Clinical trial NCT04550715: Prevention Interventions for Opioid Misuse
Official title: Optimized Interventions to Prevent Opioid Use Disorder Among Adolescents and Young Adults in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: opioid misuse
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-09-16
Enrollment: 1155
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in opioid misuse
timeFrame: 3, 6, and 12 months
Secondary outcomes:
measure: Change in days of opioid misuse
timeFrame: 3, 6, and 12 months
measure: Change in overdose risk behaviors
timeFrame: 3, 6, and 12 months
measure: Change in other drug and alcohol use
timeFrame: 3, 6, and 12 months
measure: Change in substance use consequences
timeFrame: 3, 6, and 12 months
measure: Change in impaired driving
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Maureen Walton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Erin Bonar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.