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Prevention Interventions for Opioid Misuse

Primary Purpose

Opioid Use

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brief intervention (BI)

Portal

Enhanced Usual Care (EUC)

About this trial

This is an interventional prevention trial for Opioid Use focused on measuring opioid misuse

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Brief intervention (BI) then Portal

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

Enhanced Usual Care (EUC) then Portal

Enhanced Usual Care (EUC) then EUC

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in days of opioid misuse

Addiction Severity Index (modified; score ranges from 0-30, higher score indicates worse outcomes)

Change in overdose risk behaviors

Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes)

Change in other drug and alcohol use

Substance use index (based on frequency measures, higher scores indicate worse outcome)

Change in substance use consequences

Adapted alcohol, cannabis, and/or opioid-related consequences (total, higher score indicates worse outcomes)

Change in impaired driving

Adapted items from Young Adult Driving Questionnaire (5 items; score ranges from 0-30; higher score indicates worse outcome)

Full Information

NCT ID

NCT04550715

First Posted

August 25, 2020

Last Updated

July 10, 2023

Sponsor

University of Michigan

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT04550715

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 4, 2021 (Actual)

Primary Completion Date

March 30, 2025 (Anticipated)

Study Completion Date

March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Use

Keywords

opioid misuse

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

1280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Brief intervention (BI) then Portal

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

Enhanced Usual Care (EUC) then Portal

Arm Type

Experimental

Arm Description

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

Arm Title

Enhanced Usual Care (EUC) then EUC

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Brief intervention (BI)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Portal

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Usual Care (EUC)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in opioid misuse

Description

Alcohol Smoking and Substance Involvement Screening Test severity score (prescription opioids/heroin, scores range 0-27 per subscale, higher score indicates worse outcomes)

Time Frame

3, 6, and 12 months

Secondary Outcome Measure Information:

Title

Change in days of opioid misuse

Description

Addiction Severity Index (modified; score ranges from 0-30, higher score indicates worse outcomes)

Time Frame

3, 6, and 12 months

Title

Change in overdose risk behaviors

Description

Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes)

Time Frame

3, 6, and 12 months

Title

Change in other drug and alcohol use

Description

Substance use index (based on frequency measures, higher scores indicate worse outcome)

Time Frame

3, 6, and 12 months

Title

Change in substance use consequences

Description

Adapted alcohol, cannabis, and/or opioid-related consequences (total, higher score indicates worse outcomes)

Time Frame

3, 6, and 12 months

Title

Change in impaired driving

Description

Adapted items from Young Adult Driving Questionnaire (5 items; score ranges from 0-30; higher score indicates worse outcome)

Time Frame

3, 6, and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meredith Kotov

Phone

734-232-0361

mphilyaw@med.umich.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Carrie Bourque

csmolens@med.umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maureen Walton, PhD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Erin Bonar, PhD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34352386

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.

Results Reference

derived

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Prevention Interventions for Opioid Misuse

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