Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine

March 9, 2026 updated by: Lindsey Jennings, Medical University of South Carolina

CTN-0156: Pilot Development and Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lindsey Jennings, MD, MPH
  • Phone Number: (843) 876-8023
  • Email: jennil@musc.edu

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Decision Aid
This arm will receive the patient decision aid
Behavioral: Patient Decision Aid for Opioid Use Disorder
This will include information structured for patients about buprenorphine as a treatment options in the emergency department.
No Intervention: Treatment as Usual
This will be treatment as usual without the patient decision aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acceptability of Intervention Measure (AIM)
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about MOUD
Time Frame: pre and post intervention on day 1, and at 7 days
This is a multiple choice knowledge quiz
pre and post intervention on day 1, and at 7 days
Treatment selection
Time Frame: Day 1
Day 1
Decisional Conflict Scale
Time Frame: Day 1
Day 1
Receipt of buprenorphine
Time Frame: Day 1, 7
Day 1, 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Lindsey Jennings, MD, MPH, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 19, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00145434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid Use Disorder

Clinical Trials on Patient Decision Aid for Opioid Use Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe