Collaboration Leading to Addiction Treatment and Recovery From Other Stresses
CLARO
Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness
1 other identifier
interventional
729
1 country
16
Brief Summary
Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO) is a five-year project that tests whether delivering care using a collaborative model helps patients with both opioid use disorders and mental health disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedStudy Start
First participant enrolled
January 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2024
CompletedJuly 15, 2025
July 1, 2025
3.4 years
September 8, 2020
July 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Buprenorphine access
Number of days until first buprenorphine prescription after study enrollment for study participants with a new episode of OUD care (no care for at least 30 days prior). Obtained from the Prescription Drug Monitoring Program and patient survey.
Assessed at 6 months after study entry.
Buprenorphine continuity of care
The cumulative number of days the patient receives buprenorphine during the 180 days after study enrollment for study participants not on methadone at baseline. Obtained from the Prescription Drug Monitoring Program and patient survey.
Assessed at 6 months after study entry.
Major Depressive Disorder (MDD) symptom severity
Sum of items (0-27) in the PHQ-9 (Patient Health Questionnaire) at 6 months for participants with probable major depression at baseline.
Assessed at 6 months after study entry.
Post-traumatic Stress Disorder (PTSD) symptom severity
Sum of items (0-80) in PCL-5 at 6 months for study participants with probable PTSD at baseline.
Assessed at 6 months after study entry.
Secondary Outcomes (12)
Access to MDD and/or PTSD treatment
Assessed at 30 days and 180 days after study entry.
Quality of care for MDD
Assessed at 6 months after study entry.
Quality of care for PTSD
Assessed at 6 months after study entry.
MDD remission
Assessed at 6 months after study entry
MDD response
Assessed at 6 months after study entry.
- +7 more secondary outcomes
Other Outcomes (16)
Drug use frequency
Assessed over 30 days after study entry.
Stimulant use frequency
Assessed over 30 days after study entry.
Alcohol use
Assessed over 3 months after study entry.
- +13 more other outcomes
Study Arms (2)
Collaborative Care
EXPERIMENTALIntervention is administered to patients in this arm. Care to be delivered via collaborative care.
Control
NO INTERVENTIONPatients in this arm will receive enhanced usual care.
Interventions
Collaborative care consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In our model, the CC team also includes a behavioral health psychotherapist (BHP) who consults on a regular basis but does not deliver direct care.
Eligibility Criteria
You may qualify if:
- and older
- Receiving primary care at one of the participating clinical sites
- Has OUD and one or more specific co-occurring behavioral health disorders (depression and PTSD)
You may not qualify if:
- Under 18
- Does not speak English or Spanish
- Unable to consent
- Receiving both MOUD and psychotropic medication from a provider outside of the primary care health system at which the patient is enrolled
- Not receiving primary care at one of the participating clinical sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RANDlead
- University of New Mexicocollaborator
- Boston Medical Centercollaborator
- First Choice Community Healthcarecollaborator
- Hidalgo Medical Servicescollaborator
- National Institute of Mental Health (NIMH)collaborator
- Stanford Universitycollaborator
- University of Pittsburghcollaborator
- Saint John's Cancer Institutecollaborator
- Olive View-UCLA Education & Research Institutecollaborator
Study Sites (16)
Hubert Humphrey Comprehensive Health Center
Los Angeles, California, 90003, United States
Providence Saint John's Health Center
Santa Monica, California, 90404, United States
First Choice Community Healthcare - South Broadway Medical Center
Albuquerque, New Mexico, 87102, United States
