Opioid-Related DisordersNCT01874964
Trial of Methadone Maintenance Versus Methadone Detox in Jail
A study testing Methadone Maintenance and Linkage to methadone maintenance in people with Opioid-Related Disorders, run by The Miriam Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Methadone Maintenance and Linkage to methadone maintenance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- able to give informed consent
- age 18 years or older
- willing to remain on MMT and continue MMT after release.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Department of Corrections
Cranston, Rhode Island, 02920
About this study
Official title: A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail
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.
Read the 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.
- Conditions
- Opioid-Related Disorders
- Being tested
- Methadone Maintenance, Linkage to methadone maintenance
- Keywords
- HIV Prevention, Opioid-Related Disorders, Medication Assisted Treatment, Methadone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone MaintenanceBehavioural
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 maintenanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Methadone Maintenance | Experimental | 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. Receives: Behavioral: Methadone Maintenance |
| Methadone Detoxification | Active comparator | 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. Receives: Behavioral: Linkage to methadone maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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,
Measured: 12 months
Secondary outcomes (2)
Treatment retention
length of time engaged in community methadone treatment
Measured: 12 months
Fatal and nonfatal overdose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2013
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874964
- Sponsor's protocol ID
- NIDA-R01DA027211
- Status last verified
- Dec 2010
- First submitted
- 5 Jun 2013
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26028120
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail
- ClinicalTrials.gov ID
- NCT01874964
- Acronym / sponsor ID
- NIDA-R01DA027211
- Conditions
- Opioid-Related Disorders
- Keywords
- HIV Prevention, Opioid-Related Disorders, Medication Assisted Treatment, Methadone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone Maintenance | Experimental | Behavioral: Methadone MaintenanceParticipants 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 comparator | Behavioral: Linkage to methadone maintenanceIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone MaintenanceIndividuals 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. | Behavioural | Methadone Maintenance |
| Linkage to methadone maintenanceIndividuals 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. | Behavioural | Methadone Detoxification |
Primary outcome
Time to post release treatment engagement
Time frame: 30 days post release
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
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
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
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,
2 secondary outcomes
Treatment retention
Time frame: 12 months
Fatal and nonfatal overdose
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
- Derived from this study: PubMed 26028120Rich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methadone Maintenance and Linkage to methadone maintenance in people with Opioid-Related Disorders, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to post release treatment engagement (time frame: 30 days post release). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013.