Improving Treatment for Opioid Use Disorder in CourtsPhase 1/2NCT03229447
Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts
A Phase 1/2 study testing eLearning Modules and Change Team Intervention in people with Improving Treatment for Opioid Use Disorder in Courts, run by National Development and Research Institutes, Inc. at 1 site in United States.
Trial summary
This study compares two methodologies for improving access to medication assisted treatment (MAT) in Ohio courts where MAT is currently restricted or prohibited. All participating courts are asked to view two educational modules. Module 1 addresses the nature of opioid addiction and treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Improving Treatment for Opioid Use Disorder in Courts
- What is being tested?
- eLearning Modules and Change Team Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2016to Apr 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Court Personnel
Who cannot join
- Under 18 years of age
- Not employed by court
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Development and Research Institutes, Inc.
New York, New York, 10010
Andrew Rosenblum, PhD, 212-845-4528, Rosenblum@ndr.org
Harlan Matusow, PhD, 212-845-4445, Matusow@ndri.org
About this study
This study compares two methodologies for improving access to medication assisted treatment (MAT) in Ohio courts where MAT is currently restricted or prohibited. All participating courts are asked to view two educational modules. Module 1 addresses the nature of opioid addiction and treatment. Module 2 addresses concerns specific to criminal justice such as misuse and diversion of medications. Courts selected for the experimental group also receive a hands-on change team initiative in which specially trained professionals work with court staff to provide education and instrumental assistance in order to improve access to MAT for court supervisees who are opioid-dependent.
Read the detailed description
Although there is robust evidence for the efficacy of medication assisted treatment (MAT), e.g., buprenorphine, extended-release naltrexone, methadone, this evidence-based treatment (EBT) is not available for the majority of opioid dependent clients (ODCs) in the criminal justice (CJ) population.
In a recent survey of drug courts our group found that less than half include MAT as a treatment option for their ODCs. Moreover among the minority of courts that do permit MAT, it is typically restricted. Responses by drug court personnel revealed serious concerns about diversion, misuse, and uncertainty about the efficacy of MAT, especially among courts in which MAT was unavailable. Despite these barriers, 70% of the courts indicated that with proper evidence MAT could be considered or expanded as a treatment option. To increase court professionals' understanding of MAT and facilitate decisions on whether MAT would be an appropriate treatment, we proposed a Stage I study to develop and test the feasibility of using an eLearning and an eLearning + a behavioral change team intervention, an Addiction Technology Transfer Center - ATTC - Technology Transfer [TT] model, to advance knowledge and facilitate inclusion of MAT as a treatment option in the criminal justice system (CJS) for ODCs. To enhance the eLearning modality we included testimonials from opinion leaders/early adopters of MAT (e.g., a drug court judge, a representative from the National Association of Drug Court Professionals, and treatment providers) who addressed specific concerns such as methods to identify qualified MAT providers, appraise treatment plans, and prevent and minimize negative effects of diversion and misuse. The behavioral change intervention will be based on a model of process improvement developed by the ATTC Network5 to expand treatment options for the management of opioid dependence, in this case MAT. The planned program represents the first study to: 1) include testimonials by opinion leaders in conjunction with an eLearning approach to spur inclusion of an evidence-based intervention for the treatment of opioid dependence within a criminal justice (CJ) setting and; 2) adapt the ATTC TT model to the specific goal of facilitating inclusion of MAT as a treatment option. Specific aims of the study are:
Aim 1. Develop an eLearning (web-based) intervention that will provide information about risks and benefits of MAT to help drug and felony court staff determine whether MAT is suitable for their clients. The protocol will include group discussions with both MAT-friendly and MAT-averse court personnel and inclusion of a MAT Advisory Panel (MAP), a team of experts in the implementation of MAT in CJ settings. Through an iterative process (review/revisions by MAT experts and court staff) we will develop a consensual outline representing topics that would be addressed by our web-based intervention. The objective will be to provide a balanced, thorough presentation of both benefits and risks of MAT provision and will specifically seek to address concerns about MAT provision such as diversion and misuse. Informed by diffusion of innovations theory, the eLearning modules will be enhanced by including testimony of criminal justice professionals about their experiences with MAT in their courtrooms, what their concerns had been prior to MAT adoption by their court, and how these concerns (and other obstacles that emerged) were addressed.
