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Opioid UseNCT04550715

Prevention Interventions for Opioid Misuse

A study testing Brief intervention (BI) and Portal in people with Opioid Use, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 30 years
Conditions the study is for
Opioid Use
What is being tested?
Brief intervention (BI) and Portal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,155 participants
Where
1 siteUnited States
Study dates
4 Jan 2021to 14 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)]

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: 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.

Conditions
Opioid Use
Being tested
Brief intervention (BI), Portal, Enhanced Usual Care (EUC)
Keywords
opioid misuse
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief intervention (BI)Behavioural

    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.

  • PortalBehavioural

    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)Behavioural

    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.

Study groups in NCT04550715
Study groupRoleWhat they receive
Brief intervention (BI) then PortalExperimentalThe 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).
Receives: Behavioral: Brief intervention (BI); Behavioral: Portal
Brief intervention (BI) then Enhanced Usual Care (EUC)ExperimentalThe 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).
Receives: Behavioral: Brief intervention (BI); Behavioral: Enhanced Usual Care (EUC)
Enhanced Usual Care (EUC) then PortalExperimentalEUC 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).
Receives: Behavioral: Portal; Behavioral: Enhanced Usual Care (EUC)
Enhanced Usual Care (EUC) then EUCActive comparatorEUC will be delivered at intake and delivered again 4 weeks later. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
Receives: Behavioral: Enhanced Usual Care (EUC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Misuse Severity Score (Past 3-month)

    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.

    Measured: 3, 6, and 12 months

Secondary outcomes (5)

  1. Overdose Risk Behaviors

    Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes)

    Measured: 3, 6, and 12 months

  2. Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days)

    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.

    Measured: 3, 6, and 12 months

  3. Other Drug and Alcohol Use Severity

    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

    Measured: 3, 6, and 12 months

  4. Substance Use Consequences

    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

    Measured: 3, 6, and 12 months

  5. Impaired Driving

    Adapted items from Young Adult Driving Questionnaire (5 items; score ranges from 0-30; higher score indicates worse outcome)

    Measured: 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start4 Jan 2021
  3. Primary completion14 Apr 2025
  4. Study completion14 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Care provider
Enrolment
1,155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04550715
Sponsor's protocol ID
HUM00177625
Other IDs
UG3DA050173
Status last verified
Aug 2026
First submitted
25 Aug 2020
Last updated
25 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41085955

  • 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.

    PubMed 38331586

  • 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.

    PubMed 34352386

Questions about this trial

What is this clinical trial studying?

A study testing Brief intervention (BI) and Portal in people with Opioid Use, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Misuse Severity Score (Past 3-month) (time frame: 3, 6, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04550715, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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Prevention Interventions for Opioid Misuse | AzTrials