Opioid-use DisorderCHAMPNCT04600414
Collaborating to Heal Addiction and Mental Health in Primary Care
A study testing Collaborative Care for Mental Health Symptoms and Collaborative Care for Opioid Use Disorder and Mental Health Symptoms in people with Opioid-use Disorder and Mental Health Disorder, run by University of Washington at 33 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Mental Health Disorder
- What is being tested?
- Collaborative Care for Mental Health Symptoms and Collaborative Care for Opioid Use Disorder and Mental Health Symptoms
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 33 sitesUnited States
- Study dates
- 16 Nov 2020to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Emory University Hospital Midtown-Radiology
Atlanta, Georgia, 30308
Emory Clinic at Saint Joseph's - Primary Care
Atlanta, Georgia, 30342
Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates
Beverly, Massachusetts, 01915
Minooka Healthcare Center - Ridge Road Campus
Channahon, Illinois, 60410
Beth Israel Deaconess HealthCare-Chelsea
Chelsea, Massachusetts, 02150
Oak Street Health Madison St.
Chicago, Illinois, 60624
Oak Street Health Hermosa
Chicago, Illinois, 60639
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
Oak Street Health Pleasant Grove Primary Care Clinic
Dallas, Texas, 75217
Emory at Dunwoody - Family Medicine
Dunwoody, Georgia, 30338
Oak Street Health Meadowbrook Primary Care Clinic
Fort Worth, Texas, 76103
Oak Street Health North Side Primary Care
Fort Worth, Texas, 76164
Gardner Healthcare Center of Morris Hospital
Gardner, Illinois, 60424
Oak Street Health Gary Primary Care Clinic
Gary, Indiana, 46408
Minooka Healthcare Center of Morris Hospital - Mondamin St.
Minooka, Illinois, 60447
UW Health Yahara Clinic
Monona, Wisconsin, 53716
Morris Healthcare Center of Morris Hospital - Dresden Drive
Morris, Illinois, 60450
Oak Street Health Chicago Ave Primary Care Clinic
Oak Park, Illinois, 60302
OneWorld Community Health Centers Livestock Exchange
Omaha, Nebraska, 68107
OneWorld Community Health Centers Northwest
Omaha, Nebraska, 68134
Berkshire Hillcrest Family Health Center
Pittsfield, Massachusetts, 01201
Kootenai Clinic Family Medicine Post Falls
Post Falls, Idaho, 83854
Northshore Medical Group Stevenson
Stevenson, Washington, 98648
Emory at Rockbridge - Primary Care & Nephrology
Stone Mountain, Georgia, 30087
PeaceHealth Family Medicine of Southwest Washington
Vancouver, Washington, 98663
Peace Health Fisher's Landing
Vancouver, Washington, 98683
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
Northshore Medical Group White Salmon
White Salmon, Washington, 98672
Berkshire Williamstown Medical
Williamstown, Massachusetts, 01267
UW Health Deforest-Windsor Clinic
Windsor, Wisconsin, 53598
About this study
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.
Read the detailed description
This multi-site study involves a sequence of trials (Pre-Post -> Effectiveness -> Implementation 3) to examine our primary, secondary and exploratory objectives.
- Pre-Post trial (secondary objective) - Screening for Opioid User Disorder (OUD) will be integrated into Mental Health Disorder (MHD) screening and electronic health record (EHR) data will be used to determine if screening improves the detection of new cases of OUD during the first six months of the trial compared to the six months prior.
- Cluster randomized Effectiveness trial (primary objective) - The primary objective of the trial is to test the effectiveness of delivering (Medication for OUD) MOUD in the context of Collaborative Care Management (CoCM) for MHD, hereafter termed the "intervention" compared to CoCM for MHD only hereafter termed the "control". All 24 sites have previously partnered with the AIMS Center to implement CoCM for MHD. After monitoring CoCM for MHD fidelity during a three month "run in" phase, the investigators will categorize clinics into one of two cohorts and then randomize them.
