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Prevention Interventions for Opioid Use Disorder

N/A
Waitlist Available
Led By Erin Bonar, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Medically & cognitively able to provide consent or assent
Aged 16-30 years
Must not have
Presenting with acute sexual assault, acute suicidality or a current cancer diagnosis/are currently receiving cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will develop and test interventions to prevent opioid misuse and addiction in young adults ages 16-30, initiated during an emergency department visit and continued post-discharge via telehealth.

Who is the study for?
This trial is for young people aged 16-30 who visit a Michigan Medicine emergency department, can communicate in English, and are able to consent. They must have used prescription opioids and have at least one risk factor like drug misuse or depression. Pregnant individuals, those with recent injection drug use, acute sexual assault victims, suicidal individuals, or current cancer patients are excluded.
What is being tested?
The study tests prevention strategies for opioid misuse among older adolescents and young adults using brief interventions (BI), a portal system for follow-up care, and enhanced usual care (EUC). It aims to identify cost-effective methods that prevent the development of opioid use disorders after an emergency department visit.
What are the potential side effects?
Since this trial focuses on preventive interventions rather than medications, it may not involve typical drug side effects. However, participants might experience discomfort during discussions about personal substance use or emotional distress related to intervention content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mentally capable of understanding and agreeing to participate.
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I am between 16 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently dealing with an acute sexual assault, feeling acutely suicidal, or am diagnosed with/receiving treatment for cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in opioid misuse
Secondary study objectives
Change in days of opioid misuse
Change in impaired driving
Change in other drug and alcohol use
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Usual Care (EUC) then PortalExperimental Treatment2 Interventions
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Group II: Brief intervention (BI) then PortalExperimental Treatment2 Interventions
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Group III: Brief intervention (BI) then Enhanced Usual Care (EUC)Experimental Treatment2 Interventions
The BI will be delivered at intake and EUC will be added 4 weeks later.
Group IV: Enhanced Usual Care (EUC) then EUCActive Control1 Intervention
EUC will be delivered at intake and delivered again 4 weeks later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Portal
2011
N/A
~100
Enhanced Usual Care (EUC)
2015
Completed Phase 1
~4280

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,860 Previous Clinical Trials
6,436,765 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,594 Previous Clinical Trials
3,327,581 Total Patients Enrolled
Erin Bonar, PhDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
1,700 Total Patients Enrolled
Maureen Walton, PhDPrincipal InvestigatorUniversity of Michigan

Media Library

Brief intervention (BI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04550715 — N/A
~69 spots leftby Mar 2025
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