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NCT04600414 · ClinicalTrials.gov registry record · NA

Collaborating to Heal Addiction and Mental Health in Primary Care

A NA study, sponsored by University of Washington.

Completed
Registry status
NA
Development phase
254
Enrollment target

NCT04600414: Completed NA study, sponsored by University of Washington.

NCT04600414 is a NA study that has completed, run by University of Washington. The registered enrollment target is 254 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04600414, a NA study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
NA
Development phase
254 participants
Enrollment target

Study 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.

Primary Outcome

Illicit opioid use will be measured from self-report using Opioid use will be measured using item 7E from the Brief Addiction Monitor (BAM) with the following preamble: "The next question asks about your use of street opioids and use of prescription opioids that were not prescribed to you by a healthcare provider. In the past 30 days, how many days did you use opiates such as Heroin, Morphine, Dilaudid, Demerol, Oxycontin, oxy, codeine (e.g., Tylenol 2,3,4), Percocet, Vicodin, Fentanyl, etc.? Do

Interventions

  • OTHER Collaborative Care for Mental Health Symptoms
  • OTHER Collaborative Care for Opioid Use Disorder and Mental Health Symptoms

Trial Details

FieldValue
Enrollment Target 254 participants
Start Date 2020-11-16
Est. Completion 2024-08-31
Phase NA
University of Washington

1,048 total trials

What the finished NCT04600414 record still lists

NCT04600414 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Collaborative Care for Mental Health Symptoms is the first listed.

NCT04600414 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04600414 about?

NCT04600414 is a clinical study titled "Collaborating to Heal Addiction and Mental Health in Primary Care". 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 disorde...

What is the current status of trial NCT04600414?

This trial is currently completed. It is a NA study. The enrollment target is 254 participants. The study started on 2020-11-16. Estimated completion is 2024-08-31.

What interventions are being tested in trial NCT04600414?

The interventions under investigation include: Collaborative Care for Mental Health Symptoms (OTHER), Collaborative Care for Opioid Use Disorder and Mental Health Symptoms (OTHER).

Who is sponsoring clinical trial NCT04600414?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04600414's enrollment target sits among peer trials

254 407th of 2000 higher than 1,594 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04600414, the US trial registry maintained by the National Library of Medicine. NCT04600414 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.