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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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