Can primary care clinics help curb the opioid crisis? a major trial tests a Team-Based model
NCT ID NCT03407638
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
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377,373 people
The number who actually took part.
- Started
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Feb 2018
- Finished
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Feb 2020
- Lead sponsor
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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
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Kaiser Permanente Washington
Seattle, Washington, 98112, United States
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Montefiore Medical Center
The Bronx, New York, 10467, United States
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MultiCare Health System
Tacoma, Washington, 98405, United States
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University of Miami Health System
Miami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.
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