Opioid-use DisorderPROUDNCT03407638
PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
A study testing PROUD Intervention in people with Opioid-use Disorder, run by Kaiser Permanente at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- PROUD Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377,373 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Feb 2018to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients who have requested through their health systems to opt out of research will be excluded from this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Henry Ford Health System
Detroit, Michigan, 48202
Harris Health System
Houston, Texas, 77054
University of Miami Health System
Miami, Florida, 33136
Kaiser Permanente Washington
Seattle, Washington, 98112
MultiCare Health System
Tacoma, Washington, 98405
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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, despite the current opioid epidemic and expert recommendations that OUDs should be treated in PC, most PC clinics do not offer treatment for OUDs. This reflects a lack of consensus among health system leaders and clinicians that OUDs should be treated in PC.
The PRimary care Opioid Use Disorders treatment (PROUD) Trial is a pragmatic cluster-randomized, quality improvement trial that evaluates implementation of a team-based approach to PC supported by a full time nurse (the "PROUD intervention"). This type of team-based PC is often referred to as "collaborative care" for management of OUDs in PC, and this type of trial is often referred to as a Hybrid Type III implementation trial.
Read more
The trial is being conducted in 6 diverse health systems spanning 5 states (New York, Florida, Michigan, Texas, and Washington), with 2 PC clinics in each system randomized. One clinic is randomly selected to implement the PROUD intervention and the other continues usual PC (UPC).
The overall objective of the PROUD trial is to provide information to guide health system leaders who are faced with the decision of whether or not to treat OUDs in PC, by evaluating the benefits of implementing the PROUD intervention that integrates high quality OUD treatment (i.e. buprenorphine or injectable naltrexone) into the normal flow of PC.
The primary objective of the PROUD trial is to evaluate whether the PROUD intervention increases OUD treatment with buprenorphine or injectable naltrexone, documented in the electronic health records (EHRs) of PC patients, over a 2 year follow-up, as compared to UPC.
The primary hypothesis is that there will be a significant increase in the number of patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2 years after clinics are randomized to the PROUD intervention compared to PC clinics randomized to UPC. This implementation objective reflects whether the PROUD intervention increases initiation of and/or retention in OUD treatment, documented in EHRs within medical settings.
The main secondary objective is to test the hypothesis that PC patients with OUDs documented in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention clinics, compared to those who receive care in UPC clinics, will have fewer days of acute care utilization (including urgent care, emergency department [ED] and hospital care) in the 2 years after randomization. This effectiveness objective assesses whether implementation of the MA Model improves patient outcomes.
- Conditions
- Opioid-use Disorder
- Being tested
- PROUD Intervention
- Keywords
- Opioid Use Disorder, Primary Care, Buprenorphine, Naltrexone
- 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.
PROUD InterventionOther
The PROUD intervention includes 3 strategies used to implement the MA Model: 1. Clinic leadership receives funding for a 1.0 full time equivalent NCM for 2 years after randomization and technical support for recruiting and hiring the NCM. Once hired for the study, the NCM will receive technical assistance (TA) from experts at Boston Medical Center (BMC) supported by PROUD, but NCMs will be employed and supervised by the health system. 2. Experts at BMC who originally developed and disseminated the MA Model will: provide intervention clinics with a Manual; train PROUD NCMs at BMC; and provide the ongoing TA for 2 years after randomization. 3. At least 3 primary care providers in the PROUD intervention clinic will obtain DEA waivers to prescribe buprenorphine for OUDs, if not already waivered, and work closely with the NCM to offer high quality primary care for OUDs (e.g. medication treatment with buprenorphine or naltrexone with close follow-up to maximize retention in treatment).
