Opiate AddictionPhase 1/2NCT00367302
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
A Phase 1/2 study testing buprenorphine and methadone in people with Opiate Addiction, run by National Development and Research Institutes, Inc..
Trial summary
The purpose of the study is to determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- buprenorphine and methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Jan 2008
- Phase
- Phase 1/2
- 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- opioid dependent patients who meet eligibility requirements for the KEEP program,
- patients serving sentences who will remain confined for at least 10 days but less than 90 days in the EMTC facility (all male) at Rikers,
- willingness to accept buprenorphine treatment,
- expected to reside in New York City after release
- 18-65 years of age
Who cannot join
- receiving methadone treatment in the community at sentencing and remanded to Rikers
- took non-prescribed 'street methadone' within last 3 days
- currently receiving more than 20mg/day methadone
- current psychotic symptoms (e.g., schizophrenia, schizoaffective disorder) requiring referral for mental health intervention, or current treatment with antipsychotic medication)
- HIV infection with T lymphocytes less than 200 per mm of blood and/or presence of a serious opportunistic infection requiring treatment, or receiving the HIV medication atazanavir.
- unable to complete English language interview
About this study
The purpose of the study is to determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release.
Read the detailed description
Background: Heroin and other opioid abuse continues as a significant problem among the criminal justice population. In 2002, the criminal justice system was the source of referral for 36% of all substance abuse treatment admissions, the largest source of referrals. Heroin use among offenders has serious health and social consequences. Injection, still the primary route of administration among heroin users, is strongly associated with the transmission of HIV, hepatitis C and other blood-borne diseases. During 1997, 20% to 26% of all people living with HIV in the United States, and 29% to 43% of all those infected with hepatitis C, passed through a correctional facility. The relationship between heroin use and criminal activity has been extensively documented. Although methadone maintenance has been the primary treatment for chronic opioid dependence since the 1970's, correctional systems in the U.S., with very few exceptions (primarily Rikers Island in New York City), have not provided institutional access to methadone maintenance. Regrettably, negative attitudes to methadone are prevalent among criminal justice professionals, the public, treatment providers and opioid-dependent offenders themselves; there is little prospect of that changing soon. Buprenorphine maintenance is a recently approved therapy that may be more acceptable than methadone to the criminal justice system and opioid-dependent offenders. With one minor exception, buprenorphine has never been systematically administered as an opioid replacement therapy in a correctional setting in the U.S.
Aims and Objectives:
- To determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release.
- To conduct a randomized clinical trial of buprenorphine maintenance (N=50) vs. methadone maintenance (N=50) initiated in the jail setting and continuing in the community.
- To determine the reasons that offenders fail to report for community buprenorphine or methadone treatment after release or drop out of community treatment.
Study Design: Consenting eligible inmates at Rikers Island in New York City will be randomly assigned to buprenorphine or methadone maintenance in jail and will be referred to a corresponding community treatment upon their release. Subjects will be followed-up at 3 months after release from jail.
Target Population: Opioid-dependent jail inmates sentenced to 10- 90 days.
- Conditions
- Opiate Addiction
- Being tested
- buprenorphine, methadone
- Keywords
- addiction, jail, opiates, buprenorphine, clinical trial
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buprenorphineDrug
Also called Suboxone
maintenance
methadoneDrug
maintenance
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Buprenorphine maintenance Receives: Drug: buprenorphine |
| 2 | Active comparator | Methadone maintenance Receives: Drug: methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment completion in jail
Measured: Until release from jail
Reporting to assigned treatment modality after release
Measured: Within 3 months after release from jail
Secondary outcomes (7)
Intention to continue treatment after release
Measured: At release from jail
Re-incarceration
Measured: Within 3 months after release
Frequency of illicit opioid use after release
Measured: Within 3 months after release
Re-arrest
Measured: Within 3 months after release
Severity of re-arrest charges
Measured: Within 3 months after release, if re-arrested
Satisfaction with opioid replacement treatment.
