NCT07278518

Brief Summary

This study aims to develop and pilot test a patient decision aid (PtDA) for emergency department (ED)-initiated buprenorphine treatment for opioid use disorder (OUD). The PtDA will be evaluated for acceptability, impact on patient knowledge, decisional conflict, and buprenorphine uptake compared to treatment as usual (TAU).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 19, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

December 3, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

buprenorphinepatient decision aidemergency department

Outcome Measures

Primary Outcomes (1)

  • Acceptability of Intervention Measure (AIM)

    Day 1

Secondary Outcomes (4)

  • Knowledge about MOUD

    pre and post intervention on day 1, and at 7 days

  • Treatment selection

    Day 1

  • Decisional Conflict Scale

    Day 1

  • Receipt of buprenorphine

    Day 1, 7

Study Arms (2)

Patient Decision Aid

EXPERIMENTAL

This arm will receive the patient decision aid

Behavioral: Patient Decision Aid for Opioid Use Disorder

Treatment as Usual

NO INTERVENTION

This will be treatment as usual without the patient decision aid

Interventions

This will include information structured for patients about buprenorphine as a treatment options in the emergency department.

Patient Decision Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18
  • DSM-5 criteria for moderate-to-severe OUD
  • Speaks and reads English
  • Not currently prescribed MOUD
  • Post-ED discharge patients with access to video/email

You may not qualify if:

  • \- Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related DisordersEmergencies

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lindsey Jennings, MD, MPH

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Jennings, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor-Faculty

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 12, 2025

Study Start (Estimated)

May 19, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified data will be shared via the NIDA data repository in accordance with NIH Data Management and Sharing Policy.

Shared Documents
STUDY PROTOCOL

Locations