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OpenTrials
Completed

NCT Number: NCT04550715

Prevention Interventions for Opioid Misuse

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.

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Key information

Conditions

Opioid Use Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief intervention (BI)

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

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)

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.

Primary outcomes

  1. Opioid Misuse

    Time frame: 3, 6, and 12 months

    Alcohol Smoking and Substance Involvement Screening Test severity score (severity of prescription opioids/heroin, 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.

Secondary outcomes

  1. Overdose Risk Behaviors

    Time frame: 3, 6, and 12 months

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

  2. 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. 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

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2020
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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