Opioid DependencePhase 3NCT01843751
Dane County Drug Court Study for Addicted Offenders
A Phase 3 study testing buprenorphine/naloxone in people with Opioid Dependence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The proposed work addresses critical health and public safety issues in the U.S. and in Wisconsin: the intersection of addiction and crime and the prevention of associated individual and public health complications. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- buprenorphine/naloxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enrollment in the Drug Treatment Court
- diagnosis of opioid dependence using the Addiction Severity Index-Lite and diagnosis by clinical staff of referring units
- opioid positive urine drug screen at baseline
- women of childbearing potential who have a negative screening urine pregnancy test and are willing to use reliable birth control methods throughout the duration of the study.
Who cannot join
- pregnancy
- women who are currently breastfeeding
- complex psychiatric co-morbidity (e.g. suicidality, psychosis)
- complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
- or current pharmacotherapy with an agent which is contraindicated in combination with buprenorphine/naloxone according to drug labeling (
- Specific medical conditions, to be identified via initial medical history and examination, which would necessitate exclusion from study participation include: 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, Department of Family Medicine
Madison, Wisconsin, 53715
About this study
Official title: Health Promotion and Public Safety: Community-based Collaborative Services to Addicted Offenders
The proposed work addresses critical health and public safety issues in the U.S. and in Wisconsin: the intersection of addiction and crime and the prevention of associated individual and public health complications. The results will provide justification for the expanded involvement of primary care in the treatment of substance-related disorders (opioid dependence in particular) and the prevention of their complications. As such, the project answers to federal calls for the expansion of substance abuse treatment into primary care settings and to objectives within the Alcohol and Drug Focus Area of Healthiest Wisconsin 2020.
Read the detailed description
Addiction adversely affects individual and family well-being, public health, and public safety across the state of WI. Appropriate treatment can prevent myriad physical consequences of addiction, such as HIV, viral hepatitis, endocarditis, motor vehicle accidents and other trauma. Treatment to one addicted individual prevents 63 crimes per year-not including intimate partner and child abuse, which remain under-reported. An individual's contact with the WI criminal justice system constitutes a critical point for referral into supervised treatment to promote the recovery of the user and, hence, public health and safety. This project and related future work will help optimize prevention, intervention, and policy development targeting substance use, crime and related consequences. Specifically, the proposed work will 1) examine the impact of collaborative community treatment models involving generalist physician offices, specialist treatment facilities, and criminal justice, 2) examine HIV risk behaviors and their response to study conditions, and 3) disseminate results to state and national audiences to promote collaboration between criminal justice, specialist care, and generalist health care in reducing drug-related harms to individual and population health. There is a high prevalence of opiate dependence among the criminally involved. Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
The proposed project seeks to test models to expand treatment access for substance dependent individuals. The project builds logically upon previous work by the PI. Substance dependent offenders are specifically chosen for investigation due to (1) the greater severity and prevalence of substance use problems and complications when compared to the more general adult substance-dependent population, (2) the impact of drug-related criminal behavior upon victims and upon the safety and well-being of our communities, and (3) the suitability of our team and community-based collaborators to conduct research with addicted offenders in order to promote individual recovery, public health, and public safety.
To contribute to knowledge regarding potential models for the expansion of treatment and supervision for substance dependent offenders, the current project and related future work will aim to:
- Compare models of treatment involving (1) specialist-directed treatment followed by physician-office based treatment, and (2) physician-office-based treatment alone.
- Determine if and to what degree a period of stabilization with specialist-directed treatment improves outcomes over physician-office-based treatment alone.
- Clarify the optimal period of time for such a period of "specialist stabilization."
In this study, "stabilization" refers to a period of time at the front end of treatment during which the addicted offender participates in a more stringent set of supervisory conditions tied to their medication dispensing. This includes daily reporting for medication dosing and more frequent urine drug testing.
The primary study outcome will be time to commission of new crime. The primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete.