| Study group | Role | What they receive |
|---|---|---|
| PROUD Intervention | Active comparator | Primary care clinics randomized to the PROUD Intervention will implement the Massachusetts (MA) Model of collaborative care for opioids use disorders (OUDs). The PROUD trial provides financial support to cover the nurse case manager (NCM) salary and technical assistance for the duration of the study, but the health systems-not investigators-implement the MA Model as part of quality improvement, and the health system and its clinicians provide all clinical care. Receives: Other: PROUD Intervention |
| Usual Primary Care | No intervention | Clinics randomized to usual primary care do not receive any resources or support from the study but are free to improve opioid use disorder (OUD) care in any way they choose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-days of OUD Medication Treatment
Clinic-level number of patient-days of OUD treatment with buprenorphine and injectable naltrexone documented in the EHR during the period from randomization until two years after, reported per 10,000 primary care (PC) patients in the clinic in the 2 years post-randomization (reported as patient-years of treatment per 10,000).
Measured: 2-year period post-randomization
Secondary outcomes (1)
Acute Care Utilization
Patient-level number of days of acute care utilization during the period from randomization until two years after, among patients with an OUD diagnosis documented in the EHR in the three years prior to randomization.
Measured: 2-year period post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start28 Feb 2018
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Parallel groups
- Model description
- Pragmatic Trial: Six health systems are participating in a pragmatic, cluster-randomized, quality improvement trial (hybrid Type III implementation trial). Each of the 6 health systems provided 2 PC clinics willing to be in the randomized controlled trial. Each health system will implement collaborative care for OUD treatment in one randomly selected PC clinic. All data used to evaluate primary and secondary outcomes are secondary data from the EHR or insurance claims.
- Masking
- None (open label)
- Enrolment
- 377,373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Katharine A Bradley, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407638
- Sponsor's protocol ID
- CTN-0074
- Other IDs
- UG1DA040314
- Acronym
- PROUD
- Status last verified
- May 2026
- First submitted
- 16 Jan 2018
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The NIDA Data Share website will include a description of the PROUD trial's main analytic dataset supporting the primary objective and information on how to obtain the dataset, which must remain de-identified. Investigators wishing to obtain PROUD study data should contact the Lead Investigator to discuss the dataset request. Requests will be reviewed on a case-by-case basis and may require funding to support 1) programming to create the necessary de-identified analytic dataset(s) and 2) establish a data transfer agreement and IRB approval. The NIDA Data Share website will explicitly indicate that data elements for site or clinic may be obtained, but access will be highly restricted and will need the appropriate agreements and approvals in place. If data on sites and clinics are provided, names will be masked. De-identification includes masking all dates and zip codes prior to providing the data.
Publications
Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.
PubMed 21403039LaBelle CT, Han SC, Bergeron A, Samet JH. Office-Based Opioid Treatment with Buprenorphine (OBOT-B): Statewide Implementation of the Massachusetts Collaborative Care Model in Community Health Centers. J Subst Abuse Treat. 2016 Jan;60:6-13. doi: 10.1016/j.jsat.2015.06.010. Epub 2015 Jun 26.
PubMed 26233698Wartko PD, Bobb JF, Boudreau DM, Matthews AG, McCormack J, Lee AK, Qiu H, Yu O, Hyun N, Idu AE, Campbell CI, Saxon AJ, Liu DS, Altschuler A, Samet JH, Labelle CT, Zare-Mehrjerdi M, Stotts AL, Braciszewski JM, Murphy MT, Dryden D, Arnsten JH, Cunningham CO, Horigian VE, Szapocznik J, Glass JE, Caldeiro RM, Phillips RC, Shea M, Bart G, Schwartz RP, McNeely J, Liebschutz JM, Tsui JI, Merrill JO, Lapham GT, Addis M, Bradley KA; PROUD Trial Collaborators. Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Dec 1;183(12):1343-1354. doi: 10.1001/jamainternmed.2023.5701.
