Addiction, OpioidSITT-MATNCT05343793

Stagewise Implementation-To-Target- Medications for Addiction Treatment (SITT-MAT)

A study testing Enhanced Monitoring and Feedback (EMF), NIATx/MAT Academy and NIATx-Internal Facilitation (NIATx-IF) in people with Addiction, Opioid, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Addiction, Opioid
What is being tested?: Enhanced Monitoring and Feedback (EMF), NIATx/MAT Academy and NIATx-Internal Facilitation (NIATx-IF)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 14 Mar 2022to 30 Jun 2026
Phase: Interventional
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

Addiction treatment programs in Washington State
Residential (detoxification or rehabilitation) or outpatient (intensive outpatient or outpatient) levels of care
Primary care clinics, including Federally Qualified Health Centers (FQHCs) and Community Health Centers (CHCs)

Who cannot join

Opioid treatment programs

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington State Healthcare Authority
Olympia, Washington, 98501

Other trials in United States

About this study

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:

Enhanced Monitoring and Feedback
NIATx/MAT Academy
Randomization to either NIATx Internal Facilitation or NIATx External Facilitation
Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation arm

Implementation targets are:

Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months
Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD
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.

Read the detailed description

Principal Investigator: Mark McGovern, PhD, Stanford University; Principal Investigator: James H Ford II, PhD, University of Wisconsin, Madison; Site Principal Investigator: Tony Walton, MS, Washington State Health Care Authority

Conditions: Addiction, Opioid
Being tested: Enhanced Monitoring and Feedback (EMF), NIATx/MAT Academy, NIATx-Internal Facilitation (NIATx-IF), NIATx-External Facilitation (NIATx-EF)
Keywords: Implementation strategies, Medications for opioid use disorder
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.

Enhanced Monitoring and Feedback (EMF)Other
Enhanced Monitoring and Feedback consists of performance data (reach, adoption, effectiveness, implementation) gathered and reported by the program on a quarterly basis. Data summaries for each program and in comparison to the entire sample, will be reflected back to participants, via dashboards, within one-month of data submission.
NIATx/MAT AcademyOther
This two-day workshop will provide participating clinics with rationale, clinical practice and program integration with MOUD (Day 1), and an overview of NIATx principles and tools (Day 2).
NIATx-Internal Facilitation (NIATx-IF)Other
Internal facilitators will receive training (in-person or online) on how to provide coaching within their organization. For 9-months, Internal Facilitators (IFs) will: a) support teams to harness resources toward systemic change and improvement; b) employ a range of concepts and tools to provide individualized support to teams; c) help teams to practice and hone their skills to optimize performance, and d) focus on team relationships and communications.
NIATx-External Facilitation (NIATx-EF)Other
For 9-months, organizations in the NIATx-EF study arm will work with one of 4 experienced consultant NIATx External Facilitators (EFs). The EF meets with clinic staff to plan change projects, review ongoing change efforts, discuss successes, and offer guidance on planning future change projects using PDSA cycles. The EF makes a 1-day site visit during the 1st quarter of the implementation period and leads monthly 1-hour phone calls.

Study groups in NCT05343793
Study group	Role	What they receive
Path 1	Experimental	Enhanced Monitoring and Feedback Receives: Other: Enhanced Monitoring and Feedback (EMF)
Path 2	Experimental	Enhanced Monitoring and Feedback + NIATx/MAT Academy Receives: Other: Enhanced Monitoring and Feedback (EMF); Other: NIATx/MAT Academy
Path 3	Experimental	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation Receives: Other: Enhanced Monitoring and Feedback (EMF); Other: NIATx/MAT Academy; Other: NIATx-External Facilitation (NIATx-EF)
Path 4	Experimental	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation Receives: Other: Enhanced Monitoring and Feedback (EMF); Other: NIATx/MAT Academy; Other: NIATx-Internal Facilitation (NIATx-IF)
Path 5	Experimental	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation Receives: Other: Enhanced Monitoring and Feedback (EMF); Other: NIATx/MAT Academy; Other: NIATx-Internal Facilitation (NIATx-IF); Other: NIATx-External Facilitation (NIATx-EF)

What is being measured

The primary outcome is the main question the study is designed to answer.