 Aim 2. Develop a TT intervention to facilitate Courts' readiness and resources to engage in case-by-case inquiries to determine whether and under what circumstances to permit MAT. Working with ATTC TT experts we will develop a change team (CT) intervention for court representatives and treatment providers (including Judge, coordinator, administrator, and case-managers). The objective of the proposed CT intervention will be to: 1) Broker relationships between MAT providers and courts; ensuring that MAT providers will accept court referred individuals; 2) Reinforce the educational objectives - including addressing in substantive ways issues of availability, access (including cost), misuse, and diversion - with court personnel in order to expand policy and practice to include MAT; 3) Work with local MAT and other treatment providers to help create an environment in which MAT is accepted as part of the constellation of available treatments; 4) help develop protocols such as assertive ongoing monitoring and support to assure that MAT benefits are sustained once a client has been referred to treatment.
Aim 3. Conduct a small-scale trial to evaluate the preliminary effectiveness of the eLearning intervention, and the eLearning + change team intervention (TT-intervention). Targeting courts that either do not place their ODCs in MAT or tightly restrict MAT access, 24 courts will be randomly assigned to 1 of 2 treatment conditions: 1. Treatment as usual, followed by the eLearning intervention, or 2. eLearning intervention followed by the CT intervention. Outcomes include 1) the rate of enrollment of clients in MAT; 2) rate of referral of clients to MAT; 3) MAT Knowledge, 4) Willingness to use MAT, and 5) Barriers to MAT. We expect this development/pilot project will lead to a protocol to implement an EBT in the CJS; a setting with high numbers of ODCs.
- Being tested
- eLearning Modules, Change Team Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eLearning ModulesBehavioural
All participating courts will view two eLearning modules. Module one discusses opioid addiction and treatment; module two discusses specific concerns of criminal justice with regard to MAT and ways in which those concerns may be addressed.
Change Team InterventionBehavioural
Courts selected for the experimental condition will participate in a hands-on change team intervention to provide instrumental assistance and to reinforce the information contained in the eLearning modules.
| Study group | Role | What they receive |
|---|---|---|
| E-learning intervention | Active comparator | The E-learning intervention consists of two 20-minute e-learning modules that combine a didactic component with testimonials from respected professionals in the fields of addiction treatment and criminal justice. Module 1 describes the nature of opioid addiction and treatment modalities. Module 2 addresses specific criminal justice concerns of cost, acceptance, usefulness, and diversion, perceived obstacles to providing MAT access as described to us by Ohio criminal justice professionals in formative phase. All courts recruited for the study are exposed to E-Learning. Receives: Behavioral: eLearning Modules |
| Change Team Intervention | Experimental | Half of the courts exposed to e-learning will be randomly assigned to a change team intervention. The change team will reinforce the information in the modules and provide instrumental assistance in linking courts to MAT providers and financial resources. Receives: Behavioral: eLearning Modules; Behavioral: Change Team Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in Medication Assisted Treatment
Pre-post intervention comparison of enrollment in MAT among opioid-dependent supervisees. Using an online survey, investigators compare court-reported data for MAT enrollment.
Measured: 9 months
Secondary outcomes (4)
MAT referrals
Pre-post intervention comparison of referral to MAT for opioid-dependent supervisees. Using an online survey, investigators compare court-reported data for MAT referrals.
Measured: 9 months
MAT knowledge/attitudes
Via online survey, MAT knowledge and attitude scale will be used to test pre-post changes in both knowledge of and attitudes toward MAT.
Measured: 9 months
Willingness to refer clients to MAT
Courts asked how receptive they are to refer clients to MAT. Using an online survey, investigators ask judges to elaborate upon their willingness to refer clients to MAT.