PubMed 37902748Bobb JF, Idu AE, Qiu H, Yu O, Boudreau DM, Wartko PD, Matthews AG, McCormack J, Lee AK, Campbell CI, Saxon AJ, Liu DS, Altschuler A, Samet JH, Northrup TF, Braciszewski JM, Murphy MT, Arnsten JH, Cunningham CO, Horigian VE, Szapocznik J, Glass JE, Caldeiro RM, Tsui JI, Burganowski RP, Weinstein ZM, Murphy SM, Hyun N, Bradley KA. Offering nurse care management for opioid use disorder in primary care: Impact on emergency and hospital utilization in a cluster-randomized implementation trial. Drug Alcohol Depend. 2024 Aug 1;261:111350. doi: 10.1016/j.drugalcdep.2024.111350. Epub 2024 Jun 10.
PubMed 38875880Lapham GT, Hyun N, Bobb JF, Wartko PD, Matthews AG, Yu O, McCormack J, Lee AK, Liu DS, Samet JH, Zare-Mehrjerdi M, Braciszewski JM, Murphy MT, Arnsten JH, Horigian V, Caldeiro RM, Addis M, Bradley KA. Nurse Care Management of Opioid Use Disorder Treatment After 3 Years: A Secondary Analysis of the PROUD Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2447447. doi: 10.1001/jamanetworkopen.2024.47447.
PubMed 39576637Campbell CI, Saxon AJ, Boudreau DM, Wartko PD, Bobb JF, Lee AK, Matthews AG, McCormack J, Liu DS, Addis M, Altschuler A, Samet JH, LaBelle CT, Arnsten J, Caldeiro RM, Borst DT, Stotts AL, Braciszewski JM, Szapocznik J, Bart G, Schwartz RP, McNeely J, Liebschutz JM, Tsui JI, Merrill JO, Glass JE, Lapham GT, Murphy SM, Weinstein ZM, Yarborough BJH, Bradley KA. PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. Addict Sci Clin Pract. 2021 Jan 31;16(1):9. doi: 10.1186/s13722-021-00218-w.
PubMed 33517894Bobb JF, Qiu H, Matthews AG, McCormack J, Bradley KA. Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study. Trials. 2020 Mar 23;21(1):289. doi: 10.1186/s13063-020-4148-z.
PubMed 32293514
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
- ClinicalTrials.gov ID
- NCT03407638
- Acronym / sponsor ID
- PROUD / CTN-0074
- Conditions
- Opioid-use Disorder
- Keywords
- Opioid Use Disorder, Primary Care, Buprenorphine, Naltrexone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377,373 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 11 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, despite the current opioid epidemic and expert recommendations that OUDs should be treated in PC, most PC clinics do not offer treatment for OUDs. This reflects a lack of consensus among health system leaders and clinicians that OUDs should be treated in PC.
The PRimary care Opioid Use Disorders treatment (PROUD) Trial is a pragmatic cluster-randomized, quality improvement trial that evaluates implementation of a team-based approach to PC supported by a full time nurse (the "PROUD intervention"). This type of team-based PC is often referred to as "collaborative care" for management of OUDs in PC, and this type of trial is often referred to as a Hybrid Type III implementation trial.
The trial is being conducted in 6 diverse health systems spanning 5 states (New York, Florida, Michigan, Texas, and Washington), with 2 PC clinics in each system randomized. One clinic is randomly selected to implement the PROUD intervention and the other continues usual PC (UPC).
The overall objective of the PROUD trial is to provide information to guide health system leaders who are faced with the decision of whether or not to treat OUDs in PC, by evaluating the benefits of implementing the PROUD intervention that integrates high quality OUD treatment (i.e. buprenorphine or injectable naltrexone) into the normal flow of PC.
The primary objective of the PROUD trial is to evaluate whether the PROUD intervention increases OUD treatment with buprenorphine or injectable naltrexone, documented in the electronic health records (EHRs) of PC patients, over a 2 year follow-up, as compared to UPC.
