Prevention Interventions for Opioid Misuse

August 3, 2026 updated by: Maureen A Walton, University of Michigan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief intervention (BI) then Portal
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
Behavioral: 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.
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.
Experimental: Brief intervention (BI) then Enhanced Usual Care (EUC)
The BI will be delivered at intake and EUC will be added 4 weeks later. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
Behavioral: 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.
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.
Experimental: Enhanced Usual Care (EUC) then Portal
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
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.
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.
Active Comparator: Enhanced Usual Care (EUC) then EUC
EUC will be delivered at intake and delivered again 4 weeks later. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Misuse Severity Score (Past 3-month)
Time Frame: 3, 6, and 12 months
Alcohol Smoking and Substance Involvement Screening Test severity risk score (severity of prescription opioids/heroin consumption and consequences, scores range 0-27 per subscale; the prescription opioid and heroin subscales are summed such that total possible range on this measure is 0-54, higher score indicates worse outcomes/more severity). Note: missing data was imputed and median scores are presented.
3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overdose Risk Behaviors
Time Frame: 3, 6, and 12 months
Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes)
3, 6, and 12 months
Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days)
Time Frame: 3, 6, and 12 months
Item based on the Addiction Severity Index (modified), data was collected for days of opioid misuse and possible scores ranged from 0-60. For statistical analysis, responses were dichotomized to 0 days vs. 1+ days, thus results are presented as # of participants reporting past 30-day opioid misuse.
3, 6, and 12 months
Other Drug and Alcohol Use Severity
Time Frame: 3, 6, and 12 months
Substance use severity index (based on 7-items measuring frequency of: alcohol consumption, cannabis consumption, prescription sedative misuse, prescription stimulant misuse, cocaine consumption, methamphetamine consumption, hallucinogens consumption), sum of all 7 items with response options for each substance: 0 = never, 1= 1 time, 2= 2 times, 3= Once a month, 4= 2 to 3 times a month, 5= Once a week, 6= 2 times a week, 7= 3 to 4 times a week, 8= Nearly every day, 9= Every day, 10= More than once a day; total possible range is 0-70, higher scores indicate worse outcome/greater severity
3, 6, and 12 months
Substance Use Consequences
Time Frame: 3, 6, and 12 months
Adapted alcohol (14 items), cannabis (14 items), and/or opioid-related consequences (14 items); response options for each item on each subscale were: 0=Never, 1=1 time, 2=2 times, 3=3-5 times, 4=6-9 times, 5=10-19 times, 6=20 or more times. Measure comprises total of sum of items across 3 subscales with a possible range of 0 to 252, higher score indicates worse outcomes/more consequences
3, 6, and 12 months
Impaired Driving
Time Frame: 3, 6, and 12 months
Adapted items from Young Adult Driving Questionnaire (5 items; score ranges from 0-30; higher score indicates worse outcome)
3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Maureen Walton, PhD, University of Michigan
  • Principal Investigator: Erin Bonar, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Actual)

April 14, 2025

Study Completion (Actual)

April 14, 2025

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00177625
  • UG3DA050173 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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