47 Participants Needed

Implementation Strategies for Medication-Assisted Treatment for Opioid Addiction

(SITT-MAT Trial)

HC
HC
Overseen ByHelene Chokron Garneau, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
Must be taking: MOUD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to expand access to medications for opioid use disorder (MOUD) in specialty addiction programs in Washington State. Sixty-four addiction treatment programs will participate in an adaptive implementation strategy trial that uses a stagewise implementation-to-target (stepped "care" type) approach whereby organizations engage in increasingly intensive implementation strategies as needed. Organizations are moved to a follow-up/sustainment arm once they have met the implementation targets described below. The design also includes an external comparator arm, which consists of 510 addiction treatment programs that are not participating in the study and will mimic as study controls.The sequence of implementation strategies are:1. Enhanced Monitoring and Feedback2. NIATx/MAT Academy3. Randomization to either NIATx Internal Facilitation or NIATx External Facilitation4. Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation armImplementation targets are:1. Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months2. Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD3. Implementation - a total score ≥ 4 on the Integrating Medications for Addiction Treatment (IMAT) Index.Contextual moderators and mediators of performance on target outcomes as a function of the implementation strategy step will be examined, as will the costs associated with participation in the sequence of implementation strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It focuses on expanding access to medications for opioid use disorder in treatment programs.

Is medication-assisted treatment for opioid addiction safe for humans?

The safety of medication-assisted treatment (MAT) for opioid addiction has been evaluated in various studies. For example, a study on naltrexone, a medication used in MAT, showed that it was generally well-tolerated by patients with heroin addiction. Additionally, a digital therapeutic adjunct to buprenorphine, another MAT medication, was evaluated for safety in a clinical trial, indicating that these treatments are generally safe for human use.12345

How does the Enhanced Monitoring and Feedback (EMF) treatment for opioid addiction differ from other treatments?

The Enhanced Monitoring and Feedback (EMF) treatment is unique because it incorporates strategies like motivational coaching and adherence monitoring through digital platforms, which can improve patient engagement and treatment adherence compared to traditional medication-assisted treatments.46789

What data supports the effectiveness of this treatment for opioid addiction?

The NIATx approach, which is part of the treatment strategies being studied, has been shown to improve access to and retention in addiction treatment programs by reducing the time to start treatment and increasing the number of patients who continue with their care. This suggests that similar strategies could be effective in supporting medication-assisted treatment for opioid addiction.46101112

Who Is on the Research Team?

MM

Mark McGovern, PhD

Principal Investigator

Stanford University

JH

James H Ford II, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for addiction treatment programs in Washington State that handle opioid use disorder but are not opioid treatment programs. It includes residential detox or rehab, outpatient services, primary care clinics like FQHCs and CHCs.

Inclusion Criteria

Primary care clinics, including Federally Qualified Health Centers (FQHCs) and Community Health Centers (CHCs)
I am currently in a detox, rehab, or outpatient care program.
Addiction treatment programs in Washington State

Exclusion Criteria

Opioid treatment programs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enhanced Monitoring and Feedback

Organizations engage in enhanced monitoring and feedback to improve MOUD implementation

3 months

NIATx/MAT Academy

Organizations participate in NIATx/MAT Academy to enhance MOUD implementation strategies

3 months

Facilitation

Randomization to either NIATx Internal Facilitation or NIATx External Facilitation, with potential reassignment to External Facilitation if targets are not met

3-6 months

Follow-up/Sustainment

Organizations are moved to a follow-up/sustainment arm once they have met the implementation targets

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Monitoring and Feedback (EMF)
  • NIATx-External Facilitation (NIATx-EF)
  • NIATx-Internal Facilitation (NIATx-IF)
  • NIATx/MAT Academy
Trial Overview The study tests a stagewise approach to implementing medications for opioid use disorder (MOUD) across various addiction programs. Strategies include Enhanced Monitoring and Feedback, NIATx/MAT Academy, and randomization between two types of facilitation methods with goals of reaching specific implementation targets.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Path 5Experimental Treatment4 Interventions
Group II: Path 4Experimental Treatment3 Interventions
Group III: Path 3Experimental Treatment3 Interventions
Group IV: Path 2Experimental Treatment2 Interventions
Group V: Path 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

University of Wisconsin, Madison

Collaborator

Trials
1,249
Recruited
3,255,000+

Washington State Health Care Authority

Collaborator

Trials
1
Recruited
50+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.
Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.
Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial.Janzow, GE., Harding, C., Flores, M., et al.[2023]
A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.
Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.
Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study.Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]
A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.
Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.
Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain.Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

Citations

Improving care for the treatment of alcohol and drug disorders. [2021]
Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. [2023]
Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]
The Network for the Improvement of Addiction Treatment (NIATx): enhancing access and retention. [2019]
Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]
Naltrexone for heroin addiction: encouraging results from Italy. [2013]
Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study. [2022]
Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]
Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Trends in Abstinence and Retention Associated with a Medication-Assisted Treatment Program for People with Opioid Use Disorders. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Medication-assisted treatment of opioid use disorder: review of the evidence and future directions. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Perceived Ability to Treat Opioid Use Disorder in West Virginia. [2022]
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