Opioid-use DisorderCLARONCT04559893
Collaboration Leading to Addiction Treatment and Recovery From Other Stresses
A study testing Collaborative Care in people with Opioid-use Disorder and Addiction, run by RAND at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Addiction, Depression
- What is being tested?
- Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 729 participants
- Where
- 16 sitesUnited States
- Study dates
- 8 Jan 2021to 12 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 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)
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
First Choice Community Healthcare - South Broadway Medical Center
Albuquerque, New Mexico, 87102
First Choice Community Healthcare - South Valley Medical/Dental Center
Albuquerque, New Mexico, 87105
First Choice - Alameda Medical Center
Albuquerque, New Mexico, 87107
First Choice Community Healthcare - North Valley Medical Center
Albuquerque, New Mexico, 87107
University of New Mexico Family Health Clinic, North Valley
Albuquerque, New Mexico, 87107
University of New Mexico Family Health Clinic, Southeast Heights
Albuquerque, New Mexico, 87108
First Choice Community Healthcare - Alamosa Medical Center
Albuquerque, New Mexico, 87121
University of New Mexico Internal Medicine Clinic, Southwest Mesa
Albuquerque, New Mexico, 87121
First Choice Community Healthcare - Belen Medical Center
Belen, New Mexico, 87002
First Choice Community Healthcare - Edgewood Medical/Dental Center
Edgewood, New Mexico, 87015
Hidalgo Medical Services - Lordsburg Clinic
Lordsburg, New Mexico, 88045
Hubert Humphrey Comprehensive Health Center
Los Angeles, California, 90003
First Choice Community Healthcare - Los Lunas Medical/Dental Center
Los Lunas, New Mexico, 87031
Providence Saint John's Health Center
Santa Monica, California, 90404
Hidalgo Medical Services - Community Health Center
Silver City, New Mexico, 88061
Hidalgo Medical Services - Med Square Clinic
Silver City, New Mexico, 88061
About this study
Official title: Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness
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.
Read the detailed description
Untreated mental illness and substance use disorders are prevalent and can have devastating consequences for the individual, their families and the community. Co-occurring opioid use disorders (OUD) with either depressive disorders and/or post-traumatic stress disorder (PTSD) are of particular concern, because depression and PTSD are prevalent in people with OUD, co-occurring mental illness is linked to an increased risk for opioid misuse and overdose, and because of the high prevalence of the chronic use of prescription opioids in individuals with mental illness, a risk factor for heroin use and the development of an OUD. Primary care is an important and underutilized setting in which to provide treatment for all three disorders, because OUD, depression and PTSD are frequently co-morbid with medical conditions. However, despite the effectiveness of treatments for all three disorders, many individuals never receive treatment; and, when treatment is provided, quality is low. With the rising number of opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. Collaborative care (CC) has never been tested with co-occurring disorders (COD), despite research by our team suggesting it may be effective. CC 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 CC model for COD (CC-COD), the CC team also includes a behavioral health psychotherapist (BHP); the evidence-based treatments supported include medications for OUD (MOUD), pharmacotherapy for depression and PTSD, motivational interviewing (MI), problem solving therapy (PST) and Written Exposure Therapy (WET).
The current study consists of a multi-site, randomized pragmatic trial in rural and urban primary care clinics located in Health Professional Shortage Areas (HPSA) of New Mexico and California to adapt, harmonize and then test whether CC-COD improves access, quality and outcomes for primary care patients with co-morbid OUD and depression and/or PTSD. The study will randomize 900 patients with co-occurring OUD and depression disorder and/or PTSD to receive either CC-COD or enhanced usual care (EUC).
- Being tested
- Collaborative Care
- Keywords
- Collaborative care, Problem solving therapy, Written exposure therapy, Medication for addiction treatment, Addiction, Opioid-use disorder
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care | Experimental | Intervention is administered to patients in this arm. Care to be delivered via collaborative care. Receives: Behavioral: Collaborative Care |
| Control | No intervention | Patients in this arm will receive enhanced usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 6 months after study entry.