Reach
The proportion of program patients with OUD and receiving MOUD (buprenorphine, naltrexone) within the index quarter.
Measured: Quarterly ; Months 1 to 46
Adoption
The number of integrated prescribers of buprenorphine and/or naltrexone, who are actively prescribing MOUD.
Measured: Quarterly ; Months 1 to 46
Effectiveness
Access: The proportion of patients prescribed MOUD who start the medication within 72 hours of diagnosis. For patients requiring detoxification for naltrexone, Access will be operationalized as the proportion of patients who start the medication within 72 hours of when it is safe or indicated by a physician. Retention: The proportion of patients who are retained in continuous care for at least 6-months from the start of medication, or if in time limited care situations (e.g., residential detoxification) for the entire treatment episode.
Measured: Quarterly ; Months 1 to 46
Implementation - Integrating Medications for Addiction Treatment (IMAT) Index
The IMAT integrates MOUD guidelines, expert consensus recommendations, the OUD care cascade, and best practice information into a team-assessment benchmark measure of current and future state MOUD capability and practice. The IMAT is composed of 45 items, rated on a 1 to 5 scale from: 1- Not Integrated, to 3- Partially integrated, to 5- Fully integrated. Intermediate ratings of 2 and 4, are ratings not at either a 3 or 5 level respectively. The benchmark items address policy, practice and workforce factors, and are clustered into seven dimensions of: 1) Infrastructure; 2) Clinic culture and environment; 3) Patient identification and initiating care; 4) Care delivery and treatment response monitoring; 5) Care coordination; 6) Workforce; and, 7) Staff training and development. The IMAT Total Score is a composite rating from 1 to 5 of overall MOUD care quality. It takes between 1 to 2 hours to complete.
Measured: Months 1,7,14,24,34,46

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 202230 Jun 2026

First posted25 Apr 2022
Study start14 Mar 2022
Primary completion30 Jun 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Addiction, OpioidStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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 N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05343793
Sponsor's protocol ID: 60711
Other IDs: 1R01DA052975-01A1
Acronym: SITT-MAT
Status last verified: Jun 2026
First submitted: 6 Apr 2022
Last updated: 28 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jaros S, Magid MA, Cheng H, Gassman M, Garneau HC, Ford Ii JH, McGovern M. A mixed methods analysis of clinics' perspectives on community factors influencing access to medications for opioid use disorder. Addict Sci Clin Pract. 2026 Jan 8;21(1):10. doi: 10.1186/s13722-025-00643-1.
PubMed 41508111
Cheng H, Abdel Magid M, McGovern MP, Ford JH 2nd, Manja V, Chokron Garneau H, Wagner TH. A pragmatic approach to estimating the cost to deliver and participate in implementation strategies. Implement Sci. 2025 Oct 17;20(1):44. doi: 10.1186/s13012-025-01459-y.
PubMed 41107954
Ford JH 2nd, Cheng H, Gassman M, Fontaine H, Garneau HC, Keith R, Michael E, McGovern MP. Stepped implementation-to-target: a study protocol of an adaptive trial to expand access to addiction medications. Implement Sci. 2022 Sep 29;17(1):64. doi: 10.1186/s13012-022-01239-y.
PubMed 36175963

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stagewise Implementation-To-Target- Medications for Addiction Treatment (SITT-MAT)
ClinicalTrials.gov ID: NCT05343793
Acronym / sponsor ID: SITT-MAT / 60711
Conditions: Addiction, Opioid
Keywords: Implementation strategies, Medications for opioid use disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: University of Wisconsin, Madison, National Institute on Drug Abuse (NIDA), Washington State Health Care Authority
Study start: 14 Mar 2022 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 25 Apr 2022 (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.

The sequence of implementation strategies are:

Enhanced Monitoring and Feedback
NIATx/MAT Academy
Randomization to either NIATx Internal Facilitation or NIATx External Facilitation
Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation arm

Implementation targets are:

Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months
Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD
Implementation - a total score ≥ 4 on the Integrating Medications for Addiction Treatment (IMAT) Index.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Path 1	Experimental	Other: Enhanced Monitoring and Feedback (EMF)Enhanced Monitoring and Feedback
Path 2	Experimental	Other: Enhanced Monitoring and Feedback (EMF), Other: NIATx/MAT AcademyEnhanced Monitoring and Feedback + NIATx/MAT Academy
Path 3	Experimental	Other: Enhanced Monitoring and Feedback (EMF), Other: NIATx/MAT Academy, Other: NIATx-External Facilitation (NIATx-EF)Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation
Path 4	Experimental	Other: Enhanced Monitoring and Feedback (EMF), Other: NIATx/MAT Academy, Other: NIATx-Internal Facilitation (NIATx-IF)Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation
Path 5	Experimental	Other: Enhanced Monitoring and Feedback (EMF), Other: NIATx/MAT Academy, Other: NIATx-Internal Facilitation (NIATx-IF), Other: NIATx-External Facilitation (NIATx-EF)Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Addiction treatment programs in Washington State
Residential (detoxification or rehabilitation) or outpatient (intensive outpatient or outpatient) levels of care
Primary care clinics, including Federally Qualified Health Centers (FQHCs) and Community Health Centers (CHCs)

Key exclusion criteria (1 listed)

