Substance Use (Drugs, Alcohol)ED-SMARTNCT07527871
Emergency Department-Substance Use Screening, Motivational Interviewing and Active Referral Targeting Substance Use Disorder and Overdose Prevention
A study testing ED-SMART intervention and Substance use information in people with Substance Use (Drugs, Alcohol), run by Purdue University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use (Drugs, Alcohol)
- What is being tested?
- ED-SMART intervention and Substance use information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43201
About this study
Official title: 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.
- Conditions
- Substance Use (Drugs, Alcohol)
- Being tested
- ED-SMART intervention, Substance use information
- Keywords
- substance use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-SMART interventionBehavioural
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
Substance use informationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ED-SMART intervention | Experimental | 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. Receives: Behavioral: ED-SMART intervention |
| Substance use information | Placebo comparator | 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. Receives: Behavioral: Substance use information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported substance use
Self-reported substance use frequency
Measured: From baseline to the sixth month follow-up assessment
Secondary outcomes (5)
Self-reported substance use quantity
Self-reported substance use quantity for each substance
Measured: From baseline to the six month follow-up
Incidence of positive substance use disorder screen
Incidence of positive substance use disorder screen as measured by the NIDA Modified ASSIST or AUDIT
Measured: From baseline to the six month follow-up
Toxicology assays for substance use
Proportion with positive toxicology assay for substance use
Measured: From baseline to the six month follow-up assessment
Self-reported healthcare utilization
Self-reported healthcare utilization
Measured: Baseline to the six month follow-up assessment
Fatal and non-fatal overdose
Frequency of fatal and non-fatal overdose
Measured: Baseline to the six month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start17 Jun 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use (Drugs, Alcohol)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, BrownLab, Purdue University
- Investigators
- Jennifer L. Brown, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527871
- Sponsor's protocol ID
- STUDY2025-00000054
- Other IDs
- U01CE003825
- Acronym
- ED-SMART
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED-SMART: Emergency Department-Substance Use Screening, Motivational Interviewing and Active Referral Targeting Substance Use Disorder and Overdose Prevention
- ClinicalTrials.gov ID
- NCT07527871
- Acronym / sponsor ID
- ED-SMART / STUDY2025-00000054
- Conditions
- Substance Use (Drugs, Alcohol)
- Keywords
- substance use
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED-SMART intervention | Experimental | Behavioral: ED-SMART interventionThe 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. |
| Substance use information | Placebo comparator | Behavioral: Substance use informationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED-SMART interventionThe 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 | Behavioural | ED-SMART intervention |
| Substance use informationThe 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. | Behavioural | Substance use information |
Primary outcome
Self-reported substance use
Time frame: From baseline to the sixth month follow-up assessment
Self-reported substance use frequency
5 secondary outcomes
Self-reported substance use quantity
Time frame: 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
Toxicology assays for substance use
Time frame: From baseline to the six month follow-up assessment
Self-reported healthcare utilization
Time frame: Baseline to the six month follow-up assessment
Fatal and non-fatal overdose
Time frame: Baseline to the six month follow-up assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer L. Brown, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED-SMART intervention and Substance use information in people with Substance Use (Drugs, Alcohol), run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported substance use (time frame: From baseline to the sixth month follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.