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Clinical Trials/NCT04550715
NCT04550715
Completed
Not Applicable

Optimized Interventions to Prevent Opioid Use Disorder Among Adolescents and Young Adults in the Emergency Department

University of Michigan1 site in 1 country1,155 target enrollmentJanuary 4, 2021

Overview

Phase
Not Applicable
Intervention
Portal
Conditions
Opioid Use
Sponsor
University of Michigan
Enrollment
1155
Locations
1
Primary Endpoint
Change in opioid misuse
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

The purpose of the study is to develop and test innovative interventions to prevent the development of opioid misuse and opioid use disorders among older adolescents and young adults (AYA; ages 16-30) who use opioids, which will be initiated from a health care visit in the emergency department and extended post discharge via a telehealth approach. This study will have significant impact by identifying optimal, cost-effective opioid prevention strategies to sustain outcomes among AYAs.

Registry
clinicaltrials.gov
Start Date
January 4, 2021
End Date
April 14, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maureen A Walton

Professor of Psychiatry

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Aged 16-30 years
  • Seeking care in Michigan Medicine emergency department (ED)
  • Ability to read/comprehend and communicate in English
  • Medically \& cognitively able to provide consent or assent
  • Prescription opioid use plus \>=1 other risk factor (misuse positive for marijuana, other illicit drugs, other prescription drug misuse; binge drinking; depression or suicidality) or opioid misuse \[prescription opioid misuse or illicit opioid use (e.g., heroin, fentanyl)\]

Exclusion Criteria

  • Presenting with acute sexual assault, acute suicidality or a current cancer diagnosis/are currently receiving cancer treatment
  • Current pregnancy at baseline
  • History of injection drug use within last 12 months
  • High risk for opioid use disorder
  • Enrolled in Aim 1

Arms & Interventions

Enhanced Usual Care (EUC) then Portal

EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.

Intervention: Portal

Enhanced Usual Care (EUC) then Portal

EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.

Intervention: Enhanced Usual Care (EUC)

Brief intervention (BI) then Portal

The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.

Intervention: Brief intervention (BI)

Brief intervention (BI) then Portal

The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.

Intervention: Portal

Brief intervention (BI) then Enhanced Usual Care (EUC)

The BI will be delivered at intake and EUC will be added 4 weeks later.

Intervention: Brief intervention (BI)

Brief intervention (BI) then Enhanced Usual Care (EUC)

The BI will be delivered at intake and EUC will be added 4 weeks later.

Intervention: Enhanced Usual Care (EUC)

Enhanced Usual Care (EUC) then EUC

EUC will be delivered at intake and delivered again 4 weeks later.

Intervention: Enhanced Usual Care (EUC)

Outcomes

Primary Outcomes

Change in opioid misuse

Time Frame: 3, 6, and 12 months

Alcohol Smoking and Substance Involvement Screening Test severity score (prescription opioids/heroin, scores range 0-27 per subscale, higher score indicates worse outcomes)

Secondary Outcomes

  • Change in overdose risk behaviors(3, 6, and 12 months)
  • Change in substance use consequences(3, 6, and 12 months)
  • Change in other drug and alcohol use(3, 6, and 12 months)
  • Change in impaired driving(3, 6, and 12 months)
  • Change in days of opioid misuse(3, 6, and 12 months)

Study Sites (1)

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