Opioid treatment programs

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
Enhanced Monitoring and Feedback (EMF)Enhanced Monitoring and Feedback consists of performance data (reach, adoption, effectiveness, implementation) gathered and reported by the program on a quarterly basis. Data summaries for each program and in comparison to the entire sample, will be reflected back to participants, via dashboards, within one-month of data submission.	Other	Path 1, Path 2, Path 3, Path 4, Path 5
NIATx/MAT AcademyThis two-day workshop will provide participating clinics with rationale, clinical practice and program integration with MOUD (Day 1), and an overview of NIATx principles and tools (Day 2).	Other	Path 2, Path 3, Path 4, Path 5
NIATx-Internal Facilitation (NIATx-IF)Internal facilitators will receive training (in-person or online) on how to provide coaching within their organization. For 9-months, Internal Facilitators (IFs) will: a) support teams to harness resources toward systemic change and improvement; b) employ a range of concepts and tools to provide individualized support to teams; c) help teams to practice and hone their skills to optimize performance, and d) focus on team relationships and communications.	Other	Path 4, Path 5
NIATx-External Facilitation (NIATx-EF)For 9-months, organizations in the NIATx-EF study arm will work with one of 4 experienced consultant NIATx External Facilitators (EFs). The EF meets with clinic staff to plan change projects, review ongoing change efforts, discuss successes, and offer guidance on planning future change projects using PDSA cycles. The EF makes a 1-day site visit during the 1st quarter of the implementation period and leads monthly 1-hour phone calls.	Other	Path 3, Path 5

Primary outcome

Reach
Time frame: Quarterly ; Months 1 to 46
The proportion of program patients with OUD and receiving MOUD (buprenorphine, naltrexone) within the index quarter.
Adoption
Time frame: Quarterly ; Months 1 to 46
The number of integrated prescribers of buprenorphine and/or naltrexone, who are actively prescribing MOUD.
Effectiveness
Time frame: Quarterly ; Months 1 to 46
Access: The proportion of patients prescribed MOUD who start the medication within 72 hours of diagnosis. For patients requiring detoxification for naltrexone, Access will be operationalized as the proportion of patients who start the medication within 72 hours of when it is safe or indicated by a physician. Retention: The proportion of patients who are retained in continuous care for at least 6-months from the start of medication, or if in time limited care situations (e.g., residential detoxification) for the entire treatment episode.
Implementation - Integrating Medications for Addiction Treatment (IMAT) Index
Time frame: Months 1,7,14,24,34,46
The IMAT integrates MOUD guidelines, expert consensus recommendations, the OUD care cascade, and best practice information into a team-assessment benchmark measure of current and future state MOUD capability and practice. The IMAT is composed of 45 items, rated on a 1 to 5 scale from: 1- Not Integrated, to 3- Partially integrated, to 5- Fully integrated. Intermediate ratings of 2 and 4, are ratings not at either a 3 or 5 level respectively. The benchmark items address policy, practice and workforce factors, and are clustered into seven dimensions of: 1) Infrastructure; 2) Clinic culture and environment; 3) Patient identification and initiating care; 4) Care delivery and treatment response monitoring; 5) Care coordination; 6) Workforce; and, 7) Staff training and development. The IMAT Total Score is a composite rating from 1 to 5 of overall MOUD care quality. It takes between 1 to 2 hours to complete.

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 28 Jul 2026.
Derived from this study: PubMed 41508111Jaros S, Magid MA, Cheng H, Gassman M, Garneau HC, Ford Ii JH, McGovern M. A mixed methods analysis of clinics' perspectives on community factors influencing access to medications for opioid use disorder. Addict Sci Clin Pract. 2026 Jan 8;21(1):10. doi: 10.1186/s13722-025-00643-1.
Derived from this study: PubMed 41107954Cheng H, Abdel Magid M, McGovern MP, Ford JH 2nd, Manja V, Chokron Garneau H, Wagner TH. A pragmatic approach to estimating the cost to deliver and participate in implementation strategies. Implement Sci. 2025 Oct 17;20(1):44. doi: 10.1186/s13012-025-01459-y.
Derived from this study: PubMed 36175963Ford JH 2nd, Cheng H, Gassman M, Fontaine H, Garneau HC, Keith R, Michael E, McGovern MP. Stepped implementation-to-target: a study protocol of an adaptive trial to expand access to addiction medications. Implement Sci. 2022 Sep 29;17(1):64. doi: 10.1186/s13012-022-01239-y.
Individual participant dataSharing planned: No

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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.

Mark McGovern, PhD principal investigator

Stanford University

James H Ford II, PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 1 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 28 Jul 2026. 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.

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?

Reach (time frame: Quarterly ; Months 1 to 46). The study lists 4 primary outcomes in all. 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 NCT05343793, which also lists 3 linked publications.

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 28 Jul 2026.