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Can one doctor visit tackle both addiction and depression?

NCT ID NCT04600414

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a team-based care model can help people with both opioid use disorder and mental health issues like depression or anxiety. 254 adults in primary care received either full collaborative care for both conditions or just mental health support. The goal was to see if treating both together reduces illicit opioid use and improves mental health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Collaborative Care model (team-based care with a care manager and psychiatrist)
What this could lead to
If successful, this could show that combining mental health and opioid addiction treatment in primary care is more effective than treating mental health alone.
What could go wrong
This is a completed trial, but results may not apply to all clinics. The study relies on self-reported opioid use, which may not be fully accurate.

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

254 people

The number who actually took part.

Started

Nov 2020

Finished

Aug 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Screen positive on the NIDA-ASSIST OUD items or referred to the trial by one of the clinic's providers AND 2. Meet clinical criteria for ≥2 symptoms of OUD on the DSM-5 checklist (administered by a clinician) AND 3. 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: 1. Patient is being prescribed psychotropic medication (including MOUD) by a Mental Health Care Specialist (typically practicing in a specialty addiction treatment setting). 2. Patient is receiving or prefers to seek OUD treatment in specialty care setting including opioid treatment programs 3. Patient does not speak English or Spanish 4. Patient is younger than 18 years of age 5. Patient has a diagnosis of dementia 6. Patient lacks the capacity to provide informed consent 7. Patient doesn't plan on getting care at the clinic for the next 6 months.

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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

  • Berkshire Hillcrest Family Health Center

    Pittsfield, Massachusetts, 01201, United States

  • Berkshire Williamstown Medical

    Williamstown, Massachusetts, 01267, United States

  • Beth Israel Deaconess HealthCare-Chelsea

    Chelsea, Massachusetts, 02150, United States

  • Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates

    Beverly, Massachusetts, 01915, United States

  • Emory Clinic at Saint Joseph's - Primary Care

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital Midtown-Radiology

    Atlanta, Georgia, 30308, United States

  • Emory at Dunwoody - Family Medicine

    Dunwoody, Georgia, 30338, United States

  • Emory at Rockbridge - Primary Care & Nephrology

    Stone Mountain, Georgia, 30087, United States

  • Gardner Healthcare Center of Morris Hospital

    Gardner, Illinois, 60424, United States

  • Kootenai Clinic Family Medicine Ironwood

    Coeur d'Alene, Idaho, 83814, United States

  • Kootenai Clinic Family Medicine Post Falls

    Post Falls, Idaho, 83854, United States

  • Kootenai Clinic Family Medicine Residency

    Coeur d'Alene, Idaho, 83814, United States

  • Kootenai Clinic Internal Medicine Coeur d'Alene

    Coeur d'Alene, Idaho, 83814, United States

  • Minooka Healthcare Center - Ridge Road Campus

    Channahon, Illinois, 60410, United States

  • Minooka Healthcare Center of Morris Hospital - Mondamin St.

    Minooka, Illinois, 60447, United States

  • Morris Healthcare Center of Morris Hospital - Dresden Drive

    Morris, Illinois, 60450, United States

  • Northshore Medical Group Stevenson

    Stevenson, Washington, 98648, United States

  • Northshore Medical Group White Salmon

    White Salmon, Washington, 98672, United States

  • Oak Street Health Chicago Ave Primary Care Clinic

    Oak Park, Illinois, 60302, United States

  • Oak Street Health Gary Primary Care Clinic

    Gary, Indiana, 46408, United States

  • Oak Street Health Hermosa

    Chicago, Illinois, 60639, United States

  • Oak Street Health Madison St.

    Chicago, Illinois, 60624, United States

  • Oak Street Health Meadowbrook Primary Care Clinic

    Fort Worth, Texas, 76103, United States

  • Oak Street Health North Side Primary Care

    Fort Worth, Texas, 76164, United States

  • Oak Street Health Pleasant Grove Primary Care Clinic

    Dallas, Texas, 75217, United States

  • OneWorld Community Health Centers Livestock Exchange

    Omaha, Nebraska, 68107, United States

  • OneWorld Community Health Centers Northwest

    Omaha, Nebraska, 68134, United States

  • Peace Health Fisher's Landing

    Vancouver, Washington, 98683, United States

  • PeaceHealth Family Medicine of Southwest Washington

    Vancouver, Washington, 98663, United States

  • UW Health Deforest-Windsor Clinic

    Windsor, Wisconsin, 53598, United States

  • UW Health Yahara Clinic

    Monona, Wisconsin, 53716, United States

  • Unity Health Care Anacostia Health Center

    Washington D.C., District of Columbia, 20020, United States

  • Unity Health Care Minnesota Avenue Health Center

    Washington D.C., District of Columbia, 20019, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.