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Completed

NCT Number: NCT04634279

Competitive Revision for CLARO: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hubert Humphrey Comprehensive Health Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • 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

Treatment and study plan

Collaborative Care Plus

Behavioral

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.

Primary outcomes

  1. MOUD continuity of care

    Time frame: Assessed over the first 180 days after study entry

    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

Secondary outcomes

  1. Opioid overdose risk behaviors

    Time frame: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry

    Measured as a sum of ratings on 9 risk behaviors from Opioid Overdose Risk Assessment (score 0-36). A high score indicates high risk.

  2. Suicide risk

    Time frame: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry

    Measured using Columbia Suicide Severity Rating Scales, classified into 6 levels (from no risk to suicide attempt)

Other outcomes

  1. Demographics

    Time frame: Assessed at enrollment

    Sex, race, ethnicity, education level; assessed as moderators; obtained from patient interview

  2. Alcohol use severity

    Time frame: Assessed over the previous 3 months at study entry

    10-item AUDIT for past 3 months; assessed as a covariate; obtained from patient interview

  3. Pain levels

    Time frame: Assessed over the previous 7 days at enrollment and at 3 and 6 months

    Pain Intensity, Enjoyment of Life, General Activity (PEG) Pain Monitor for the past week; assessed as a covariate; obtained from patient interview

  4. History of MOUD treatment

    Time frame: Asked about lifetime MOUD treatment; assessed at baseline

    Assessed as a covariate; obtained from patient interview

  5. Current Major Depressive Disorder (MDD)/PTSD treatment

    Time frame: Assessed over the previous 30 days at study entry

    National Survey on Drug Use and Health (NSDUH) items; assessed as a covariate; obtained from patient interview

  6. Prior experience with a care coordinator

    Time frame: Assessed over the previous 12 months at study entry

    Assessed as a covariate; obtained from patient interview

  7. Interpersonal support

    Time frame: Asked about present state at time of measurement; assessed at enrollment

    Indicated by the patient identifying a support person with whom they interact and who does not have problematic opioid use;; obtained from patient interview

  8. Homelessness

    Time frame: Assessed over the previous 3 months at study entry

    Homelessness Screening Clinical Reminder Tool and one item from the Government Performance and Results Act (GPRA) clarifying where individuals who are homeless are currently living; assessed as a mediator; obtained from patient interview. The study team constructed a single measure from the items described. They will not be analyzed separately as two different measures.

  9. Legal involvement

    Time frame: Asked about lifetime legal involvement; assessed at baseline and at 3 and 6 months

    Items from the NSDUH and the Addiction Severity Index; assessed as a covariate; obtained from patient interview. The study team constructed a single measure from the items described. They will not be analyzed separately as two different measures.

  10. Disability and impairment

    Time frame: Assessed over the previous 7 days at study entry

    3-item Sheehan Disability Scale; assessed as a covariate; obtained from patient interview

  11. Rurality

    Time frame: Asked about present state at time of measurement; assessed at baseline

    Rural-Urban Commuting Area code associated with the participant's five-digit zip code; assessed as a moderator

  12. Clinician (care coordinator) communication

    Time frame: Assessed over the previous 3 months at 3 months after study entry

    Agency for Healthcare Research and Quality (AHRQ) Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview

  13. Ability to access treatment quickly

    Time frame: Assessed over the previous 3 months at 3 months after study entry

    AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview

  14. Satisfaction with treatment

    Time frame: Assessed over the previous 3 months at 3 months after study entry

    AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview

  15. Patient-care coordinator working alliance

    Time frame: Assessed over the previous 3 months at 3 months after study entry

    Modified Working Alliance Inventory-General Practitioner (WAI-GP); assessed as a mediator; obtained from patient interview

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Boston Medical Center
  • First Choice Community Healthcare
  • Hidalgo Medical Services
  • National Institute of Mental Health (NIMH)
  • Olive View-UCLA Education & Research Institute
  • Saint John's Cancer Institute
  • Stanford University
  • University of New Mexico
  • University of Pittsburgh

Registry information

Official study title

Competitive Revision for Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2020
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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