- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527871
Emergency Department-Substance Use Screening, Motivational Interviewing and Active Referral Targeting Substance Use Disorder and Overdose Prevention (ED-SMART)
May 19, 2026 updated by: BrownLab, Purdue University
ED-SMART: Emergency Department-Substance Use Screening, Motivational Interviewing and Active Referral Targeting Substance Use Disorder and Overdose Prevention
The purpose of this research study is to learn if an emergency department screening and telehealth intervention reduces substance use among individuals receiving emergency department treatment at The Ohio State University Wexner Medical Center.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
650
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: Jennifer L Brown, PhD
- Phone Number: 866-818-2620
- Email: jenniferbrown@purdue.edu
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:
- Adult at least 18 years of age
- Capacity and willingness to participate (including reliable phone or internet access for counseling session)
- Lower or Moderate Risk score on one or more substance use types on National Institute on Drug Abuse (NIDA)-Modified Alcohol, Smoking, and Substance Use Involvement Test (ASSIST). Participants may also endorse alcohol use in conjunction with substance use as indicated by an Alcohol Use Disorder Identification Test-Concise (AUDIT-C) score of Moderate Risk.
Exclusion Criteria:
- A priori participant request for participation
- Previously enrolled in this or other study of substance use disorder prevention
- Language other than English
- Expected/actual ED disposition of hospitalization or non-independent status
- Prisoner at time of enrollment
- Known to be pregnant at time of enrollment
- Past substance use disorder or substance use treatment
- High risk score for one or more substances on the NIDA-Modified ASSIST or problematic alcohol use alone
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ED-SMART intervention
The ED-SMART intervention includes: (i) a brief (approximately 15 minutes) counseling session in the emergency department and (ii) five, monthly brief counseling sessions (approximately 15 to 30 minutes) delivered by telehealth.
These sessions will focus on creating individualized strategies to help participants reach their alcohol and substance use reduction goals.
|
The ED-SMART intervention will include: (i) a brief (approximately 15 minutes) counseling session in the emergency department and (ii) five, monthly brief counseling sessions (approximately 15 to 30 minutes) delivered by telehealth.
These sessions will focus on creating individualized strategies to help participants reach their alcohol and substance use reduction goals
|
|
Placebo Comparator: Substance use information
The substance use information condition will receive printed health information covering information about substance use (e.g., definitions, hazards, potential for addiction, injury, and other consequences).
Staff will also discuss ways to utilize primary care or establish care with a primary care provider to provide ongoing follow-up.
|
The substance use information condition will receive printed health information covering information about substance use (e.g., definitions, hazards, potential for addiction, injury, and other consequences).
Research staff will also discuss ways to utilize primary care or establish care with a primary care provider to provide ongoing follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported substance use
Time Frame: From baseline to the sixth month follow-up assessment
|
Self-reported substance use frequency
|
From baseline to the sixth month follow-up assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported substance use quantity
Time Frame: From baseline to the six month follow-up
|
Self-reported substance use quantity for each substance
|
From baseline to the six month follow-up
|
|
Incidence of positive substance use disorder screen
Time Frame: From baseline to the six month follow-up
|
Incidence of positive substance use disorder screen as measured by the NIDA Modified ASSIST or AUDIT
|
From baseline to the six month follow-up
|
|
Toxicology assays for substance use
Time Frame: From baseline to the six month follow-up assessment
|
Proportion with positive toxicology assay for substance use
|
From baseline to the six month follow-up assessment
|
|
Self-reported healthcare utilization
Time Frame: Baseline to the six month follow-up assessment
|
Self-reported healthcare utilization
|
Baseline to the six month follow-up assessment
|
|
Fatal and non-fatal overdose
Time Frame: Baseline to the six month follow-up assessment
|
Frequency of fatal and non-fatal overdose
|
Baseline to the six month follow-up assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer L. Brown, PhD, Purdue University
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)
June 1, 2026
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2029
Study Registration Dates
First Submitted
April 7, 2026
First Submitted That Met QC Criteria
April 7, 2026
First Posted (Actual)
April 14, 2026
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 19, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY2025-00000054
- U01CE003825 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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