NCT04600414: CHAMP

Collaborating to Heal Addiction and Mental Health in Primary Care

Completed NA Results posted Last updated 3 October 2025

What this trial tests

NA trial testing Collaborative Care for Mental Health Symptoms in Opioid-use Disorder in 254 participants. Completed in 31 August 2024.

Timeline

16 November 2020

Primary endpoint
15 February 2024

31 August 2024

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	254
Start date	16 November 2020
Primary completion	15 February 2024
Estimated completion	31 August 2024
Sites	33 locations across United States

Drugs / interventions tested

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

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →
• Mental Health Disorder — all drugs for Mental Health Disorder →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Opioid-use Disorder or Mental Health Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Use Other Than As Prescribed Primary · 6 months

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 not count times you used buprenorphine, suboxone, or methadone as directed by a healthcare provider

Group	Value	95% CI
Collaborative Care for Mental Health Symptoms	3.92	± 8.86
Collaborative Care for Opioid Use Disorder and Mental Health Symptoms	0.72	± 3.61

Mental Health Functioning Primary · 6 Months

Mental health functioning will be measured from self-report using the Mental Health Component Summary Score from the SF12V (range 0-100, higher scores are better)

Group	Value	95% CI
Collaborative Care for Mental Health Symptoms	38.90	± 13.20
Collaborative Care for Opioid Use Disorder and Mental Health Symptoms	39.09	± 14.03

Depression Symptoms Secondary · 6 months

Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse)

Group	Value	95% CI
Collaborative Care for Mental Health Symptoms	1.30	± 0.82
Collaborative Care for Opioid Use Disorder and Mental Health Symptoms	1.24	± 0.83

Anxiety Symptoms Secondary · 6 months

Anxiety symptoms will be measured from self report using the PROMIS Measure - Emotional Distress, Anxiety, Short Form 7a (range 0-100, higher scores are worse)

Group	Value	95% CI
Collaborative Care for Mental Health Symptoms	55.61	± 7.85
Collaborative Care for Opioid Use Disorder and Mental Health Symptoms	55.82	± 7.72

PTSD Symptoms Secondary · 6 months

PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse)

Group	Value	95% CI
Collaborative Care for Mental Health Symptoms	28.29	± 19.01
Collaborative Care for Opioid Use Disorder and Mental Health Symptoms	27.32	± 18.21

Medications for Opioid Use Disorder (MOUD) Persistence Secondary · 90 days prior to the 6-month follow-up

MOUD persistence will be measured from self report and specified as the proportion of days the study participant reported taking the MOUD medication during the 90 prior to the 6-month follow-up.

Group	Value	95% CI
Collaborative Care for Mental Health Symptoms	0.74	± 0.42
Collaborative Care for Opioid Use Disorder and Mental Health Symptoms	0.90	± 0.29

Perceived Access to Addiction Care for Opioid Use Disorder Secondary · 6 months

Perceived access to care will be measured from self report using the Assessment of Perceived Access to Care (APAC) instrument (range 1-5, higher scores are better)

Group	Value	95% CI
Collaborative Care for Mental Health Symptoms	3.82	± 0.86
Collaborative Care for Opioid Use Disorder and Mental Health Symptoms	4.00	± 0.74

Risk Factors for Premature Mortality Secondary · 6 months

Risk factors will include self-reported intent on self-harm, self-reported overdose, self-reported discontinuation of medications for opioid use disorder and the following adverse events reports: overdose, suicide attempt, hospitalization and ER admission.

Group	Value	95% CI
Collaborative Care for Mental Health Symptoms	0.51	± 0.50
Collaborative Care for Opioid Use Disorder and Mental Health Symptoms	0.34	± 0.47

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline - 6 month follow-up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Collaborative Care for Mental Health Symptoms

Serious: 16/132 (12%)

Deaths: 1/132

Collaborative Care for Opioid Use Disorder and Mental Health Symptoms

Serious: 14/100 (14%)

Deaths: 0/100

Serious adverse events (6 terms)

Reaction	System	Collaborative Care for Men…	Collaborative Care for Opi…
ED visit (not due to suicide attempt or NSSI- not including non-lethal overdose)	General disorders	—	—
Non-lethal overdose (that resulted in hospitalization or ED visit)	Psychiatric disorders	—	—
Hospitalization (not related to suicide or NSSI - not including non-lethal overdose)	General disorders	—	—
Suicide Attempt	Psychiatric disorders	—	—
Death	General disorders	—	—
Hospitalization (related to suicide or NSSI - not including non-lethal overdose)	Psychiatric disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Collaborative Care for Men…	Collaborative Care for Opi…
Various ailments or injuries not resulting in hospitalization or ED visit	General disorders	—	—

Most-reported serious reactions: ED visit (not due to suicide attempt or NSSI- not including non-lethal overdose), Non-lethal overdose (that resulted in hospitalization or ED visit), Hospitalization (not related to suicide or NSSI - not including non-lethal overdose), Suicide Attempt, Death, Hospitalization (related to suicide or NSSI - not including non-lethal overdose).

Data from ClinicalTrials.gov NCT04600414 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Collaborative care approaches for people with severe mental illness.
   Reilly S, Hobson-Merrett C, Gibbons B, Jones B, et al · · 2024 · cited 13× · PMID 38712709 · DOI 10.1002/14651858.cd009531.pub3
2. Collaborative Care for Opioid Use Disorder in Primary Care: A Hybrid Type 2 Cluster Randomized Clinical Trial.
   Fortney JC, Ratzliff AD, Blanchard BE, Ferro L, et al · · 2025 · cited 6× · PMID 40833733 · DOI 10.1001/jamapsychiatry.2025.2126
3. Does Screening for Opioid Use Disorder in Primary Care Increase the Percentage of Patients With a New Diagnosis?
   Fortney JC, Ratzliff AD, Blanchard BE, Johnson M, et al · · 2023 · cited 6× · PMID 37844317 · DOI 10.7326/m23-1369
4. Collaborating to heal addiction and mental health in primary care (CHAMP): A protocol for a hybrid type 2a trial.
   Fortney JC, Ratzliff AD, Blanchard BE, Ferro L, et al · · 2024 · cited 4× · PMID 39322115 · DOI 10.1016/j.cct.2024.107700