release treatment engagement
timeFrame: 30 days post release
measure: Reduction of HIV risk behaviors
timeFrame: 12 months
measure: Time to relapse
timeFrame: 30 days post release
measure: Cost effectiveness
timeFrame: 12 months
Secondary outcomes:
measure: Treatment retention
timeFrame: 12 months
measure: Fatal and nonfatal overdose
timeFrame: 12 months
Other outcomes:
Locations:
city: Cranston
country: United States
facility: Rhode Island Department of Corrections
state: Rhode Island
Study officials:
References:
citation: Rich JD, McKenzie M, Larney S, Wong JB, Tran L, Clarke J, Noska A, Reddy M, Zaller N. Methadone continuation versus forced withdrawal on incarceration in a combined US prison and jail: a randomised, open-label trial. Lancet. 2015 Jul 25;386(9991):350-9. doi: 10.1016/S0140-6736(14)62338-2. Epub 2015 May 28.