Opioid Use DisorderNCT07278518
Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine
A study testing Patient Decision Aid for Opioid Use Disorder in people with Opioid Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Patient Decision Aid for Opioid Use Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 13 Feb 2027
- 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
- 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
Who cannot join
- Prisoners
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, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Lindsey Jennings, MD, 843-792-2300, jennil@musc.edu
About this study
Official title: 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).
- Conditions
- Opioid Use Disorder
- Being tested
- Patient Decision Aid for Opioid Use Disorder
- Keywords
- buprenorphine, patient decision aid, emergency department
- Medical subject headings
- Opioid-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Decision Aid for Opioid Use DisorderBehavioural
This will include information structured for patients about buprenorphine as a treatment options in the emergency department.
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Aid | Experimental | This arm will receive the patient decision aid Receives: Behavioral: Patient Decision Aid for Opioid Use Disorder |
| Treatment as Usual | No intervention | This will be treatment as usual without the patient decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
Measured: Day 1
Secondary outcomes (4)
Knowledge about MOUD
This is a multiple choice knowledge quiz
Measured: pre and post intervention on day 1, and at 7 days
Treatment selection
Measured: Day 1
Decisional Conflict Scale
Measured: Day 1
Receipt of buprenorphine
Measured: Day 1, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start13 Aug 2026
- Primary completion13 Feb 2027 (estimated)
- Study completion13 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lindsey Jennings, Medical University of South Carolina
- Investigators
- Lindsey Jennings, MD, MPH, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278518
- Sponsor's protocol ID
- Pro00145434
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared via the NIDA data repository in accordance with NIH Data Management and Sharing Policy.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTN-0156: Pilot Development and Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine
- ClinicalTrials.gov ID
- NCT07278518
- Acronym / sponsor ID
- Pro00145434
- Conditions
- Opioid Use Disorder
- Keywords
- buprenorphine, patient decision aid, emergency department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 13 Feb 2027 (estimated)
- First posted
- 12 Dec 2025 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Aid | Experimental | Behavioral: Patient Decision Aid for Opioid Use DisorderThis arm will receive the patient decision aid |
| Treatment as Usual | No intervention | –This will be treatment as usual without the patient decision aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Prisoners
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 |
|---|---|---|
| Patient Decision Aid for Opioid Use DisorderThis will include information structured for patients about buprenorphine as a treatment options in the emergency department. | Behavioural | Patient Decision Aid |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: Day 1
4 secondary outcomes
Knowledge about MOUD
Time frame: pre and post intervention on day 1, and at 7 days
Treatment selection
Time frame: Day 1
Decisional Conflict Scale
Time frame: Day 1
Receipt of buprenorphine
Time frame: Day 1, 7
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 24 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared via the NIDA data repository in accordance with NIH Data Management and Sharing Policy.
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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.
Lindsey Jennings, MD, MPH principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Decision Aid for Opioid Use Disorder in people with Opioid Use Disorder, run by Medical University of South Carolina 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Aug 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. 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?
Contact Lindsey Jennings, MD, MPH ((843) 876-8023, jennil@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: Day 1). 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 24 Aug 2026.