Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

Last updated: December 2, 2024
Sponsor: RAND
Overall Status: Completed

Phase

N/A

Condition

Depression

Opioid Use Disorder

Panic Disorders

Treatment

Collaborative Care

Clinical Study ID

NCT04559893
1UF1MH121954
1UF1MH121954
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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)

Exclusion

Exclusion Criteria:

  • Under 18

  • Does not speak English or Spanish

  • Unable to consent

  • Receiving both MOUD and psychotropic medication from a provider outside of theprimary care health system at which the patient is enrolled

  • Not receiving primary care at one of the participating clinical sites

Study Design

Total Participants: 729
Treatment Group(s): 1
Primary Treatment: Collaborative Care
Phase:
Study Start date:
January 08, 2021
Estimated Completion Date:
June 12, 2024

Study 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).

Connect with a study center

  • Clinica Sierra Vista - Baker Street Village CHC

    Bakersfield, California 93305
    United States

    Site Not Available

  • Hubert Humphrey Comprehensive Health Center

    Los Angeles, California 90003
    United States

    Site Not Available

  • Providence Saint John's Health Center

    Santa Monica, California 90404
    United States

    Site Not Available

  • Clinica Sierra Vista - Kern River Health Center

    Wofford Heights, California 93285
    United States

    Site Not Available

  • First Choice - Alameda Medical Center

    Albuquerque, New Mexico 87107
    United States

    Site Not Available

  • First Choice Community Healthcare - Alamosa Medical Center

    Albuquerque, New Mexico 87121
    United States

    Site Not Available

  • First Choice Community Healthcare - North Valley Medical Center

    Albuquerque, New Mexico 87107
    United States

    Site Not Available

  • First Choice Community Healthcare - South Broadway Medical Center

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • First Choice Community Healthcare - South Valley Medical/Dental Center

    Albuquerque, New Mexico 87105
    United States

    Site Not Available

  • University of New Mexico Family Health Clinic, North Valley

    Albuquerque, New Mexico 87107
    United States

    Site Not Available

  • University of New Mexico Family Health Clinic, Southeast Heights

    Albuquerque, New Mexico 87108
    United States

    Site Not Available

  • University of New Mexico Internal Medicine Clinic, Southwest Mesa

    Albuquerque, New Mexico 87121
    United States

    Site Not Available

  • First Choice Community Healthcare - Belen Medical Center

    Belen, New Mexico 87002
    United States

    Site Not Available

  • First Choice Community Healthcare - Edgewood Medical/Dental Center

    Edgewood, New Mexico 87015
    United States

    Site Not Available

  • Hidalgo Medical Services - Lordsburg Clinic

    Lordsburg, New Mexico 88045
    United States

    Site Not Available

  • First Choice Community Healthcare - Los Lunas Medical/Dental Center

    Los Lunas, New Mexico 87031
    United States

    Site Not Available

  • Hidalgo Medical Services - Community Health Center

    Silver City, New Mexico 88061
    United States

    Site Not Available

  • Hidalgo Medical Services - Med Square Clinic

    Silver City, New Mexico 88061
    United States

    Site Not Available

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