Secondary outcomes include ongoing drug use as measured by urine drug testing, previously validated self-report measures; and treatment uptake and adherence. Secondary outcomes also include standardized measures of HIV risk behaviors, health services utilization, and cost benefit (societal perspective).
All subjects will be recruited via Journey Mental Health Center (formerly Mental Health Center of Dane County), which serves as the assessment unit for the Dane County Drug Treatment Court (DTC). This study will determine whether varying periods of initial stabilization in specialist treatment affects outcomes vs. physician-office treatment alone. The study will randomize 40 participants to one of 2 conditions characterized by the duration or lack of the "specialist stabilization period": 1) buprenorphine/naloxone via physician office (B-PO) x 10 months, or 2) buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. Subjects will receive behavioral treatment and court supervision as usual. The primary outcome will be time to re-arrest/new crime. Secondary outcomes include ongoing drug use measured by 1) urine drug testing, and 2) validated self-report measures, treatment uptake and adherence, standardized measures of HIV risk behaviors, health services utilization, and cost benefit.
- Conditions
- Opioid Dependence
- Being tested
- buprenorphine/naloxone
- 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.
buprenorphine/naloxoneDrug
Also called Suboxone
Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
| Study group | Role | What they receive |
|---|---|---|
| Physician Office | Active comparator | Buprenorphine/naloxone via physician office (B-PO) x 10 months Receives: Drug: buprenorphine/naloxone |
| Specialist Center | Experimental | Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic. Receives: Drug: buprenorphine/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With New Crime
The primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete.
Measured: 2 years
Secondary outcomes (4)
Number of Days From Treatment Initiation to First Drug Use
Number of days from treatment initiation to first drug use thereafter
Measured: 6 months
Initiation of Medication Assisted Treatment
Initiation of medication assisted treatment (yes/no)
Measured: 6 months
Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score
The RAB is a self-administered, multiple choice questionnaire. It offers a quick and confidential assessment of both needle sharing practices and sexual activity associated with HIV transmission.
The RAB is composed of 45 simple questions which uses discrete response. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The RAB is scored by adding the values that correspond to the responses selected by the subject for the items. This total score is then divided by 40, the highest possible score for the overall instrument, yielding a score from 0 to 1.
HIV risk behaviors will be assessed via score on the Risk Assessment Battery at baseline and month 6--difference between baseline and month 6.
Measured: baseline and 6 months
Number of Emergency Room Visits
Number of emergency room visits over 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall T Brown, MD, PhD, Principal investigator, University of Wisconsin, Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843751
- Sponsor's protocol ID
- 2012-0226
- Status last verified
- Mar 2019
- First submitted
- 17 Apr 2013
- Last updated
- 7 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion and Public Safety: Community-based Collaborative Services to Addicted Offenders
- ClinicalTrials.gov ID
- NCT01843751
- Acronym / sponsor ID
- 2012-0226
- Conditions
- Opioid Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed work addresses critical health and public safety issues in the U.S. and in Wisconsin: the intersection of addiction and crime and the prevention of associated individual and public health complications. The results will provide justification for the expanded involvement of primary care in the treatment of substance-related disorders (opioid dependence in particular) and the prevention of their complications. As such, the project answers to federal calls for the expansion of substance abuse treatment into primary care settings and to objectives within the Alcohol and Drug Focus Area of Healthiest Wisconsin 2020.
Detailed description
Addiction adversely affects individual and family well-being, public health, and public safety across the state of WI. Appropriate treatment can prevent myriad physical consequences of addiction, such as HIV, viral hepatitis, endocarditis, motor vehicle accidents and other trauma. Treatment to one addicted individual prevents 63 crimes per year-not including intimate partner and child abuse, which remain under-reported. An individual's contact with the WI criminal justice system constitutes a critical point for referral into supervised treatment to promote the recovery of the user and, hence, public health and safety. This project and related future work will help optimize prevention, intervention, and policy development targeting substance use, crime and related consequences. Specifically, the proposed work will 1) examine the impact of collaborative community treatment models involving generalist physician offices, specialist treatment facilities, and criminal justice, 2) examine HIV risk behaviors and their response to study conditions, and 3) disseminate results to state and national audiences to promote collaboration between criminal justice, specialist care, and generalist health care in reducing drug-related harms to individual and population health. There is a high prevalence of opiate dependence among the criminally involved. Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
The proposed project seeks to test models to expand treatment access for substance dependent individuals. The project builds logically upon previous work by the PI. Substance dependent offenders are specifically chosen for investigation due to (1) the greater severity and prevalence of substance use problems and complications when compared to the more general adult substance-dependent population, (2) the impact of drug-related criminal behavior upon victims and upon the safety and well-being of our communities, and (3) the suitability of our team and community-based collaborators to conduct research with addicted offenders in order to promote individual recovery, public health, and public safety.
