Trial of Methadone Maintenance Versus Methadone Detox in Jail
A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 5, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 11, 2013
December 1, 2010
3 years
June 5, 2013
June 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Secondary Outcomes (2)
Treatment retention
12 months
Fatal and nonfatal overdose
12 months
Study Arms (2)
Methadone Maintenance
EXPERIMENTALParticipants 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.
Methadone Detoxification
ACTIVE COMPARATORIndividuals 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rhode Island Department of Corrections
Cranston, Rhode Island, 02920, United States
Related Publications (1)
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.
PMID: 26028120DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2013
First Posted
June 11, 2013
Study Start
June 1, 2010
Primary Completion
June 1, 2013
Study Completion
May 1, 2014
Last Updated
June 11, 2013
Record last verified: 2010-12