NCT04550715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2025

Completed
Last Updated

January 29, 2026

Status Verified

September 1, 2025

Enrollment Period

4.3 years

First QC Date

August 25, 2020

Last Update Submit

January 27, 2026

Conditions

Opioid Use

Keywords

opioid misuse

Outcome Measures

Primary Outcomes (1)

  • Change in opioid misuse

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

    3, 6, and 12 months

Secondary Outcomes (5)

  • Change in days of opioid misuse

    3, 6, and 12 months

  • Change in overdose risk behaviors

    3, 6, and 12 months

  • Change in other drug and alcohol use

    3, 6, and 12 months

  • Change in substance use consequences

    3, 6, and 12 months

  • Change in impaired driving

    3, 6, and 12 months

Study Arms (4)

Brief intervention (BI) then Portal

EXPERIMENTAL

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

Behavioral: Brief intervention (BI)Behavioral: Portal

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

EXPERIMENTAL

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

Behavioral: Brief intervention (BI)Behavioral: Enhanced Usual Care (EUC)

Enhanced Usual Care (EUC) then Portal

EXPERIMENTAL

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

Behavioral: PortalBehavioral: Enhanced Usual Care (EUC)

Enhanced Usual Care (EUC) then EUC

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care (EUC)

Interventions

Brief intervention (BI)BEHAVIORAL

A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.

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

Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.

Brief intervention (BI) then PortalEnhanced Usual Care (EUC) then Portal
Enhanced Usual Care (EUC)BEHAVIORAL

The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.

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

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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 \[prescription opioid misuse or illicit opioid use (e.g., heroin, fentanyl)\]

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

  • Kuklinski MR, Gibbons BJ, Bowser DM, McCollister KE, Smart R, Dunlap LJ, Shenkar E, Bonar EE, Boomer T, Campbell M, Fiellin LE, Hutton DW, Rao V, Saldana L, Su K, Walton MA, Yilmazer T. Investing in Interventions to Prevent Opioid Use Disorder in Adolescents and Young Adults: Start-up Costs from NIDA's HEAL Prevention Initiative. Prev Sci. 2025 Nov;26(7):1045-1055. doi: 10.1007/s11121-025-01835-6. Epub 2025 Oct 14.

    PMID: 41085955DERIVED

  • Seewald L, Bonar E, Bohnert ASB, Carter PM, King CA, Losman ED, Bacon L, Wheeler T, Walton M. Lifetime non-fatal overdose experiences among at-risk adolescents and young adults in the emergency department with past-year opioid use in the USA. Inj Prev. 2024 Oct 1;30(5):373-380. doi: 10.1136/ip-2023-045072.

    PMID: 38331586DERIVED

  • Bonar EE, Kidwell KM, Bohnert ASB, Bourque CA, Carter PM, Clark SJ, Glantz MD, King CA, Losman ED, McCabe SE, Philyaw-Kotov ML, Prosser LA, Voepel-Lewis T, Zheng K, Walton MA. Optimizing scalable, technology-supported behavioral interventions to prevent opioid misuse among adolescents and young adults in the emergency department: A randomized controlled trial protocol. Contemp Clin Trials. 2021 Sep;108:106523. doi: 10.1016/j.cct.2021.106523. Epub 2021 Aug 2.

    PMID: 34352386DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Maureen Walton, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Erin Bonar, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 16, 2020

Study Start

January 4, 2021

Primary Completion

April 14, 2025

Study Completion

April 14, 2025

Last Updated

January 29, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)