N/A
N=254
Collaborating to Heal Addiction and Mental Health in Primary Care
Opioid-use Disorder · Mental Health Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04600414 ↗Enrolled (actual)
254
Serious AEs
12.9%
Results posted
Oct 2025
Primary outcome: Primary: Opioid Use Other Than As Prescribed — 3.92; 0.72 Days — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Collaborative Care for Mental Health Symptoms (Other); Collaborative Care for Opioid Use Disorder and Mental Health Symptoms (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Use Other Than As Prescribed |
3.92; 0.72 | <0.001 sig |
| PRIMARY Mental Health Functioning |
38.90; 39.09 | 0.532 |
| SECONDARY Depression Symptoms |
1.30; 1.24 | — |
| SECONDARY Anxiety Symptoms |
55.61; 55.82 | — |
| SECONDARY PTSD Symptoms |
28.29; 27.32 | — |
| SECONDARY Medications for Opioid Use Disorder (MOUD) Persistence |
0.74; 0.90 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Screen positive on the NIDA-ASSIST OUD items or referred to the trial by one of the clinic's providers AND
- Meet clinical criteria for ≥2 symptoms of OUD on the DSM-5 checklist (administered by a clinician) AND
- Screen positive for depression on the PHQ-9 (≥ 5) OR generalized anxiety on the GAD-7 (≥ 5) OR PTSD on the PC-PTSD-5 (≥ 1) within past 6 months.
Exclusion Criteria
- Patient is being prescribed psychotropic medication (including MOUD) by a Mental Health Care Specialist (typically practicing in a specialty addiction treatment setting).
- Patient is receiving or prefers to seek OUD treatment in specialty care setting including opioid treatment programs
- Patient does not speak English or Spanish
- Patient is younger than 18 years of age
- Patient has a diagnosis of dementia
- Patient lacks the capacity to provide informed consent
- Patient doesn't plan on getting care at the clinic for the next 6 months.
Data sourced from ClinicalTrials.gov (NCT04600414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.