- Cohort 1 (n=600) - Randomize clinics with high CoCM for MHD fidelity to sequentially adding MOUD for OUD (intervention group) or maintenance CoCM for MHD only (control group).
- Cohort 2 (n=600) - Randomize clinics with low CoCM for MHD fidelity to simultaneous implementation of CoCM for MHD and OUD (intervention group ) or CoCM for MHD only (control group).
- Cluster randomized Implementation trial (exploratory objective) - At the end of the Effectiveness trial, the intervention clinics will be randomized to receive a low-intensity or high-intensity implementation strategy to promote sustainability
- Conditions
- Opioid-use Disorder, Mental Health Disorder
- Being tested
- Collaborative Care for Mental Health Symptoms, Collaborative Care for Opioid Use Disorder and Mental Health Symptoms
- Keywords
- Primary Care, Collaborative Care
- Medical subject headings
- Opioid-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care for Mental Health SymptomsOther
CoCM is based on six key principles: 1) evidence-based, 2) measurement-based, 3) team-based, 4) population-based, 5) patient-centered, and 6) accountable. CoCM supports the delivery of evidence-based pharmacological and psychosocial treatments. CoCM is measurement-based with screening and monitoring of patient-reported outcomes over time to assess treatment response and facilitate treatment adjustments. CoCM is team-based led by a primary care provider with support from a care manager in consultation with a psychiatrist who provides treatment recommendations for patients who are not responding. CoCM is population-based whereby a registry is used to monitor treatment engagement and facilitate the identification of patients falling through the cracks. CoCM is patient-centered with proactive outreach to engage and activate patients. Collaborative care is accountable with continuous quality improvement to meet clinic performance benchmarks.
Collaborative Care for Opioid Use Disorder and Mental Health SymptomsOther
Pharmacologic treatment of OUD will rely mainly on transmucosal buprenorphine/naloxone prescribed by primary care providers with DATA 2000 waivers. Measurement-based care and "treat to target" are fundamental principles of CoCM and will be incorporated into the intervention. Care managers will ask four yes/no questions about: 1) opioid withdrawal symptoms, 2) illicit opioid craving, 3) illicit opioid use, 4) medication side effects. If necessary, consulting psychiatrists will then recommend a change to the treatment plan to the primary care provider. In the case of buprenorphine/naloxone, options for changing the treatment plan include: 1) increasing the dosage (max dose 32mg), 2) augmenting with clonidine, 3) switching to injectable buprenorphine, and/or 4) intensifying psychosocial interventions. If the patient is experiencing medication side effects, but not opioid withdrawal symptoms or illicit opioid craving, consideration will be given to lowering the medication dosage.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care for Mental Health Symptoms | Active comparator | Collaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for mental health disorders. Receives: Other: Collaborative Care for Mental Health Symptoms |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Experimental | Collaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for opioid use disorder. Receives: Other: Collaborative Care for Mental Health Symptoms; Other: Collaborative Care for Opioid Use Disorder and Mental Health Symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use Other Than As Prescribed
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."
Measured: 6 months
Mental Health Functioning
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)
Measured: 6 Months
Secondary outcomes (4)
Depression Symptoms
Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse)
Measured: 6 months
Anxiety Symptoms
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)
Measured: 6 months
PTSD Symptoms
PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse)
Measured: 6 months
Medications for Opioid Use Disorder (MOUD) Persistence
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.
Measured: 90 days prior to the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start16 Nov 2020
- Primary completion15 Feb 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Trial. Clinics within healthcare systems are paired and randomized to intervention or control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Cooper Fortney, University of Washington
- Investigators
- John Fortney, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600414
- Sponsor's protocol ID
- SITE00000376
- Other IDs
- UF1MH121942
- Acronym
- CHAMP
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2020
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PIs will follow the NIH Healthcare Systems Research Collaboratory recommendations for data sharing. Data from this project will be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data. Data will be shared via the National Database for Clinical Trials (NDCT) related to Mental Illness. Investigators will certify the quality of all data generated by grants funded under this FOA prior to submission to NDCT and review their data for accuracy after submission. Precautions will be made regarding patient confidentiality, including HIPAA-compliant patient de-identification for all patients. Public-use datasets will not include patient identifiers, or health system identifiers, characteristics or prescribing/referral practices of individual providers.