Secondary outcomes (12)
Access to MDD and/or PTSD treatment
Receipt of medication and/or behavioral treatment associated with an MDD or PTSD diagnosis within 30 days of study enrollment (initial) or within 180 days of study enrollment (any) for study participants who did not have any visits (behavioral health treatment or medication) for MDD and/or PTSD in 30 days prior to study enrollment. Obtained from patient survey and electronic medical records.
Measured: Assessed at 30 days and 180 days after study entry.
Quality of care for MDD
Four psychotherapy visits in the first six months or an adequate (60 day) medication trial for new episodes of MDD care (completed within 6 months) for study participants with probable MDD at baseline and a new episode of MDD care (no MDD care for at least 30 days prior to enrollment). Obtained from patient survey and electronic medical records.
Measured: Assessed at 6 months after study entry.
Quality of care for PTSD
Four psychotherapy visits in the first six months or an adequate (60 days) medication trial for new episodes of PTSD care (completed within 6 months) for study participants with probable PTSD at baseline, and a new episode of PTSD care (no PTSD care for at least 30 days prior to enrollment). Obtained from patient survey and electronic medical records.
Measured: Assessed at 6 months after study entry.
MDD remission
Binary measure based on sum of items (0-27) in the PHQ-9. PHQ-9 score less than 5 at 6 months for study participants with probable MDD at baseline.
Measured: Assessed at 6 months after study entry
MDD response
Binary measure based on sum of items (0-27) in the PHQ-9. PHQ-9 score at 6 months less than 50% of baseline score for participants with probable MDD at baseline.
Measured: Assessed at 6 months after study entry.
PTSD remission
Binary measure based on sum of items (0-80) in the PCL-5. PCL-5 score less than 34 at 6 months for study participants with probable PTSD at baseline.
Measured: Assessed at 6 months after study entry.
PTSD response
Binary measure based on sum of items (0-80) in the PCL-5. PCL-5 score at 6 months less than 50% of baseline score for study participants with probable PTSD at baseline.
Measured: Assessed at 6 months after study entry.
Active suicidal ideation
Dichotomized Columbia Suicide Severity Rating Scale at 6 months. Endorsed if participants answer YES to Question 3, 4, and/or 5 and/or YES to Question 7. Obtained from patient survey.
Measured: Assessed at 6 months after study entry.
Opioid use frequency
Days of opioid use in the past 30 days from National Survey on Drug Use and Health. Obtained from patient survey.
Measured: Assessed over 30 days after study entry.
Opioid overdose events
Opioid overdose events (at least 1 event) in the previous three months. Obtained from patient survey.
Measured: Assessed over the previous 3 months after study entry.
Physical health functioning
Physical health measured using the component scores from the Veterans RAND 12-item Health Survey (VR-12) physical health subscale.
Measured: Assessed at 30 days after study entry
Mental health functioning
Mental health functioning measured using the component scores from the Veterans RAND 12-item Health Survey (VR-12) mental health subscale.
Measured: Assessed at 30 days after study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start8 Jan 2021
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- 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
- Two-arm randomized control trial (RCT) where participants are randomly assigned to intervention or control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 729 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Boston Medical Center, First Choice Community Healthcare, Hidalgo Medical Services, National Institute of Mental Health (NIMH), Stanford University, University of Pittsburgh, Saint John's Cancer Institute, Olive View-UCLA Education & Research Institute
- Responsible party
- Principal investigator, Katherine Watkins, RAND
- Investigators
- Katherine Watkins, Principal investigator, RANDMiriam Komaromy, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559893
- Sponsor's protocol ID
- 1UF1MH121954
- Other IDs
- 1UF1MH121954
- Acronym
- CLARO
- Status last verified
- Jul 2025
- First submitted
- 8 Sep 2020
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Komaromy M, Meredith LS, Rabinowitz M, McCullough C, Kelly L, Griffin BA, Mendon-Plasek S, Watkins KE. Higher suicidality among primary care patients who have opioid use disorder and co-occurring depression and/or PTSD. BMC Prim Care. 2026 Feb 24;27(1):113. doi: 10.1186/s12875-026-03217-5.
PubMed 41735843Watkins 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. 2026 Feb 1;186(2):168-180. doi: 10.1001/jamainternmed.2025.7036.
PubMed 41460640Kelly L, Hindmarch GM, Watkins KE, McCullough CM, Griffin BA, Meredith LS, Mendon-Plasek S, Komaromy M, Hunter SB. Association between housing status and mental health and substance use severity among individuals with opioid use disorder and co-occurring depression and/or PTSD. BMC Prim Care. 2025 Aug 8;26(1):250. doi: 10.1186/s12875-025-02947-2.
PubMed 40781589Hindmarch GM, Osilla KC, Dopp AR, Becker K, Miller V, Kelly L, Christensen J, Chitwood-Sedore V, Komaromy M, Watkins KE. A Qualitative Study of Patients' Experiences With Collaborative Care for Co-occurring Opioid Use and Mental Health Disorders in Primary Care. J Addict Med. 2026 Jan-Feb 01;20(1):53-61. doi: 10.1097/ADM.0000000000001511. Epub 2025 May 19.
PubMed 40387109Hindmarch 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.
PubMed 39246736Osilla 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.
PubMed 37454728Osilla 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.
PubMed 35395811
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness
- ClinicalTrials.gov ID
- NCT04559893
- Acronym / sponsor ID
- CLARO / 1UF1MH121954
- Keywords
- Collaborative care, Problem solving therapy, Written exposure therapy, Medication for addiction treatment, Addiction, Opioid-use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 729 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- University of New Mexico, Boston Medical Center, First Choice Community Healthcare, Hidalgo Medical Services, National Institute of Mental Health (NIMH), Stanford University, University of Pittsburgh, Saint John's Cancer Institute, Olive View-UCLA Education & Research Institute
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Untreated mental illness and substance use disorders are prevalent and can have devastating consequences for the individual, their families and the community. Co-occurring opioid use disorders (OUD) with either depressive disorders and/or post-traumatic stress disorder (PTSD) are of particular concern, because depression and PTSD are prevalent in people with OUD, co-occurring mental illness is linked to an increased risk for opioid misuse and overdose, and because of the high prevalence of the chronic use of prescription opioids in individuals with mental illness, a risk factor for heroin use and the development of an OUD. Primary care is an important and underutilized setting in which to provide treatment for all three disorders, because OUD, depression and PTSD are frequently co-morbid with medical conditions. However, despite the effectiveness of treatments for all three disorders, many individuals never receive treatment; and, when treatment is provided, quality is low. With the rising number of opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. Collaborative care (CC) has never been tested with co-occurring disorders (COD), despite research by our team suggesting it may be effective. CC 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 CC model for COD (CC-COD), the CC team also includes a behavioral health psychotherapist (BHP); the evidence-based treatments supported include medications for OUD (MOUD), pharmacotherapy for depression and PTSD, motivational interviewing (MI), problem solving therapy (PST) and Written Exposure Therapy (WET).
The current study consists of a multi-site, randomized pragmatic trial in rural and urban primary care clinics located in Health Professional Shortage Areas (HPSA) of New Mexico and California to adapt, harmonize and then test whether CC-COD improves access, quality and outcomes for primary care patients with co-morbid OUD and depression and/or PTSD. The study will randomize 900 patients with co-occurring OUD and depression disorder and/or PTSD to receive either CC-COD or enhanced usual care (EUC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized control trial (RCT) where participants are randomly assigned to intervention or control.