The primary hypothesis is that there will be a significant increase in the number of patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2 years after clinics are randomized to the PROUD intervention compared to PC clinics randomized to UPC. This implementation objective reflects whether the PROUD intervention increases initiation of and/or retention in OUD treatment, documented in EHRs within medical settings.
The main secondary objective is to test the hypothesis that PC patients with OUDs documented in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention clinics, compared to those who receive care in UPC clinics, will have fewer days of acute care utilization (including urgent care, emergency department [ED] and hospital care) in the 2 years after randomization. This effectiveness objective assesses whether implementation of the MA Model improves patient outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic Trial: Six health systems are participating in a pragmatic, cluster-randomized, quality improvement trial (hybrid Type III implementation trial). Each of the 6 health systems provided 2 PC clinics willing to be in the randomized controlled trial. Each health system will implement collaborative care for OUD treatment in one randomly selected PC clinic. All data used to evaluate primary and secondary outcomes are secondary data from the EHR or insurance claims.
| Arm | Type | Receives |
|---|---|---|
| PROUD Intervention | Active comparator | Other: PROUD InterventionPrimary care clinics randomized to the PROUD Intervention will implement the Massachusetts (MA) Model of collaborative care for opioids use disorders (OUDs). The PROUD trial provides financial support to cover the nurse case manager (NCM) salary and technical assistance for the duration of the study, but the health systems-not investigators-implement the MA Model as part of quality improvement, and the health system and its clinicians provide all clinical care. |
| Usual Primary Care | No intervention | –Clinics randomized to usual primary care do not receive any resources or support from the study but are free to improve opioid use disorder (OUD) care in any way they choose. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients who have requested through their health systems to opt out of research will be excluded from this study.
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 |
|---|---|---|
| PROUD InterventionThe PROUD intervention includes 3 strategies used to implement the MA Model: 1. Clinic leadership receives funding for a 1.0 full time equivalent NCM for 2 years after randomization and technical support for recruiting and hiring the NCM. Once hired for the study, the NCM will receive technical assistance (TA) from experts at Boston Medical Center (BMC) supported by PROUD, but NCMs will be employed and supervised by the health system. 2. Experts at BMC who originally developed and disseminated the MA Model will: provide intervention clinics with a Manual; train PROUD NCMs at BMC; and provide the ongoing TA for 2 years after randomization. 3. At least 3 primary care providers in the PROUD intervention clinic will obtain DEA waivers to prescribe buprenorphine for OUDs, if not already waivered, and work closely with the NCM to offer high quality primary care for OUDs (e.g. medication treatment with buprenorphine or naltrexone with close follow-up to maximize retention in treatment). | Other | PROUD Intervention |
Primary outcome
Patient-days of OUD Medication Treatment
Time frame: 2-year period post-randomization
Clinic-level number of patient-days of OUD treatment with buprenorphine and injectable naltrexone documented in the EHR during the period from randomization until two years after, reported per 10,000 primary care (PC) patients in the clinic in the 2 years post-randomization (reported as patient-years of treatment per 10,000).
1 secondary outcome
Acute Care Utilization
Time frame: 2-year period post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21403039Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.
- Background: PubMed 26233698LaBelle CT, Han SC, Bergeron A, Samet JH. Office-Based Opioid Treatment with Buprenorphine (OBOT-B): Statewide Implementation of the Massachusetts Collaborative Care Model in Community Health Centers. J Subst Abuse Treat. 2016 Jan;60:6-13. doi: 10.1016/j.jsat.2015.06.010. Epub 2015 Jun 26.
- Results publication: PubMed 37902748Wartko PD, Bobb JF, Boudreau DM, Matthews AG, McCormack J, Lee AK, Qiu H, Yu O, Hyun N, Idu AE, Campbell CI, Saxon AJ, Liu DS, Altschuler A, Samet JH, Labelle CT, Zare-Mehrjerdi M, Stotts AL, Braciszewski JM, Murphy MT, Dryden D, Arnsten JH, Cunningham CO, Horigian VE, Szapocznik J, Glass JE, Caldeiro RM, Phillips RC, Shea M, Bart G, Schwartz RP, McNeely J, Liebschutz JM, Tsui JI, Merrill JO, Lapham GT, Addis M, Bradley KA; PROUD Trial Collaborators. Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Dec 1;183(12):1343-1354. doi: 10.1001/jamainternmed.2023.5701.
