NCT04634279

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

November 2, 2020

Last Update Submit

August 6, 2024

Conditions

Opioid-use DisorderAddictionDepressionPost Traumatic Stress DisorderSuicidal Ideation

Keywords

Collaborative careProblem Solving TherapyWritten Exposure TherapyMedication for addiction treatmentAddictionOpioid use disorderSuicide preventionOverdose prevention

Outcome Measures

Primary Outcomes (1)

  • 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

    Assessed over the first 180 days after study entry

Secondary Outcomes (2)

  • Opioid overdose risk behaviors

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

  • Suicide risk

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

Other Outcomes (15)

  • Demographics

    Assessed at enrollment

  • Alcohol use severity

    Assessed over the previous 3 months at study entry

  • Pain levels

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

  • +12 more other outcomes

Study Arms (2)

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.

Behavioral: Collaborative care Plus

Control

NO INTERVENTION

Patients in this arm will receive enhanced usual care.

Interventions

Collaborative care PlusBEHAVIORAL

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.

Collaborative Care Plus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hubert Humphrey Comprehensive Health Center

Los Angeles, California, 90003, United States

Location

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

First Choice Community Healthcare - South Broadway Medical Center

Albuquerque, New Mexico, 87102, United States

Location

First Choice Community Healthcare - South Valley Medical/Dental Center

Albuquerque, New Mexico, 87105, United States

Location

First Choice - Alameda Medical Center

Albuquerque, New Mexico, 87107, United States

Location

First Choice Community Healthcare - North Valley Medical Center

Albuquerque, New Mexico, 87107, United States

Location

University of New Mexico Family Health Clinic, North Valley

Albuquerque, New Mexico, 87107, United States

Location

University of New Mexico Family Health Clinic, Southeast Heights

Albuquerque, New Mexico, 87108, United States

Location

First Choice Community Healthcare - Alamosa Medical Center

Albuquerque, New Mexico, 87121, United States

Location

First Choice Community Healthcare - Belen Medical Center

Belen, New Mexico, 87002, United States

Location

First Choice Community Healthcare - Edgewood Medical/Dental Center

Edgewood, New Mexico, 87015, United States

Location

First Choice Community Healthcare - Los Lunas Medical/Dental Center

Los Lunas, New Mexico, 87031, United States

Location

Related Publications (6)

  • 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.

    PMID: 31692644BACKGROUND

  • 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.

    PMID: 21041616BACKGROUND

  • 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.

    PMID: 30784952BACKGROUND

  • 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.

    PMID: 3262956BACKGROUND

  • Watkins 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. 2025 Dec 29:e257036. doi: 10.1001/jamainternmed.2025.7036. Online ahead of print.

    PMID: 41460640DERIVED

  • 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.

    PMID: 35395811DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersBehavior, AddictiveDepressionStress Disorders, Post-TraumaticSuicidal IdeationSuicide Prevention

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehaviorBehavioral SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersSuicideSelf-Injurious Behavior

Study Officials

  • Katherine Watkins, MD

    RAND

    PRINCIPAL INVESTIGATOR

  • Miriam Komaromy

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm randomized control trial (RCT) where participants are randomly assigned to intervention or control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 18, 2020

Study Start

August 31, 2022

Primary Completion

June 12, 2024

Study Completion

June 12, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Every 6 months (January and July) following enrollment of the first patient. First submission expected July 2021. Submission will cease following sharing of final analysis data set for any specified outcomes publications.
Access Criteria
Per NIMH NDA policies
More information

Locations

US(12)