Measured: 9 months
Barriers to MAT
Courts complete a checklist of structural barriers such as cost, policy opposition, availability. Using an online survey, investigators compare court-reported data for barriers to MAT referral.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start15 Apr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Treatment for Opioid Use Disorder in CourtsStudies 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
- Model description
- This study will develop and test the feasibility of an interactive eLearning modality and an eLearning + an organizational approach (change team intervention; a Technology Transfer model) to advance knowledge and facilitate inclusion of MAT in the criminal justice system for opioid-addicted clients. Courts recruited for the study will receive eLearning and half of these courts will be randomly assigned to the change team.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Treatment Alternatives for Safe Communities
- Responsible party
- Sponsor
- Investigators
- Andrew Rosenblum, Principal investigator, Executive Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229447
- Sponsor's protocol ID
- NationalDRI
- Other IDs
- R34DA038799
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts
- ClinicalTrials.gov ID
- NCT03229447
- Acronym / sponsor ID
- NationalDRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- Treatment Alternatives for Safe Communities
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 25 Jul 2017 (actual)
- 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 study compares two methodologies for improving access to medication assisted treatment (MAT) in Ohio courts where MAT is currently restricted or prohibited. All participating courts are asked to view two educational modules. Module 1 addresses the nature of opioid addiction and treatment. Module 2 addresses concerns specific to criminal justice such as misuse and diversion of medications. Courts selected for the experimental group also receive a hands-on change team initiative in which specially trained professionals work with court staff to provide education and instrumental assistance in order to improve access to MAT for court supervisees who are opioid-dependent.
Detailed description
Although there is robust evidence for the efficacy of medication assisted treatment (MAT), e.g., buprenorphine, extended-release naltrexone, methadone, this evidence-based treatment (EBT) is not available for the majority of opioid dependent clients (ODCs) in the criminal justice (CJ) population.
In a recent survey of drug courts our group found that less than half include MAT as a treatment option for their ODCs. Moreover among the minority of courts that do permit MAT, it is typically restricted. Responses by drug court personnel revealed serious concerns about diversion, misuse, and uncertainty about the efficacy of MAT, especially among courts in which MAT was unavailable. Despite these barriers, 70% of the courts indicated that with proper evidence MAT could be considered or expanded as a treatment option. To increase court professionals' understanding of MAT and facilitate decisions on whether MAT would be an appropriate treatment, we proposed a Stage I study to develop and test the feasibility of using an eLearning and an eLearning + a behavioral change team intervention, an Addiction Technology Transfer Center - ATTC - Technology Transfer [TT] model, to advance knowledge and facilitate inclusion of MAT as a treatment option in the criminal justice system (CJS) for ODCs. To enhance the eLearning modality we included testimonials from opinion leaders/early adopters of MAT (e.g., a drug court judge, a representative from the National Association of Drug Court Professionals, and treatment providers) who addressed specific concerns such as methods to identify qualified MAT providers, appraise treatment plans, and prevent and minimize negative effects of diversion and misuse. The behavioral change intervention will be based on a model of process improvement developed by the ATTC Network5 to expand treatment options for the management of opioid dependence, in this case MAT. The planned program represents the first study to: 1) include testimonials by opinion leaders in conjunction with an eLearning approach to spur inclusion of an evidence-based intervention for the treatment of opioid dependence within a criminal justice (CJ) setting and; 2) adapt the ATTC TT model to the specific goal of facilitating inclusion of MAT as a treatment option. Specific aims of the study are:
Aim 1. Develop an eLearning (web-based) intervention that will provide information about risks and benefits of MAT to help drug and felony court staff determine whether MAT is suitable for their clients. The protocol will include group discussions with both MAT-friendly and MAT-averse court personnel and inclusion of a MAT Advisory Panel (MAP), a team of experts in the implementation of MAT in CJ settings. Through an iterative process (review/revisions by MAT experts and court staff) we will develop a consensual outline representing topics that would be addressed by our web-based intervention. The objective will be to provide a balanced, thorough presentation of both benefits and risks of MAT provision and will specifically seek to address concerns about MAT provision such as diversion and misuse. Informed by diffusion of innovations theory, the eLearning modules will be enhanced by including testimony of criminal justice professionals about their experiences with MAT in their courtrooms, what their concerns had been prior to MAT adoption by their court, and how these concerns (and other obstacles that emerged) were addressed.
