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Collaborative Care for Opioid Use Disorder

N/A
Waitlist Available
Led By Miriam Komaromy
Research Sponsored by RAND
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 and older
Be older than 18 years old
Must not have
Unable to consent
Under 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up asked about lifetime legal involvement; assessed at baseline and at 3 and 6 months
Awards & highlights

Summary

This trial will develop and test an intervention to reduce the risk of suicide and overdose among people with opioid use disorder and PTSD/depression.

Who is the study for?
This trial is for adults over 18 with opioid use disorder (OUD) and co-occurring mental health issues like depression or PTSD. Participants must be getting primary care at a participating site and able to consent. It's not for those under 18, non-English/Spanish speakers, or those treated outside the primary care system.Check my eligibility
What is being tested?
The study tests an enhanced collaborative care approach designed to lower suicide and overdose risks in individuals with OUD plus PTSD/depression. This builds on the parent CLARO study by adding more support for patients' complex needs.See study design
What are the potential side effects?
Since this trial focuses on a care approach rather than medication, side effects are not typical as with drug trials but may include discomfort from discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent by myself.
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I am younger than 18 years old.
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I do not speak English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed over the previous 7 days at enrollment and at 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed over the previous 7 days at enrollment and at 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MOUD continuity of care
Secondary outcome measures
Opioid overdose risk behaviors
Suicide risk
Other outcome measures
Therapeutic procedure
Alcohol use severity
Clinician (care coordinator) communication
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Collaborative Care PlusExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Patients in this arm will receive enhanced usual care.

Find a Location

Who is running the clinical trial?

Providence Saint John's Health CenterUNKNOWN
1 Previous Clinical Trials
900 Total Patients Enrolled
University of PittsburghOTHER
1,737 Previous Clinical Trials
16,338,957 Total Patients Enrolled
University of New MexicoOTHER
376 Previous Clinical Trials
3,528,357 Total Patients Enrolled

Media Library

Collaborative care Plus Clinical Trial Eligibility Overview. Trial Name: NCT04634279 — N/A
Opioid Use Disorder Research Study Groups: Collaborative Care Plus, Control
Opioid Use Disorder Clinical Trial 2023: Collaborative care Plus Highlights & Side Effects. Trial Name: NCT04634279 — N/A
Collaborative care Plus 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634279 — N/A
~106 spots leftby Jul 2025