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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 belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to give consent by myself.
Select...
I am younger than 18 years old.
Select...
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
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 moreAwards & 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
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
1,776 Previous Clinical Trials
16,353,332 Total Patients Enrolled
University of New MexicoOTHER
384 Previous Clinical Trials
3,524,459 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent by myself.You have opioid use disorder (OUD) and also have depression and/or PTSD.I am 18 years old or older.I get my addiction and mental health medications from a doctor not in my primary care network.I am younger than 18 years old.I do not speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Collaborative Care Plus
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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