First Choice Community Healthcare - South Valley Medical/Dental Center
Albuquerque, New Mexico, 87105, United States
First Choice - Alameda Medical Center
Albuquerque, New Mexico, 87107, United States
First Choice Community Healthcare - North Valley Medical Center
Albuquerque, New Mexico, 87107, United States
University of New Mexico Family Health Clinic, North Valley
Albuquerque, New Mexico, 87107, United States
University of New Mexico Family Health Clinic, Southeast Heights
Albuquerque, New Mexico, 87108, United States
First Choice Community Healthcare - Alamosa Medical Center
Albuquerque, New Mexico, 87121, United States
University of New Mexico Internal Medicine Clinic, Southwest Mesa
Albuquerque, New Mexico, 87121, United States
First Choice Community Healthcare - Belen Medical Center
Belen, New Mexico, 87002, United States
First Choice Community Healthcare - Edgewood Medical/Dental Center
Edgewood, New Mexico, 87015, United States
Hidalgo Medical Services - Lordsburg Clinic
Lordsburg, New Mexico, 88045, United States
First Choice Community Healthcare - Los Lunas Medical/Dental Center
Los Lunas, New Mexico, 87031, United States
Hidalgo Medical Services - Community Health Center
Silver City, New Mexico, 88061, United States
Hidalgo Medical Services - Med Square Clinic
Silver City, New Mexico, 88061, United States
Related Publications (4)
Watkins KE, Osilla KC, McCullough CM, Griffin BA, Dopp AR, Becker K, Meredith LS, Carrejo V, Hindmarch GM, Mendon-Plasek S, Christensen J, Weir R, Kelly L, Pak L, Murray-Krezan C, Tarhuni L, Crowley C, Bilder A, Kalmin MM, Schoenbaum M, Komaromy M. Collaborative Care for Opioid Use Disorder and Mental Illness: The CLARO Randomized Clinical Trial. JAMA Intern Med. 2025 Dec 29:e257036. doi: 10.1001/jamainternmed.2025.7036. Online ahead of print.
PMID: 41460640DERIVEDHindmarch G, Meredith LS, McCullough CM, Griffin BA, Watkins KE. Interpersonal Violence and Mental Health, Drug use, and Treatment Utilization among Patients with Co-Occurring Opioid use and Mental Health Disorders. Chronic Stress (Thousand Oaks). 2024 Sep 5;8:24705470241279335. doi: 10.1177/24705470241279335. eCollection 2024 Jan-Dec.
PMID: 39246736DERIVEDOsilla KC, Meredith LS, Griffin BA, Martineau M, Hindmarch G, Watkins KE. Design of CLARO+ (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses, Plus): A randomized trial of collaborative care to decrease overdose and suicide risk among patients with co-occurring disorders. Contemp Clin Trials. 2023 Sep;132:107294. doi: 10.1016/j.cct.2023.107294. Epub 2023 Jul 16.
PMID: 37454728DERIVEDOsilla KC, Dopp AR, Watkins KE, Ceballos V, Hurley B, Meredith LS, Leamon I, Jacobsohn V, Komaromy M. Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. Addict Sci Clin Pract. 2022 Apr 8;17(1):25. doi: 10.1186/s13722-022-00302-9.
PMID: 35395811DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Watkins
RAND
- PRINCIPAL INVESTIGATOR
Miriam Komaromy
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Physician Policy Researcher
Study Record Dates
First Submitted
September 8, 2020
First Posted
September 23, 2020
Study Start
January 8, 2021
Primary Completion
June 12, 2024
Study Completion
June 12, 2024
Last Updated
July 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Every 6 months (January and July) following enrollment of the first patient. First submission expected July 2021. Submission will cease following sharing of final analysis data set for any specified outcomes publications.
- Access Criteria
- Per NIMH NDA policies (https://nda.nih.gov/)
Per National Institute of Mental Health (NIMH) funding requirements, study data must be uploaded to the NIMH National Data Archive (NDA) every six months once data collection begins. A universal subject identifier called a Global Unique Identifier (GUID) will be generated for each participant. All raw data will be uploaded every six months to the NIMH NDA per their policies. Additionally, all analysis data sets used for manuscripts must be uploaded to the NIMH NDA, identified by GUID.