 Aim 2. Develop a TT intervention to facilitate Courts' readiness and resources to engage in case-by-case inquiries to determine whether and under what circumstances to permit MAT. Working with ATTC TT experts we will develop a change team (CT) intervention for court representatives and treatment providers (including Judge, coordinator, administrator, and case-managers). The objective of the proposed CT intervention will be to: 1) Broker relationships between MAT providers and courts; ensuring that MAT providers will accept court referred individuals; 2) Reinforce the educational objectives - including addressing in substantive ways issues of availability, access (including cost), misuse, and diversion - with court personnel in order to expand policy and practice to include MAT; 3) Work with local MAT and other treatment providers to help create an environment in which MAT is accepted as part of the constellation of available treatments; 4) help develop protocols such as assertive ongoing monitoring and support to assure that MAT benefits are sustained once a client has been referred to treatment.
Aim 3. Conduct a small-scale trial to evaluate the preliminary effectiveness of the eLearning intervention, and the eLearning + change team intervention (TT-intervention). Targeting courts that either do not place their ODCs in MAT or tightly restrict MAT access, 24 courts will be randomly assigned to 1 of 2 treatment conditions: 1. Treatment as usual, followed by the eLearning intervention, or 2. eLearning intervention followed by the CT intervention. Outcomes include 1) the rate of enrollment of clients in MAT; 2) rate of referral of clients to MAT; 3) MAT Knowledge, 4) Willingness to use MAT, and 5) Barriers to MAT. We expect this development/pilot project will lead to a protocol to implement an EBT in the CJS; a setting with high numbers of ODCs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will develop and test the feasibility of an interactive eLearning modality and an eLearning + an organizational approach (change team intervention; a Technology Transfer model) to advance knowledge and facilitate inclusion of MAT in the criminal justice system for opioid-addicted clients. Courts recruited for the study will receive eLearning and half of these courts will be randomly assigned to the change team.
| Arm | Type | Receives |
|---|---|---|
| E-learning intervention | Active comparator | Behavioral: eLearning ModulesThe E-learning intervention consists of two 20-minute e-learning modules that combine a didactic component with testimonials from respected professionals in the fields of addiction treatment and criminal justice. Module 1 describes the nature of opioid addiction and treatment modalities. Module 2 addresses specific criminal justice concerns of cost, acceptance, usefulness, and diversion, perceived obstacles to providing MAT access as described to us by Ohio criminal justice professionals in formative phase. All courts recruited for the study are exposed to E-Learning. |
| Change Team Intervention | Experimental | Behavioral: eLearning Modules, Behavioral: Change Team InterventionHalf of the courts exposed to e-learning will be randomly assigned to a change team intervention. The change team will reinforce the information in the modules and provide instrumental assistance in linking courts to MAT providers and financial resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years of age
- Court Personnel
Key exclusion criteria (2 listed)
- Under 18 years of age
- Not employed by court
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 |
|---|---|---|
| eLearning ModulesAll participating courts will view two eLearning modules. Module one discusses opioid addiction and treatment; module two discusses specific concerns of criminal justice with regard to MAT and ways in which those concerns may be addressed. | Behavioural | Change Team Intervention, E-learning intervention |
| Change Team InterventionCourts selected for the experimental condition will participate in a hands-on change team intervention to provide instrumental assistance and to reinforce the information contained in the eLearning modules. | Behavioural | Change Team Intervention |
Primary outcome
Enrollment in Medication Assisted Treatment
Time frame: 9 months
Pre-post intervention comparison of enrollment in MAT among opioid-dependent supervisees. Using an online survey, investigators compare court-reported data for MAT enrollment.
4 secondary outcomes
MAT referrals
Time frame: 9 months
MAT knowledge/attitudes
Time frame: 9 months
Willingness to refer clients to MAT
Time frame: 9 months
Barriers to MAT
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Individual participant dataSharing planned: No
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.
Andrew Rosenblum principal investigator
Executive Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing eLearning Modules and Change Team Intervention in people with Improving Treatment for Opioid Use Disorder in Courts, run by National Development and Research Institutes, Inc. 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 2 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 25 Jul 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Rosenblum, PhD (2128454258, rosenblum@ndri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment in Medication Assisted Treatment (time frame: 9 months). 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 25 Jul 2017.