Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1155 participants
INTERVENTIONAL
2021-01-04
2025-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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Brief intervention (BI) then Portal
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Brief intervention (BI)
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.
Portal
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 Enhanced Usual Care (EUC)
The BI will be delivered at intake and EUC will be added 4 weeks later.
Brief intervention (BI)
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.
Enhanced Usual Care (EUC)
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.
Enhanced Usual Care (EUC) then Portal
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Portal
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.
Enhanced Usual Care (EUC)
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.
Enhanced Usual Care (EUC) then EUC
EUC will be delivered at intake and delivered again 4 weeks later.
Enhanced Usual Care (EUC)
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.
Interventions
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Brief intervention (BI)
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.
Portal
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.
Enhanced Usual Care (EUC)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Current pregnancy at baseline
* History of injection drug use within last 12 months
* High risk for opioid use disorder
* Enrolled in Aim 1
16 Years
30 Years
ALL
No
Sponsors
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University of Michigan
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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Maureen A Walton
Professor of Psychiatry
Principal Investigators
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Maureen Walton, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Erin Bonar, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HUM00177625
Identifier Type: -
Identifier Source: org_study_id
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