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Giving patients a voice in methadone care: a new approach under the microscope

NCT ID NCT07758439

Knowledge-focused Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This pilot study explores whether a structured approach called shared decision-making can be successfully implemented in a methadone treatment program. Shared decision-making involves clients and healthcare professionals working together to make treatment choices. The study will test the feasibility of this approach, including whether it is acceptable to clients and staff, and whether it can be integrated into routine care. It aims to gather preliminary data to inform a larger future trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Implementation facilitation to support shared decision-making in opioid treatment programs
What this could lead to
If successful, this could pave the way for a larger study that may improve how methadone treatment decisions are made, potentially increasing treatment retention and client satisfaction.
What could go wrong
This is a small pilot study focused on feasibility, not effectiveness. It may not show clear benefits, and results may not apply to other clinics or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Mesa on Main, a single OTP clinic in Arizona operated by Community Medical Services (CMS), will participate as the pilot study site. The investigators will enroll clients and healthcare professionals from Mesa on Main to participate in cross-sectional surveys, qualitative interviews, and EHR data collection.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: CLIENT INCLUSION CRITERIA * Age ≥18 years old * Receiving methadone treatment (i.e., self-report of ingestion of at least one administered or dispensed dose of methadone in past 7 days) at the pilot OTP * Able and willing to provide informed consent * Able to read and write in English or Spanish HEALTHCARE PROFESSIONAL INCLUSION CRITERIA * ≥18 years old * Partners with clients to make methadone treatment decisions (e.g., peer navigator, physician, advanced practice provider, nurse, counselor) * Able and willing to provide informed consent * Able to read and write in English CLIENT EHR INCLUSION CRITERIA * ≥18 years old * Documented receipt of at least one dose of methadone treatment (i.e., administrated or dispensed) from the participating OTP during a 6-month study period SEMI-STRUCTURED INTERVIEW INCLUSION CRITERIA * Clients and healthcare professionals eligible as described above may be included in semi-structured interviews. We will also include the OTP organizational leadership (e.g., clinic director, medical director, regional director). The investigators will purposively sample clients, healthcare professionals, and OTP leadership to contrast positional differences in experiences of SDM and its implementation. The investigators may modify this sampling approach based on preliminary results and advisory board feedback. Exclusion Criteria: CLIENT EXCLUSION CRITERIA * Do not meet client inclusion criteria * For the client survey, each client may complete the survey only once during the 6-month implementation period. HEALTHCARE PROFESSIONAL EXCLUSION CRITERIA * The investigators will exclude healthcare professionals who do not meet inclusion criteria CLIENT EHR EXCLUSION CRITERIA * The investigators will exclude clients who do not meet inclusion criteria SEMI-STRUCTURED INTERVIEW EXCLUSION CRITERIA * The investigators will exclude clients or healthcare professionals who do not meet inclusion criteria.

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Shared decision making

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Community Medical Services Mesa, AZ on Main

    Mesa, Arizona, 85213, United States

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Other studies related to the condition(s) this trial covers.