Publications
Fortney JC, Ratzliff AD, Blanchard BE, Ferro L, Chase E, Rouvere J, Duncan MH, Merrill JO, Simpson T, Williams EC, Austin EJ, Curran GM, Schoenbaum M, Heagerty PJ, Saxon AJ. Collaborative Care for Opioid Use Disorder in Primary Care: A Hybrid Type 2 Cluster Randomized Clinical Trial. JAMA Psychiatry. 2025 Oct 1;82(10):956-966. doi: 10.1001/jamapsychiatry.2025.2126.
PubMed 40833733Fortney JC, Ratzliff AD, Blanchard BE, Ferro L, Rouvere J, Chase E, Duncan MH, Merrill JO, Simpson T, Williams EC, Austin EJ, Curran GM, Schoenbaum M, Heagerty PJ, Saxon AJ. Collaborating to heal addiction and mental health in primary care (CHAMP): A protocol for a hybrid type 2a trial. Contemp Clin Trials. 2024 Nov;146:107700. doi: 10.1016/j.cct.2024.107700. Epub 2024 Sep 23.
PubMed 39322115
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborating to Heal Addiction and Mental Health in Primary Care
- ClinicalTrials.gov ID
- NCT04600414
- Acronym / sponsor ID
- CHAMP / SITE00000376
- Conditions
- Opioid-use Disorder, Mental Health Disorder
- Keywords
- Primary Care, Collaborative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Arkansas, Kaiser Permanente
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Posted 3 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multi-site study involves a sequence of trials (Pre-Post -> Effectiveness -> Implementation 3) to examine our primary, secondary and exploratory objectives.
- Pre-Post trial (secondary objective) - Screening for Opioid User Disorder (OUD) will be integrated into Mental Health Disorder (MHD) screening and electronic health record (EHR) data will be used to determine if screening improves the detection of new cases of OUD during the first six months of the trial compared to the six months prior.
- Cluster randomized Effectiveness trial (primary objective) - The primary objective of the trial is to test the effectiveness of delivering (Medication for OUD) MOUD in the context of Collaborative Care Management (CoCM) for MHD, hereafter termed the "intervention" compared to CoCM for MHD only hereafter termed the "control". All 24 sites have previously partnered with the AIMS Center to implement CoCM for MHD. After monitoring CoCM for MHD fidelity during a three month "run in" phase, the investigators will categorize clinics into one of two cohorts and then randomize them.
- Cohort 1 (n=600) - Randomize clinics with high CoCM for MHD fidelity to sequentially adding MOUD for OUD (intervention group) or maintenance CoCM for MHD only (control group).
- Cohort 2 (n=600) - Randomize clinics with low CoCM for MHD fidelity to simultaneous implementation of CoCM for MHD and OUD (intervention group ) or CoCM for MHD only (control group).
- Cluster randomized Implementation trial (exploratory objective) - At the end of the Effectiveness trial, the intervention clinics will be randomized to receive a low-intensity or high-intensity implementation strategy to promote sustainability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Trial. Clinics within healthcare systems are paired and randomized to intervention or control.
