Opioid DependencePhase 2/3NCT01082679
Treatment for Opioid Dependent Offenders
A Phase 2/3 study testing Methadone and buprenorphine (Suboxone) in people with Opioid Dependence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Methadone and buprenorphine (Suboxone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2011
- Phase
- Phase 2/3
- 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
- diagnosis of opioid dependence
- opioid positive urine drug screen
- participation in local Drug Treatment Court or Treatment Alternative Program
- women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study
Who cannot join
- current alcohol or sedative dependence
- pregnancy
- women who are currently breast-feeding
- complex psychiatric co-morbidity (e.g. suicidality, psychosis)
- complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
- current pharmacotherapy with an agent which is contraindicated in combination with Suboxone or methadone according to drug labeling
- paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53715
About this study
This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. The questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants.
- Conditions
- Opioid Dependence
- Being tested
- Methadone, buprenorphine (Suboxone)
- Keywords
- opioid dependent, methadone, Suboxone, buprenorphine
- 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.
MethadoneDrug
daily for 12 months
buprenorphine (Suboxone)Drug
daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| methadone via specialty care | Other | Not described Receives: Drug: Methadone |
| Suboxone via specialty care | Other | Not described Receives: Drug: buprenorphine (Suboxone) |
| Suboxone via primary care | Other | Not described Receives: Drug: buprenorphine (Suboxone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of participants in the study
This study is focused on Dane County Drug Treatment Court and Treatment Alternative Program participants.
The study will determine feasibility of monitoring participants in primary care as opposed to the usual standard of specialty care.
Feasibility of monitoring participants will be studied in terms of retention rate of participants in the study
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 posted8 Mar 2010 (estimated)
- Study startJun 2009
- Primary completionMar 2011
- Study completionMay 2011
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 DependenceStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Responsible party
- Sponsor
- Investigators
- Randy Brown, MD, PhD, Principal investigator, University of Wisconsin - Madison, Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082679
- Sponsor's protocol ID
- H-2008-0242
- Status last verified
- May 2019
- First submitted
- 5 Mar 2010
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brown R, Gassman M, Hetzel S, Berger L. Community-based treatment for opioid dependent offenders: a pilot study. Am J Addict. 2013 Sep-Oct;22(5):500-2. doi: 10.1111/j.1521-0391.2013.12049.x. Epub 2013 Apr 3.
PubMed 23952897
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Opioid Dependent Offenders
- ClinicalTrials.gov ID
- NCT01082679
- Acronym / sponsor ID
- H-2008-0242
- Conditions
- Opioid Dependence
- Keywords
- opioid dependent, methadone, Suboxone, buprenorphine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Mar 2010 (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.
This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. The questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| methadone via specialty care | Other | Drug: Methadone |
| Suboxone via specialty care | Other | Drug: buprenorphine (Suboxone) |
| Suboxone via primary care | Other | Drug: buprenorphine (Suboxone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of opioid dependence
- opioid positive urine drug screen
- participation in local Drug Treatment Court or Treatment Alternative Program
- women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study
Key exclusion criteria (7 listed)
- current alcohol or sedative dependence
- pregnancy
- women who are currently breast-feeding
- complex psychiatric co-morbidity (e.g. suicidality, psychosis)
- complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
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 |
|---|---|---|
| Methadonedaily for 12 months | Drug | methadone via specialty care |
| buprenorphine (Suboxone)daily for 12 months | Drug | Suboxone via primary care, Suboxone via specialty care |
Primary outcome
Retention rate of participants in the study
Time frame: 12 months
This study is focused on Dane County Drug Treatment Court and Treatment Alternative Program participants. The study will determine feasibility of monitoring participants in primary care as opposed to the usual standard of specialty care. Feasibility of monitoring participants will be studied in terms of retention rate of participants in the study
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 5 Jun 2023.
- Results publication: PubMed 23952897Brown R, Gassman M, Hetzel S, Berger L. Community-based treatment for opioid dependent offenders: a pilot study. Am J Addict. 2013 Sep-Oct;22(5):500-2. doi: 10.1111/j.1521-0391.2013.12049.x. Epub 2013 Apr 3.
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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.
Randy Brown, MD, PhD principal investigator
University of Wisconsin - Madison, Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methadone and buprenorphine (Suboxone) in people with Opioid Dependence, run by University of Wisconsin, Madison 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 4 inclusion and 7 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 5 Jun 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Retention rate of participants in the study (time frame: 12 months). 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 NCT01082679, 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 5 Jun 2023.