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care | Experimental | Behavioral: Collaborative CareIntervention is administered to patients in this arm. Care to be delivered via collaborative care. |
| Control | No intervention | –Patients in this arm will receive enhanced usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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)
Key exclusion criteria (5 listed)
- 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
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 CareCollaborative 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. | Behavioural | Collaborative Care |
Primary outcome
Buprenorphine access
Time frame: Assessed at 6 months after study entry.
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.
Buprenorphine continuity of care
Time frame: Assessed at 6 months after study entry.
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.
Major Depressive Disorder (MDD) symptom severity
Time frame: Assessed at 6 months after study entry.
Sum of items (0-27) in the PHQ-9 (Patient Health Questionnaire) at 6 months for participants with probable major depression at baseline.
Post-traumatic Stress Disorder (PTSD) symptom severity
Time frame: Assessed at 6 months after study entry.
Sum of items (0-80) in PCL-5 at 6 months for study participants with probable PTSD at baseline.
12 secondary outcomes
Access to MDD and/or PTSD treatment
Time frame: Assessed at 30 days and 180 days after study entry.
Quality of care for MDD
Time frame: Assessed at 6 months after study entry.
Quality of care for PTSD
Time frame: Assessed at 6 months after study entry.
MDD remission
Time frame: Assessed at 6 months after study entry
MDD response
Time frame: Assessed at 6 months after study entry.
PTSD remission
Time frame: Assessed at 6 months after study entry.
PTSD response
Time frame: Assessed at 6 months after study entry.
Active suicidal ideation
Time frame: Assessed at 6 months after study entry.
Opioid use frequency
Time frame: Assessed over 30 days after study entry.
Opioid overdose events
Time frame: Assessed over the previous 3 months after study entry.
Physical health functioning
Time frame: Assessed at 30 days after study entry
Mental health functioning
Time frame: Assessed at 30 days after study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Derived from this study: PubMed 41735843Komaromy M, Meredith LS, Rabinowitz M, McCullough C, Kelly L, Griffin BA, Mendon-Plasek S, Watkins KE. Higher suicidality among primary care patients who have opioid use disorder and co-occurring depression and/or PTSD. BMC Prim Care. 2026 Feb 24;27(1):113. doi: 10.1186/s12875-026-03217-5.
- Derived from this study: PubMed 41460640Watkins 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. 2026 Feb 1;186(2):168-180. doi: 10.1001/jamainternmed.2025.7036.
- Derived from this study: PubMed 40781589Kelly L, Hindmarch GM, Watkins KE, McCullough CM, Griffin BA, Meredith LS, Mendon-Plasek S, Komaromy M, Hunter SB. Association between housing status and mental health and substance use severity among individuals with opioid use disorder and co-occurring depression and/or PTSD. BMC Prim Care. 2025 Aug 8;26(1):250. doi: 10.1186/s12875-025-02947-2.
- Derived from this study: PubMed 40387109Hindmarch GM, Osilla KC, Dopp AR, Becker K, Miller V, Kelly L, Christensen J, Chitwood-Sedore V, Komaromy M, Watkins KE. A Qualitative Study of Patients' Experiences With Collaborative Care for Co-occurring Opioid Use and Mental Health Disorders in Primary Care. J Addict Med. 2026 Jan-Feb 01;20(1):53-61. doi: 10.1097/ADM.0000000000001511. Epub 2025 May 19.
- Derived from this study: PubMed 39246736Hindmarch 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.
- Derived from this study: PubMed 37454728Osilla 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.
- Derived from this study: PubMed 35395811Osilla 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Katherine Watkins principal investigator
RAND
Miriam Komaromy principal investigator
Boston Medical Center
16 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 in people with Opioid-use Disorder and Addiction, run by RAND at 16 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 5 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 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Buprenorphine access (time frame: Assessed at 6 months after study entry.). The study lists 4 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 NCT04559893, which also lists 7 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 15 Jul 2025.