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Collaborative Care for Opioid Use Disorder

N/A

Waitlist Available

Led By Katherine Watkins, MD

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed over the previous 30 days at study entry and at 3 and 6 months after study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed over the previous 30 days at study entry and at 3 and 6 months after study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed over the previous 30 days at study entry and at 3 and 6 months after study entry for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MOUD continuity of care

Secondary study objectives

Opioid overdose risk behaviors

Suicide risk

Other study objectives

Therapeutic procedure

Alcohol use severity

Clinician (care coordinator) communication

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Collaborative care Plus

2022

N/A

~70

0 / 4Eligibility criteria met