Implementation Strategies for Medication-Assisted Treatment for Opioid Addiction

(SITT-MAT Trial)

Overseen By Helene Chokron Garneau, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: MOUD

Disqualifiers: Opioid treatment programs

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods for helping addiction programs in Washington State provide medication for opioid addiction. The study tests various strategies, such as Enhanced Monitoring and Feedback (EMF) and specialized staff training through programs like NIATx-External Facilitation (NIATx-EF) and NIATx-Internal Facilitation (NIATx-IF), to determine the most effective approach for ensuring patients receive necessary medication. It involves multiple steps, beginning with basic support and adding further assistance as needed. This trial suits addiction treatment programs in Washington that offer residential or outpatient care but not those solely focused on opioid treatment. As an unphased trial, it presents a unique opportunity to enhance addiction treatment strategies within the community.

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.

What prior data suggests that these implementation strategies are safe for expanding access to medications for opioid use disorder?

Research has shown that the safety of the treatments in this trial has been studied before. Enhanced Monitoring and Feedback, one of the strategies, has been used in primary care clinics. These clinics found it helpful for tracking and improving the use of medications for opioid use disorder (MOUD). The sources reviewed show no evidence of harm or safety issues from this approach.

The NIATx/MAT Academy and its related strategies, which include both external and internal support, are also under study. Over 60 studies support the NIATx model, demonstrating its effectiveness in helping clinics adopt new practices. This suggests it is a safe way to improve access to treatments like MOUD.

Overall, these treatments aim to help clinics provide MOUD more effectively. The sources reviewed do not mention any safety problems, suggesting these approaches are generally well-tolerated. However, since the trial phase is "Not Applicable," detailed safety data might not be available yet. This indicates the strategies are likely safe, but ongoing research will provide more evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to enhance how medication-assisted treatments (MAT) for opioid addiction are implemented. Unlike traditional approaches that often rely on standard counseling and medication regimens, this trial introduces several strategies like Enhanced Monitoring and Feedback (EMF) and the NIATx/MAT Academy. These methods aim to improve treatment outcomes by offering more personalized feedback and structured training for providers. By examining different combinations, such as adding Internal or External Facilitation, the trial seeks to uncover the most effective ways to support patients and healthcare providers, potentially leading to more successful recovery journeys for those battling opioid addiction.

What evidence suggests that this trial's treatments could be effective for opioid addiction?

Research shows that Medication-Assisted Treatment (MAT) effectively addresses opioid use disorder (OUD). Studies have found that MAT significantly reduces deaths from opioid overdoses. In this trial, participants will follow different paths that include various combinations of strategies. The NIATx model, included in some trial paths, has support from over 60 studies proving its effectiveness in improving addiction treatment programs. Enhanced Monitoring and Feedback, another strategy in the trial, uses large amounts of data and shows promise in helping people remain in MAT programs longer. Together, these strategies aim to make effective treatments for OUD more accessible in specialized programs. ^{3 4 5 6 7}

Who Is on the Research Team?

James H Ford II, PhD

Principal Investigator

University of Wisconsin, Madison

Mark McGovern, PhD

Principal Investigator

Stanford University

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?

Group I: Path 5 Experimental Treatment 4 Interventions

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation

Group II: Path 4 Experimental Treatment 3 Interventions

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation

Group III: Path 3 Experimental Treatment 3 Interventions

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation

Group IV: Path 2 Experimental Treatment 2 Interventions

Enhanced Monitoring and Feedback + NIATx/MAT Academy

Group V: Path 1 Experimental Treatment 1 Intervention

Enhanced Monitoring and Feedback

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

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

The ORION tool, an innovative e-health psychoeducational software, was developed to inform opioid-dependent individuals about overdose risks and identified seven key risk factors related to their behaviors.

While the ORION tool did not significantly change self-efficacy scores in participants, it effectively identified those at higher risk, suggesting that it could be a valuable component of a broader intervention strategy when combined with other support methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study. Carrà, G., Crocamo, C., Humphris, G., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The tailored telephone intervention delivered by peers (TTIP-PRO) was well-received by participants, with all eight patients finding it 'very helpful' and showing a significant increase in their knowledge about opioid overdoses, from 69.9% to 93.6% correct responses after the intervention.

While interest in starting medication-assisted treatment (MAT) increased from 8.1 to 9.5 on a 10-point scale, this change was not statistically significant, indicating that further development and testing of TTIP-PRO is needed to effectively encourage MAT enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). Winhusen, T., Theobald, J., Lewis, D., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9705076/

Using Data Science to Improve Outcomes for Persons with ... Data science may be valuable and promising for improving MOUD retention by using “big data” (eg, electronic health record data, claims data mobile/sensor data, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590019300343

Effectiveness of Prescription Monitoring Programs in ... We found limited, but inconsistent, evidence that PMPs were associated with reduced schedule II opioid prescribing and dispensing, as well as multiple provider ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6437666/

Prescription Drug Monitoring Programs and Opioid ... Our results are consistent with the hypothesis that prescription drug monitoring programs are most effective in areas where people are likely to access opioids ...

4. cdc.gov cdc.gov/nchs/data/series/sr_02/sr2-188.pdf

Enhancing Identification of Opioid-involved Health ... This report documents the development of the 2016. National Hospital Care Survey (NHCS) Enhanced Opioid. Identification Algorithm, an algorithm that can be used.

5. mhealth.jmir.org mhealth.jmir.org/2024/1/e49751

Users' Acceptability and Perceived Efficacy of mHealth for ... This study aims to synthesize qualitative insights into opioid users' acceptability and perceived efficacy of mHealth and wearable technologies for opioid use ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9258188/

Expanding access to medications for opioid use disorder in ... Forty-one primary care clinics were offered access to four implementation strategies: (1) Enhanced Monitoring and Feedback, (2) Learning Collaboratives, (3) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7489858/

Assessment of Probable Opioid Use Disorder ... This cross-sectional study demonstrated that DSM-5 criteria for opioid use disorder can be extracted through review of electronic health records.