Prevention Interventions for Opioid Misuse

NCT ID: NCT04550715

Last Updated: 2026-01-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2025-04-14

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

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.

Group Type EXPERIMENTAL

Brief intervention (BI)

Intervention Type 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.

Portal

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Brief intervention (BI)

Intervention Type 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.

Enhanced Usual Care (EUC)

Intervention Type 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.

Enhanced Usual Care (EUC) then Portal

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

Group Type EXPERIMENTAL

Portal

Intervention Type BEHAVIORAL

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)

Intervention Type 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.

Enhanced Usual Care (EUC) then EUC

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

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care (EUC)

Intervention Type 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.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Responsible Party

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Maureen A Walton

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 41085955 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38331586 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34352386 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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UG3DA050173

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00177625

Identifier Type: -

Identifier Source: org_study_id

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