Prevention Interventions for Opioid Misuse

University of Michigan

Status: Completed

Conditions: Opioid Use

Treatments: Behavioral: Enhanced Usual Care (EUC); Behavioral: Portal; Behavioral: Brief intervention (BI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04550715

UG3DA050173 (U.S. NIH Grant/Contract)

HUM00177625

Details and patient eligibility

About

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.

Enrollment: 1,155 patients

Sex: All

Ages: 16 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,155 participants in 4 patient groups

Brief intervention (BI) then Portal

Experimental group

Description:

The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.

Treatment:

Behavioral: Brief intervention (BI)

Behavioral: Portal

Brief intervention (BI) then Enhanced Usual Care (EUC)

Experimental group

Description:

The BI will be delivered at intake and EUC will be added 4 weeks later.

Treatment:

Behavioral: Brief intervention (BI)

Behavioral: Enhanced Usual Care (EUC)

Enhanced Usual Care (EUC) then Portal

Experimental group

Description:

EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.

Treatment:

Behavioral: Portal

Behavioral: Enhanced Usual Care (EUC)

Enhanced Usual Care (EUC) then EUC

Active Comparator group

Description:

EUC will be delivered at intake and delivered again 4 weeks later.

Treatment:

Behavioral: Enhanced Usual Care (EUC)