Collaborating to Heal Addiction and Mental Health in Primary Care
Public ClinicalTrials.gov record NCT04600414. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The gold-standard intervention for Opioid Use Disorder (OUD) is Medication for Opioid Use Disorder (MOUD). Because more patients with OUD need access to MOUD in primary care, the investigators are testing whether the Collaborative Care model (CoCM) is effective at treating both mental health disorders (MHD) and OUD concurrently in primary care settings. The intervention is CoCM for MHD and OUD. The active control is CoCM for MHD, but not treating OUD. The primary objective is to compare patient-reported outcomes in the intervention and control groups, and will be tested with in an Effectiveness trial. The secondary objective is to compare the detection of OUD pre- versus post-OUD screening implementation, and will be tested using a Pre-Post trial design. The exploratory objective is to compare intervention clinics randomized to a low-intensity sustainability implementation strategy or a high-intensity sustainability strategy, and will be tested in an Implementation trial.
Study identification
- NCT ID
- NCT04600414
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 254 participants
Conditions and interventions
Conditions
Interventions
- Collaborative Care for Mental Health Symptoms Other
- Collaborative Care for Opioid Use Disorder and Mental Health Symptoms Other
Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2020
- Primary completion
- Feb 14, 2024
- Completion
- Aug 30, 2024
- Last update posted
- Oct 2, 2025
2020 – 2024
United States locations
- U.S. sites
- 33
- U.S. states
- 10
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Unity Health Care Minnesota Avenue Health Center | Washington D.C. | District of Columbia | 20019 | — |
| Unity Health Care Anacostia Health Center | Washington D.C. | District of Columbia | 20020 | — |
| Emory University Hospital Midtown-Radiology | Atlanta | Georgia | 30308 | — |
| Emory Clinic at Saint Joseph's - Primary Care | Atlanta | Georgia | 30342 | — |
| Emory at Dunwoody - Family Medicine | Dunwoody | Georgia | 30338 | — |
| Emory at Rockbridge - Primary Care & Nephrology | Stone Mountain | Georgia | 30087 | — |
| Kootenai Clinic Family Medicine Ironwood | Coeur d'Alene | Idaho | 83814 | — |
| Kootenai Clinic Family Medicine Residency | Coeur d'Alene | Idaho | 83814 | — |
| Kootenai Clinic Internal Medicine Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | — |
| Kootenai Clinic Family Medicine Post Falls | Post Falls | Idaho | 83854 | — |
| Minooka Healthcare Center - Ridge Road Campus | Channahon | Illinois | 60410 | — |
| Oak Street Health Madison St. | Chicago | Illinois | 60624 | — |
| Oak Street Health Hermosa | Chicago | Illinois | 60639 | — |
| Gardner Healthcare Center of Morris Hospital | Gardner | Illinois | 60424 | — |
| Minooka Healthcare Center of Morris Hospital - Mondamin St. | Minooka | Illinois | 60447 | — |
| Morris Healthcare Center of Morris Hospital - Dresden Drive | Morris | Illinois | 60450 | — |
| Oak Street Health Chicago Ave Primary Care Clinic | Oak Park | Illinois | 60302 | — |
| Oak Street Health Gary Primary Care Clinic | Gary | Indiana | 46408 | — |
| Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates | Beverly | Massachusetts | 01915 | — |
| Beth Israel Deaconess HealthCare-Chelsea | Chelsea | Massachusetts | 02150 | — |
| Berkshire Hillcrest Family Health Center | Pittsfield | Massachusetts | 01201 | — |
| Berkshire Williamstown Medical | Williamstown | Massachusetts | 01267 | — |
| OneWorld Community Health Centers Livestock Exchange | Omaha | Nebraska | 68107 | — |
| OneWorld Community Health Centers Northwest | Omaha | Nebraska | 68134 | — |
| Oak Street Health Pleasant Grove Primary Care Clinic | Dallas | Texas | 75217 | — |
| Oak Street Health Meadowbrook Primary Care Clinic | Fort Worth | Texas | 76103 | — |
| Oak Street Health North Side Primary Care | Fort Worth | Texas | 76164 | — |
| Northshore Medical Group Stevenson | Stevenson | Washington | 98648 | — |
| PeaceHealth Family Medicine of Southwest Washington | Vancouver | Washington | 98663 | — |
| Peace Health Fisher's Landing | Vancouver | Washington | 98683 | — |
| Northshore Medical Group White Salmon | White Salmon | Washington | 98672 | — |
| UW Health Yahara Clinic | Monona | Wisconsin | 53716 | — |
| UW Health Deforest-Windsor Clinic | Windsor | Wisconsin | 53598 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04600414, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04600414 live on ClinicalTrials.gov.