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Decision Aid for Opioid Use Disorder (PtDA-MAT Trial)
N/A
Recruiting
Led By Larissa Mooney, M.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the effectiveness of a tool to help people with Opioid Use Disorder, by tracking their health and drug use outcomes over 24 months.
Who is the study for?
This trial is for adults with an Opioid Use Disorder diagnosis who agree to follow study procedures, including sharing their medical and other administrative records. The study will take place in CA H&SS and includes both rural and non-rural areas.
What is being tested?
The effectiveness of the Patient Decision Aid for Opioid Use Disorder (PtDA-MAT) is being tested through a stepped-wedge cluster-randomized trial. Outcomes like drug use, overdose, healthcare utilization, treatment status, mental health, arrests, substance use, and mortality will be tracked.
What are the potential side effects?
Since this trial involves a decision aid rather than medication or invasive therapy, traditional side effects are not applicable. However, participants may experience emotional or psychological impacts from engaging with the content of the PtDA-MAT.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Opioid Use at 3 months
Opioid Use at 6 months
Treatment Retention
Secondary study objectives
Mortality
Substance Use
Treatment Adherence
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: Patient Decision AidExperimental Treatment1 Intervention
Participating clinics (and their patients) will be randomly selected to implement the intervention, at which time their patients will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.
Group II: Prior to interventionActive Control1 Intervention
All participating clinics will start with a baseline period without the intervention. The clinics and their patients will remain in the no intervention condition until randomly selected to crossover to receive the intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Decision Aid
2020
N/A
~1620
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,308,895 Total Patients Enrolled
Larissa Mooney, M.D.Principal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
121 Total Patients Enrolled
Yih-Ing Hser, Ph.D.4.08 ReviewsPrincipal Investigator - University of California, Los Angeles
University of California, Los Angeles
3 Previous Clinical Trials
37,711 Total Patients Enrolled