Status:
COMPLETED
PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
16-90 years
Phase:
NA
Brief Summary
Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for treating OUDs-buprenorphine and injectable naltrexone-can be prescribed in primary care (PC). However, des...
Eligibility Criteria
Inclusion
- 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:
- Age is 16 to 90 years at any time during the study; and
- 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
- Patients who have requested through their health systems to opt out of research will be excluded from this study.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2020
Estimated Enrollment :
973759 Patients enrolled
Trial Details
Trial ID
NCT03407638
Start Date
February 28 2018
End Date
February 29 2020
Last Update
May 18 2025
Active Locations (6)
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1
University of Miami Health System
Miami, Florida, United States, 33136
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
3
Montefiore Medical Center
The Bronx, New York, United States, 10467
4
Harris Health System
Houston, Texas, United States, 77054