Prevention Interventions for Opioid Misuse

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04550715
• Other study ID #: HUM00177625
• Secondary ID: UG3DA050173
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 discharge via a telehealth approach. This study will have significant impact by identifying optimal, cost-effective opioid prevention strategies to sustain outcomes among AYAs.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1155
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Opioid-Related Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in overdose risk behaviors	Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes)	3, 6, and 12 months
Secondary	Change in other drug and alcohol use	Substance use index (based on frequency measures, higher scores indicate worse outcome)	3, 6, and 12 months
Secondary	Change in substance use consequences	Adapted alcohol, cannabis, and/or opioid-related consequences (total, higher score indicates worse outcomes)	3, 6, and 12 months
Secondary	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