Trial of Methadone Maintenance Versus Methadone Detox in Jail

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by The Miriam Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01874964
First received: June 5, 2013
Last updated: June 7, 2013
Last verified: December 2010
  Purpose

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.


Condition Intervention
Opioid-Related Disorders
Behavioral: Methadone Maintenance
Behavioral: Linkage to methadone maintenance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Time to post release treatment engagement [ Time Frame: 30 days post release ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days post release ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    length of time engaged in community methadone treatment

  • Fatal and nonfatal overdose [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: June 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methadone Maintenance
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.
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.
Active Comparator: Methadone Detoxification
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.
Behavioral: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874964

Locations
United States, Rhode Island
Rhode Island Department of Corrections
Cranston, Rhode Island, United States, 02920
Sponsors and Collaborators
The Miriam Hospital
  More Information

No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01874964     History of Changes
Other Study ID Numbers: NIDA-R01DA027211
Study First Received: June 5, 2013
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

Keywords provided by The Miriam Hospital:
HIV Prevention
Opioid-Related Disorders
Medication Assisted Treatment
Methadone

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 27, 2014