Clinical trial NCT04559893: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses
Official title: 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
Keywords: Collaborative care
Problem solving therapy
Written exposure therapy
Medication for addiction treatment
Addiction
Opioid-use disorder
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: Boston Medical Center
name: First Choice Community Healthcare
name: Hidalgo Medical Services
name: National Institute of Mental Health (NIMH)
name: Stanford University
name: University of Pittsburgh
name: Saint John's Cancer Institute
name: Olive View-UCLA Education & Research Institute
First posted: 2020-09-23
Enrollment: 729
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: 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).

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
measure: MOUD access
timeFrame: Assessed over the first 30 days after study entry
measure: Major Depressive Disorder (MDD) symptoms
timeFrame: Assessed over the previous 2 weeks at study entry and at 3 and 6 months after study entry
measure: Post-traumatic Stress Disorder (PTSD) symptoms
timeFrame: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
Secondary outcomes:
measure: Drug use frequency
timeFrame: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
measure: Opioid use severity
timeFrame: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
measure: Alcohol use frequency
timeFrame: Assessed over the previous 3 months at study entry and at 3 and 6 months after study entry
measure: Opioid overdose events
timeFrame: Assessed over the previous 3 months at study entry and at 3 and 6 months after study entry
measure: Suicidality
timeFrame: Assessed over the previous 30 days at 3 and 6 months after study entry
measure: All-cause mortality
timeFrame: Assessed over the first 180 days after study entry
measure: MOUD initiation
timeFrame: Assessed over the first 14 days after study entry
measure: MOUD engagement
timeFrame: Assessed over the first 34 days after study entry
measure: Access to MDD and/or PTSD treatment
timeFrame: Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
measure: Quality of care for MDD
timeFrame: Assessed over the first 12 weeks after study entry
measure: Quality of care for PTSD
timeFrame: Assessed over the first 60 days after study entry
Other outcomes:
measure: Demographics
timeFrame: Asked about present state at time of measurement; assessed at study entry
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 study entry and at 3 and 6 months after study entry
measure: History of MOUD treatment
timeFrame: Asked about lifetime MOUD treatment; assessed at study entry
measure: Current 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 study entry
measure: Homelessness
timeFrame: Assessed over the previous 3 months at study entry
measure: Legal involvement
timeFrame: Asked about lifetime legal involvement; assessed at study entry and at 3 and 6 months after study entry
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 study entry
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 manager working alliance
timeFrame: Assessed over the previous 3 months at 3 months after study entry
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: MDD remission
timeFrame: Assessed over the previous 2 weeks at 3 and 6 months after study entry
measure: MDD response
timeFrame: Assessed over the previous 2 weeks at 3 and 6 months after study entry
measure: PTSD remission
timeFrame: Assessed over the previous 30 days at 3 and 6 months after study entry
measure: PTSD response
timeFrame: Assessed over the previous 30 days at 3 and 6 months after study entry
measure: General health functioning
timeFrame: Assessed over the previous 30 days at study entry and at 3 and 6 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: Albuquerque
country: United States
facility: University of New Mexico Internal Medicine Clinic, Southwest Mesa
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: Lordsburg
country: United States
facility: Hidalgo Medical Services - Lordsburg Clinic
state: New Mexico
city: Los Lunas
country: United States
facility: First Choice Community Healthcare - Los Lunas Medical/Dental Center
state: New Mexico
city: Silver City
country: United States
facility: Hidalgo Medical Services - Community Health Center
state: New Mexico
city: Silver City
country: United States
facility: Hidalgo Medical Services - Med Square Clinic
state: New Mexico
Study officials:
affiliation: RAND
name: Katherine Watkins
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Miriam Komaromy
role: PRINCIPAL_INVESTIGATOR
References:
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.