Clinical trial NCT04634279: Competitive Revision for CLARO: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses
Official title: Competitive Revision for Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Addiction
Depression
Post Traumatic Stress Disorder
Suicidal Ideation
Keywords: Collaborative care
Problem Solving Therapy
Written Exposure Therapy
Medication for addiction treatment
Addiction
Opioid use disorder
Suicide prevention
Overdose prevention
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of New Mexico
name: Boston Medical Center
name: Hidalgo Medical Services
name: First Choice Community Healthcare
name: Stanford University
name: University of Pittsburgh
name: Olive View-UCLA Education & Research Institute
name: Saint John's Cancer Institute
First posted: 2020-11-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized control trial (RCT) where participants are randomly assigned to intervention or control.
Primary purpose: TREATMENT

Brief 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. The parent study is CLARO, Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (NCT04559893).

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.

Eligibility criteria: 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

Primary outcomes:
measure: MOUD continuity of care
timeFrame: Assessed over the first 180 days after study entry
Secondary outcomes:
measure: Opioid overdose risk behaviors
timeFrame: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
measure: Suicide risk
timeFrame: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
Other outcomes:
measure: Demographics
timeFrame: Assessed at enrollment
measure: Alcohol use severity
timeFrame: Assessed over the previous 3 months at study entry
measure: Pain levels
timeFrame: Assessed over the previous 7 days at enrollment and at 3 and 6 months
measure: History of MOUD treatment
timeFrame: Asked about lifetime MOUD treatment; assessed at baseline
measure: Current Major Depressive Disorder (MDD)/PTSD treatment
timeFrame: Assessed over the previous 30 days at study entry
measure: Prior experience with a care coordinator
timeFrame: Assessed over the previous 12 months at study entry
measure: Interpersonal support
timeFrame: Asked about present state at time of measurement; assessed at enrollment
measure: Homelessness
timeFrame: Assessed over the previous 3 months at study entry
measure: Legal involvement
timeFrame: Asked about lifetime legal involvement; assessed at baseline and at 3 and 6 months
measure: Disability and impairment
timeFrame: Assessed over the previous 7 days at study entry
measure: Rurality
timeFrame: Asked about present state at time of measurement; assessed at baseline
measure: Clinician (care coordinator) communication
timeFrame: Assessed over the previous 3 months at 3 months after study entry
measure: Ability to access treatment quickly
timeFrame: Assessed over the previous 3 months at 3 months after study entry
measure: Satisfaction with treatment
timeFrame: Assessed over the previous 3 months at 3 months after study entry
measure: Patient-care coordinator working alliance
timeFrame: Assessed over the previous 3 months at 3 months after study entry
Locations:
city: Los Angeles
country: United States
facility: Hubert Humphrey Comprehensive Health Center
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center
state: California
city: Albuquerque
country: United States
facility: First Choice Community Healthcare - South Broadway Medical Center
state: New Mexico
city: Albuquerque
country: United States
facility: First Choice Community Healthcare - South Valley Medical/Dental Center
state: New Mexico
city: Albuquerque
country: United States
facility: First Choice - Alameda Medical Center
state: New Mexico
city: Albuquerque
country: United States
facility: First Choice Community Healthcare - North Valley Medical Center
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Family Health Clinic, North Valley
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Family Health Clinic, Southeast Heights
state: New Mexico
city: Albuquerque
country: United States
facility: First Choice Community Healthcare - Alamosa Medical Center
state: New Mexico
city: Belen
country: United States
facility: First Choice Community Healthcare - Belen Medical Center
state: New Mexico
city: Edgewood
country: United States
facility: First Choice Community Healthcare - Edgewood Medical/Dental Center
state: New Mexico
city: Los Lunas
country: United States
facility: First Choice Community Healthcare - Los Lunas Medical/Dental Center
state: New Mexico
Study officials:
affiliation: RAND
name: Katherine Watkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Miriam Komaromy
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ilgen 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.
citation: Jones 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.
citation: Moscicki 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.
citation: Osilla 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.