Measured: During jail and 3 months post-release
Opioid withdrawal symptoms and cravings
Measured: During jail and post-release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Western Michigan University, New York City Department of Health and Mental Hygiene
- Investigators
- Stephen Magura, Ph.D., Principal investigator, Western Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367302
- Sponsor's protocol ID
- DA020583
- Other IDs
- R21DA020583, 1R21DA020583
- Status last verified
- Apr 2013
- First submitted
- 21 Aug 2006
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
- ClinicalTrials.gov ID
- NCT00367302
- Acronym / sponsor ID
- DA020583
- Conditions
- Opiate Addiction
- Keywords
- addiction, jail, opiates, buprenorphine, clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Western Michigan University, New York City Department of Health and Mental Hygiene
- Study start
- Aug 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Aug 2006 (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.
The purpose of the study is to determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release.
Detailed description
Background: Heroin and other opioid abuse continues as a significant problem among the criminal justice population. In 2002, the criminal justice system was the source of referral for 36% of all substance abuse treatment admissions, the largest source of referrals. Heroin use among offenders has serious health and social consequences. Injection, still the primary route of administration among heroin users, is strongly associated with the transmission of HIV, hepatitis C and other blood-borne diseases. During 1997, 20% to 26% of all people living with HIV in the United States, and 29% to 43% of all those infected with hepatitis C, passed through a correctional facility. The relationship between heroin use and criminal activity has been extensively documented. Although methadone maintenance has been the primary treatment for chronic opioid dependence since the 1970's, correctional systems in the U.S., with very few exceptions (primarily Rikers Island in New York City), have not provided institutional access to methadone maintenance. Regrettably, negative attitudes to methadone are prevalent among criminal justice professionals, the public, treatment providers and opioid-dependent offenders themselves; there is little prospect of that changing soon. Buprenorphine maintenance is a recently approved therapy that may be more acceptable than methadone to the criminal justice system and opioid-dependent offenders. With one minor exception, buprenorphine has never been systematically administered as an opioid replacement therapy in a correctional setting in the U.S.
Aims and Objectives:
- To determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release.
- To conduct a randomized clinical trial of buprenorphine maintenance (N=50) vs. methadone maintenance (N=50) initiated in the jail setting and continuing in the community.
- To determine the reasons that offenders fail to report for community buprenorphine or methadone treatment after release or drop out of community treatment.
Study Design: Consenting eligible inmates at Rikers Island in New York City will be randomly assigned to buprenorphine or methadone maintenance in jail and will be referred to a corresponding community treatment upon their release. Subjects will be followed-up at 3 months after release from jail.
Target Population: Opioid-dependent jail inmates sentenced to 10- 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: buprenorphineBuprenorphine maintenance |
| 2 | Active comparator | Drug: methadoneMethadone maintenance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- opioid dependent patients who meet eligibility requirements for the KEEP program,
- patients serving sentences who will remain confined for at least 10 days but less than 90 days in the EMTC facility (all male) at Rikers,
- willingness to accept buprenorphine treatment,
- expected to reside in New York City after release
- 18-65 years of age
Key exclusion criteria (6 listed)
- receiving methadone treatment in the community at sentencing and remanded to Rikers
- took non-prescribed 'street methadone' within last 3 days
- currently receiving more than 20mg/day methadone
- current psychotic symptoms (e.g., schizophrenia, schizoaffective disorder) requiring referral for mental health intervention, or current treatment with antipsychotic medication)
- HIV infection with T lymphocytes less than 200 per mm of blood and/or presence of a serious opportunistic infection requiring treatment, or receiving the HIV medication atazanavir.
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 |
|---|---|---|
| buprenorphineAlso: Suboxonemaintenance | Drug | 1 |
| methadonemaintenance | Drug | 2 |
Primary outcome
Treatment completion in jail
Time frame: Until release from jail
Reporting to assigned treatment modality after release
Time frame: Within 3 months after release from jail
7 secondary outcomes
Intention to continue treatment after release
Time frame: At release from jail
Re-incarceration
Time frame: Within 3 months after release
Frequency of illicit opioid use after release
Time frame: Within 3 months after release
Re-arrest
Time frame: Within 3 months after release
Severity of re-arrest charges
Time frame: Within 3 months after release, if re-arrested
Satisfaction with opioid replacement treatment.
Time frame: During jail and 3 months post-release
Opioid withdrawal symptoms and cravings
Time frame: During jail and post-release
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
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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.
Stephen Magura, Ph.D. principal investigator
Western Michigan University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing buprenorphine and methadone in people with Opiate Addiction, run by National Development and Research Institutes, Inc..
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment completion in jail (time frame: Until release from jail). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2013.