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Can primary care clinics help curb the opioid crisis? a major trial tests a Team-Based model

NCT ID NCT03407638

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether a team-based approach, including a dedicated nurse care manager, can help primary care clinics provide medication treatment for opioid use disorder. The study involves 12 clinics across five U.S. states, with half using the new approach and half continuing usual care. Researchers will measure whether more patients receive and stay on treatment, and whether this reduces emergency room visits and hospital stays.

What this could mean

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

Active substance
buprenorphine or injectable naltrexone
What this could lead to
If successful, this could show that a team-based primary care model is an effective way to expand access to opioid use disorder treatment, potentially reducing overdoses and hospital visits.
What could go wrong
This is an implementation trial, not a test of the medications themselves. Results may vary across different health systems, and the intervention may not be adopted widely if it proves too costly or complex.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

377,373 people

The number who actually took part.

Started

Feb 2018

Finished

Feb 2020

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.

Ages

16 to 90 years

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: * The 12 clinics were eligible if their health system leaders agreed they would participate prior to study start. Patients are eligible for inclusion in the sample for analyses of the PROUD trial if they visited one of the randomized clinics at any time in the 5 year study period. Specific inclusion criteria for the trial are: 1. Age is 16 to 90 years at any time during the study; and 2. Visited a PROUD trial primary care clinic in the 3 years prior to randomization or the 2 years after (note: one of the 6 study sites may only be able to provide EHR data for 2 years before randomization) Exclusion Criteria: * Patients who have requested through their health systems to opt out of research will be excluded from this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Harris Health System

    Houston, Texas, 77054, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Kaiser Permanente Washington

    Seattle, Washington, 98112, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • MultiCare Health System

    Tacoma, Washington, 98405, United States

  • University of Miami Health System

    Miami, Florida, 33136, United States

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