- Results publication: PubMed 38875880Bobb JF, Idu AE, Qiu H, Yu O, Boudreau DM, Wartko PD, Matthews AG, McCormack J, Lee AK, Campbell CI, Saxon AJ, Liu DS, Altschuler A, Samet JH, Northrup TF, Braciszewski JM, Murphy MT, Arnsten JH, Cunningham CO, Horigian VE, Szapocznik J, Glass JE, Caldeiro RM, Tsui JI, Burganowski RP, Weinstein ZM, Murphy SM, Hyun N, Bradley KA. Offering nurse care management for opioid use disorder in primary care: Impact on emergency and hospital utilization in a cluster-randomized implementation trial. Drug Alcohol Depend. 2024 Aug 1;261:111350. doi: 10.1016/j.drugalcdep.2024.111350. Epub 2024 Jun 10.
- Derived from this study: PubMed 39576637Lapham GT, Hyun N, Bobb JF, Wartko PD, Matthews AG, Yu O, McCormack J, Lee AK, Liu DS, Samet JH, Zare-Mehrjerdi M, Braciszewski JM, Murphy MT, Arnsten JH, Horigian V, Caldeiro RM, Addis M, Bradley KA. Nurse Care Management of Opioid Use Disorder Treatment After 3 Years: A Secondary Analysis of the PROUD Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2447447. doi: 10.1001/jamanetworkopen.2024.47447.
- Derived from this study: PubMed 33517894Campbell CI, Saxon AJ, Boudreau DM, Wartko PD, Bobb JF, Lee AK, Matthews AG, McCormack J, Liu DS, Addis M, Altschuler A, Samet JH, LaBelle CT, Arnsten J, Caldeiro RM, Borst DT, Stotts AL, Braciszewski JM, Szapocznik J, Bart G, Schwartz RP, McNeely J, Liebschutz JM, Tsui JI, Merrill JO, Glass JE, Lapham GT, Murphy SM, Weinstein ZM, Yarborough BJH, Bradley KA. PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. Addict Sci Clin Pract. 2021 Jan 31;16(1):9. doi: 10.1186/s13722-021-00218-w.
- Derived from this study: PubMed 32293514Bobb JF, Qiu H, Matthews AG, McCormack J, Bradley KA. Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study. Trials. 2020 Mar 23;21(1):289. doi: 10.1186/s13063-020-4148-z.
- Individual participant dataSharing planned: Yes. The NIDA Data Share website will include a description of the PROUD trial's main analytic dataset supporting the primary objective and information on how to obtain the dataset, which must remain de-identified. Investigators wishing to obtain PROUD study data should contact the Lead Investigator to discuss the dataset request. Requests will be reviewed on a case-by-case basis and may require funding to support 1) programming to create the necessary de-identified analytic dataset(s) and 2) establish a data transfer agreement and IRB approval. The NIDA Data Share website will explicitly indicate that data elements for site or clinic may be obtained, but access will be highly restricted and will need the appropriate agreements and approvals in place. If data on sites and clinics are provided, names will be masked. De-identification includes masking all dates and zip codes prior to providing the data.
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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.
Katharine A Bradley, MD, MPH principal investigator
Kaiser Permanente
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROUD Intervention in people with Opioid-use Disorder, run by Kaiser Permanente at 6 sites in United States.
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 4 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 11 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient-days of OUD Medication Treatment (time frame: 2-year period post-randomization). 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 NCT03407638, which also lists 7 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 11 Jun 2026.