To contribute to knowledge regarding potential models for the expansion of treatment and supervision for substance dependent offenders, the current project and related future work will aim to:
- Compare models of treatment involving (1) specialist-directed treatment followed by physician-office based treatment, and (2) physician-office-based treatment alone.
- Determine if and to what degree a period of stabilization with specialist-directed treatment improves outcomes over physician-office-based treatment alone.
- Clarify the optimal period of time for such a period of "specialist stabilization."
In this study, "stabilization" refers to a period of time at the front end of treatment during which the addicted offender participates in a more stringent set of supervisory conditions tied to their medication dispensing. This includes daily reporting for medication dosing and more frequent urine drug testing.
The primary study outcome will be time to commission of new crime. The primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete.
Secondary outcomes include ongoing drug use as measured by urine drug testing, previously validated self-report measures; and treatment uptake and adherence. Secondary outcomes also include standardized measures of HIV risk behaviors, health services utilization, and cost benefit (societal perspective).
All subjects will be recruited via Journey Mental Health Center (formerly Mental Health Center of Dane County), which serves as the assessment unit for the Dane County Drug Treatment Court (DTC). This study will determine whether varying periods of initial stabilization in specialist treatment affects outcomes vs. physician-office treatment alone. The study will randomize 40 participants to one of 2 conditions characterized by the duration or lack of the "specialist stabilization period": 1) buprenorphine/naloxone via physician office (B-PO) x 10 months, or 2) buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. Subjects will receive behavioral treatment and court supervision as usual. The primary outcome will be time to re-arrest/new crime. Secondary outcomes include ongoing drug use measured by 1) urine drug testing, and 2) validated self-report measures, treatment uptake and adherence, standardized measures of HIV risk behaviors, health services utilization, and cost benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician Office | Active comparator | Drug: buprenorphine/naloxoneBuprenorphine/naloxone via physician office (B-PO) x 10 months |
| Specialist Center | Experimental | Drug: buprenorphine/naloxoneBuprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Enrollment in the Drug Treatment Court
- diagnosis of opioid dependence using the Addiction Severity Index-Lite and diagnosis by clinical staff of referring units
- opioid positive urine drug screen at baseline
- women of childbearing potential who have a negative screening urine pregnancy test and are willing to use reliable birth control methods throughout the duration of the study.
Key exclusion criteria (6 listed)
- pregnancy
- women who are currently breastfeeding
- complex psychiatric co-morbidity (e.g. suicidality, psychosis)
- complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
- or current pharmacotherapy with an agent which is contraindicated in combination with buprenorphine/naloxone according to drug labeling (
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 |
|---|---|---|
| buprenorphine/naloxoneAlso: SuboxoneBuprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system. | Drug | Physician Office, Specialist Center |
Primary outcome
Number of Participants With New Crime
Time frame: 2 years
The primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete.
4 secondary outcomes
Number of Days From Treatment Initiation to First Drug Use
Time frame: 6 months
Initiation of Medication Assisted Treatment
Time frame: 6 months
Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score
Time frame: baseline and 6 months
Number of Emergency Room Visits
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Randall T Brown, MD, PhD principal investigator
University of Wisconsin, 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 3 study testing buprenorphine/naloxone 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 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 7 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 26 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With New Crime (time frame: 2 years). 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 7 Jun 2023.