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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01874964
• Other study ID #: NIDA-R01DA027211
• Status: Active, not recruiting
• Phase: N/A
• First received: June 5, 2013
• Last updated: June 7, 2013
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: December 2010
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: May 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rhode Island Department of Corrections	Cranston	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to post release treatment engagement	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	No
Primary	Reduction of HIV risk behaviors	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	No
Primary	Time to relapse	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	No
Primary	Cost effectiveness	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	No
Secondary	Treatment retention	length of time engaged in community methadone treatment	12 months	No
Secondary	Fatal and nonfatal overdose		12 months	Yes