Prevention Interventions for Opioid Misuse

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: Active, not recruiting
• Conditions: Opioid Use
• Intervention / Treatment: Behavioral: Brief intervention (BI); Behavioral: Portal; Behavioral: Enhanced Usual Care (EUC)

• Study Type: Interventional
• Enrollment (Actual): 1155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meredith Kotov; Phone Number: 734-232-0361; Email: mphilyaw@med.umich.edu
• Study Contact Backup: Name: Carrie Bourque; Email: csmolens@med.umich.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 28 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

How is the study designed?

Design Details

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

Number of Arms

4

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.	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.	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.	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.	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
Change in opioid misuse	Alcohol Smoking and Substance Involvement Screening Test severity score (prescription opioids/heroin, scores range 0-27 per subscale, higher score indicates worse outcomes)	3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in days of opioid misuse	Addiction Severity Index (modified; score ranges from 0-30, higher score indicates worse outcomes)	3, 6, and 12 months
Change in overdose risk behaviors	Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes)	3, 6, and 12 months
Change in other drug and alcohol use	Substance use index (based on frequency measures, higher scores indicate worse outcome)	3, 6, and 12 months
Change in substance use consequences	Adapted alcohol, cannabis, and/or opioid-related consequences (total, higher score indicates worse outcomes)	3, 6, and 12 months
Change in impaired driving	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

• 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

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 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): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: opioid misuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• 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