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care for Mental Health Symptoms | Active comparator | Other: Collaborative Care for Mental Health SymptomsCollaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for mental health disorders. |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Experimental | Other: Collaborative Care for Mental Health Symptoms, Other: Collaborative Care for Opioid Use Disorder and Mental Health SymptomsCollaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for opioid use disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Care for Mental Health SymptomsCoCM is based on six key principles: 1) evidence-based, 2) measurement-based, 3) team-based, 4) population-based, 5) patient-centered, and 6) accountable. CoCM supports the delivery of evidence-based pharmacological and psychosocial treatments. CoCM is measurement-based with screening and monitoring of patient-reported outcomes over time to assess treatment response and facilitate treatment adjustments. CoCM is team-based led by a primary care provider with support from a care manager in consultation with a psychiatrist who provides treatment recommendations for patients who are not responding. CoCM is population-based whereby a registry is used to monitor treatment engagement and facilitate the identification of patients falling through the cracks. CoCM is patient-centered with proactive outreach to engage and activate patients. Collaborative care is accountable with continuous quality improvement to meet clinic performance benchmarks. | Other | Collaborative Care for Mental Health Symptoms, Collaborative Care for Opioid Use Disorder and Mental Health Symptoms |
| Collaborative Care for Opioid Use Disorder and Mental Health SymptomsPharmacologic treatment of OUD will rely mainly on transmucosal buprenorphine/naloxone prescribed by primary care providers with DATA 2000 waivers. Measurement-based care and "treat to target" are fundamental principles of CoCM and will be incorporated into the intervention. Care managers will ask four yes/no questions about: 1) opioid withdrawal symptoms, 2) illicit opioid craving, 3) illicit opioid use, 4) medication side effects. If necessary, consulting psychiatrists will then recommend a change to the treatment plan to the primary care provider. In the case of buprenorphine/naloxone, options for changing the treatment plan include: 1) increasing the dosage (max dose 32mg), 2) augmenting with clonidine, 3) switching to injectable buprenorphine, and/or 4) intensifying psychosocial interventions. If the patient is experiencing medication side effects, but not opioid withdrawal symptoms or illicit opioid craving, consideration will be given to lowering the medication dosage. | Other | Collaborative Care for Opioid Use Disorder and Mental Health Symptoms |
Primary outcome
Opioid Use Other Than As Prescribed
Time frame: 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."
Mental Health Functioning
Time frame: 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)
4 secondary outcomes
Depression Symptoms
Time frame: 6 months
Anxiety Symptoms
Time frame: 6 months
PTSD Symptoms
Time frame: 6 months
Medications for Opioid Use Disorder (MOUD) Persistence
Time frame: 90 days prior to the 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40833733Fortney JC, Ratzliff AD, Blanchard BE, Ferro L, Chase E, Rouvere J, Duncan MH, Merrill JO, Simpson T, Williams EC, Austin EJ, Curran GM, Schoenbaum M, Heagerty PJ, Saxon AJ. Collaborative Care for Opioid Use Disorder in Primary Care: A Hybrid Type 2 Cluster Randomized Clinical Trial. JAMA Psychiatry. 2025 Oct 1;82(10):956-966. doi: 10.1001/jamapsychiatry.2025.2126.
- Derived from this study: PubMed 39322115Fortney JC, Ratzliff AD, Blanchard BE, Ferro L, Rouvere J, Chase E, Duncan MH, Merrill JO, Simpson T, Williams EC, Austin EJ, Curran GM, Schoenbaum M, Heagerty PJ, Saxon AJ. Collaborating to heal addiction and mental health in primary care (CHAMP): A protocol for a hybrid type 2a trial. Contemp Clin Trials. 2024 Nov;146:107700. doi: 10.1016/j.cct.2024.107700. Epub 2024 Sep 23.
- Individual participant dataSharing planned: Yes. The PIs will follow the NIH Healthcare Systems Research Collaboratory recommendations for data sharing. Data from this project will be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data. Data will be shared via the National Database for Clinical Trials (NDCT) related to Mental Illness. Investigators will certify the quality of all data generated by grants funded under this FOA prior to submission to NDCT and review their data for accuracy after submission. Precautions will be made regarding patient confidentiality, including HIPAA-compliant patient de-identification for all patients. Public-use datasets will not include patient identifiers, or health system identifiers, characteristics or prescribing/referral practices of individual providers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Fortney, PhD principal investigator
University of Washington
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care for Mental Health Symptoms and Collaborative Care for Opioid Use Disorder and Mental Health Symptoms in people with Opioid-use Disorder and Mental Health Disorder, run by University of Washington at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use Other Than As Prescribed (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600414, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.