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Trial of Methadone Maintenance Versus Methadone Detox in Jail

Primary Purpose

Opioid-Related Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methadone Maintenance
Linkage to methadone maintenance
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid-Related Disorders focused on measuring HIV Prevention, Opioid-Related Disorders, Medication Assisted Treatment, Methadone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rhode Island Department of Corrections

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methadone Maintenance

Methadone Detoxification

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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,

Secondary Outcome Measures

Treatment retention
length of time engaged in community methadone treatment
Fatal and nonfatal overdose

Full Information

First Posted
June 5, 2013
Last Updated
June 7, 2013
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01874964
Brief Title
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

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
HIV Prevention, Opioid-Related Disorders, Medication Assisted Treatment, Methadone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methadone Maintenance
Arm Type
Experimental
Arm Description
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.
Arm Title
Methadone Detoxification
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Methadone Maintenance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Linkage to methadone maintenance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to post release treatment engagement
Description
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.
Time Frame
30 days post release
Title
Reduction of HIV risk behaviors
Description
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.
Time Frame
12 months
Title
Time to relapse
Description
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.
Time Frame
30 days post release
Title
Cost effectiveness
Description
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,
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Treatment retention
Description
length of time engaged in community methadone treatment
Time Frame
12 months
Title
Fatal and nonfatal overdose
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rhode Island Department of Corrections
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26028120
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.
Results Reference
derived

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Trial of Methadone Maintenance Versus Methadone Detox in Jail

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