Optimized Interventions to Prevent Opioid Use Disorder Among Adolescents and Young Adults in the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 1,155
- Locations
- 1
- Primary Endpoint
- Change in opioid misuse
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 16 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Enhanced Usual Care (EUC) then Portal
EUC 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).
Intervention: Portal (Behavioral)
Enhanced Usual Care (EUC) then Portal
EUC 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).
Intervention: Enhanced Usual Care (EUC) (Behavioral)
Brief intervention (BI) then Portal
The 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).
Intervention: Brief intervention (BI) (Behavioral)
Brief intervention (BI) then Portal
The 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).
Intervention: Portal (Behavioral)
Brief intervention (BI) then Enhanced Usual Care (EUC)
The 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).
Intervention: Brief intervention (BI) (Behavioral)
Brief intervention (BI) then Enhanced Usual Care (EUC)
The 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).
Intervention: Enhanced Usual Care (EUC) (Behavioral)
Enhanced Usual Care (EUC) then EUC
EUC will be delivered at intake and delivered again 4 weeks later. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
Intervention: Enhanced Usual Care (EUC) (Behavioral)
Outcomes
Primary Outcomes
Change in opioid misuse
Time Frame: 3, 6, and 12 months
Alcohol Smoking and Substance Involvement Screening Test severity score (prescription opioids/heroin, scores range 0-27 per subscale, higher score indicates worse outcomes)
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.
Opioid Misuse Severity Score (Past 3-month)
Time Frame: 3, 6, and 12 months
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.
Secondary Outcomes
- Change in overdose risk behaviors(3, 6, and 12 months)
- Change in substance use consequences(3, 6, and 12 months)
- Change in other drug and alcohol use(3, 6, and 12 months)
- Change in impaired driving(3, 6, and 12 months)
- Overdose Risk Behaviors(3, 6, and 12 months)
- Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days)(3, 6, and 12 months)
- Other Drug and Alcohol Use Severity(3, 6, and 12 months)
- Substance Use Consequences(3, 6, and 12 months)
- Impaired Driving(3, 6, and 12 months)
- Change in days of opioid misuse(3, 6, and 12 months)
Investigators
Maureen A Walton
Professor of Psychiatry
University of Michigan