Opioid-use DisorderNCT04634279
Competitive Revision for CLARO: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses
A study testing Collaborative care Plus in people with Opioid-use Disorder and Addiction, run by RAND at 12 sites in United States.
Trial summary
The purpose of this study is to develop and then test an enhanced version of the parent study's collaborative care intervention for co-occurring disorders (CC-COD) to reduce the risk of suicide and overdose among individuals with opioid use disorder (OUD) in combination with PTSD/depression. 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 Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Aug 2022to 12 Jun 2024
- Phase
- Interventional
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
12 sites in 1 country.
12 sites in 1 country
United States12 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
First Choice Community Healthcare - Belen Medical Center
Belen, New Mexico, 87002
First Choice Community Healthcare - Edgewood Medical/Dental Center
Edgewood, New Mexico, 87015
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
About this study
Official title: Competitive Revision for Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness
The purpose of this study is to develop and then test an enhanced version of the parent study's collaborative care intervention for co-occurring disorders (CC-COD) to reduce the risk of suicide and overdose among individuals with opioid use disorder (OUD) in combination with PTSD/depression. The parent study is CLARO, Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (NCT04559893).
Read the detailed description
People with OUD co-occurring with depression or PTSD (COD) may not seek out treatment for their substance use or mental health issues, but they do visit their primary care provider. However, because providers generally lack specialized training in substance use and mental illness and are focused on the immediate reason for the visit, patients' substance use and mental disorders often go unrecognized and untreated. This missed opportunity can have lethal consequences. Individuals with COD are at higher risk of dying from suicide or overdose than individuals with mental illness or OUD alone. The parent study (NCT04559893) will provide a definitive answer as to whether collaborative care (CC) improves access, quality, and outcomes of care for individuals with COD. While a primary goal is to improve access to and retention in medication treatment for OUD (MOUD) (which is linked to decreased mortality and overdose risk), the interventions CC-COD supports do not proactively address suicide or overdose risk, an important limitation. In addition, CC-COD does not include families in the patient's care. The investigators address these limitations and tackle the public health crisis of increasing deaths from suicide and overdose with this study. Because family members can play an important role in a patient's decision to engage with treatment and in overdose and suicide prevention, the study team investigates family members' views and use this information to strengthen CC-COD. This revision will develop and then test the incremental effectiveness of three additional CC-COD components. Care coordinators will (1) educate family members about MOUD with the goal of increasing patient retention in treatment; (2) train family members and the patient to administer naloxone and on how to reduce overdose risk behaviors; and (3) implement Caring Contacts, a suicide prevention intervention that sends compassionate mailed or text messages to individuals to decrease social isolation and reduce suicide risk.
- Conditions
- Opioid-use Disorder, Addiction, Depression, Post Traumatic Stress Disorder, Suicidal Ideation
- Being tested
- Collaborative care Plus
- Keywords
- Collaborative care, Problem Solving Therapy, Written Exposure Therapy, Medication for addiction treatment, Addiction, Opioid use disorder, Suicide prevention, Overdose prevention
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive, Depression, Stress Disorders, Post-Traumatic, Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative care PlusBehavioural
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 this model, the CC team also includes a behavioral health psychotherapist (BHP) who consults on a regular basis but does not deliver direct care. In the Collaborative Care Plus condition, the care coordinator involves family in care, teaches family about naloxone use, and provides Caring Contacts, a suicide prevention method, to patients.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care Plus | Experimental | Intervention is administered to patients in this arm. Care to be delivered via collaborative care. The supplement intervention adds family involvement in care and Caring Contacts, a suicide prevention method. Receives: Behavioral: Collaborative care Plus |
| 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.
MOUD continuity of care
Max number of continuous (i.e., no breaks of more than 7 days) days the patient receives MOUD in the 180 days after study enrollment; obtained from electronic health record (EHR) or from the Prescription Drug Monitoring Program for the State of New Mexico
Measured: Assessed over the first 180 days after study entry
Secondary outcomes (2)
Opioid overdose risk behaviors
Measured as a sum of ratings on 9 risk behaviors from Opioid Overdose Risk Assessment (score 0-36). A high score indicates high risk.
Measured: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
Suicide risk
Measured using Columbia Suicide Severity Rating Scales, classified into 6 levels (from no risk to suicide attempt)
Measured: Assessed over the previous 30 days at study entry and at 3 and 6 months 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 posted18 Nov 2020
- Study start31 Aug 2022
- 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 (6)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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of New Mexico, Boston Medical Center, Hidalgo Medical Services, First Choice Community Healthcare, Stanford University, University of Pittsburgh, Olive View-UCLA Education & Research Institute, Saint John's Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Katherine Watkins, MD, Principal investigator, RANDMiriam Komaromy, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634279
- Sponsor's protocol ID
- 3UF1MH121954-01S1
- Other IDs
- 3UF1MH121954-01S1
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2020
- Last updated
- 9 Aug 2024
- 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 identification, 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
Fendrich M, Becker J, Hernandez-Meier J. Psychiatric symptoms and recent overdose among people who use heroin or other opioids: Results from a secondary analysis of an intervention study. Addict Behav Rep. 2019 Aug 6;10:100212. doi: 10.1016/j.abrep.2019.100212. eCollection 2019 Dec.
PubMed 31692644Ilgen MA, Bohnert AS, Ignacio RV, McCarthy JF, Valenstein MM, Kim HM, Blow FC. Psychiatric diagnoses and risk of suicide in veterans. Arch Gen Psychiatry. 2010 Nov;67(11):1152-8. doi: 10.1001/archgenpsychiatry.2010.129.
PubMed 21041616Jones CM, McCance-Katz EF. Co-occurring substance use and mental disorders among adults with opioid use disorder. Drug Alcohol Depend. 2019 Apr 1;197:78-82. doi: 10.1016/j.drugalcdep.2018.12.030. Epub 2019 Feb 14.
PubMed 30784952Moscicki EK, O'Carroll P, Rae DS, Locke BZ, Roy A, Regier DA. Suicide attempts in the Epidemiologic Catchment Area Study. Yale J Biol Med. 1988 May-Jun;61(3):259-68.
PubMed 3262956Watkins 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 41460640Osilla 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