An interventional study of Refined EMBED CDS and Provider alert that nurse completed COWS in Opioid Abuse (Disorder) and Clinical Decision Support, sponsored by Yale University. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
Among 106 studies in Opioid-Related Disorders by Yale University — 20 open to participants now, 24 under way, 1 of them phase 3. Opioid-Related Disorders · Yale University.
Among the 106 studies in Opioid-Related Disorders by Yale University, this one is the 42nd largest by planned enrollment of the 94 interventional ones that give a count, is one of 8 that started in 2026, is one of 44 with no phase, reaches primary completion later than 6 of the 23 other live ones, and was the 104th registered.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →20 of the 106 studies in Opioid-Related Disorders by Yale University are open now, in 4 countries. Recruiting first, the newest first:
Yale University · Sites in United States
Yale University · Sites in United States
Yale University · Sites in United States
Yale University · Sites in United States
Yale University · Sites in United States
By country, each count listing its studies:
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
106 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 26 · Phase 3 7 · Phase 4 9
First in 1988; this study’s year is marked. 8 started in 2026.
This study's planned enrollment of 100 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 62 across the 94 interventional studies, 108 across the 11 observational. Of the 75 that completed or were terminated, 26 (35%) have results posted.
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Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
10 of the studies in Opioid-Related Disorders by Yale University that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06494904Phase 3Yale UniversityStandard Versus High Dose ED-Initiated Buprenorphine Induction | 2027-09 |
| NCT05333341Yale UniversityPain Care at Home to Amplify Function (Pain CHAMP) | 2026-11-30 |
| NCT01730781Yale UniversityImaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning | 2026-12 |
| NCT06160284Yale UniversityExploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD) | 2027-01 |
| NCT06207162Yale UniversityLongitudinal Neural Fingerprinting of Opioid-use Trajectories | 2027-01 |
Among the 106 studies in Opioid-Related Disorders by Yale University, from their registry updates:
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This study is stage 2, round 3 of a larger study which refines and optimizes the EMBED clinical decision support (CDS) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. See NCT03658642
This study is stage 3, rapid response testing (RRT), of the optimization phase of a larger study which refines and optimizes the EMBED* clinical decision support (CDS); see NCT03658642 to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. Investigators will use a Multiphase Optimization Strategy (MOST) framework with preparation, optimization, and confirmatory phases.
In stage 2, optimization phase, investigators will conduct serial rapid-cycle randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment through identification of specific targets for improvement via application of novel CDS outcome measures with the goal of improving CDS usability.
Five rounds of A-B testing are expected. The more successful condition will be tested in the subsequent round against a novel test condition. In this second round investigators will randomize an alert to providers to order a consult with addiction counselors. Future rounds will be planned, with arms and interventions added, as the project progresses in order to build on insights gained in each round.
Phase 3, the evaluation phase will consist of a randomized trial of the optimized package compared to the original EMBED and the evaluation phase in which investigators will compare the efficacy of the optimized, multicomponent CDS package to the original EMBED CDS on ED-initiation of buprenorphine rates in patients with OUD in a randomized trial.
*EMBED is a user centered, clinician facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community
This study does not have open enrollment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
EMBED CDS refined based on previous results
Other: Refined EMBED CDS · Other: Provider alert that nurse completed COWS
Alert to provider in Epic that the nurse completed COWS
Other: Provider alert that nurse completed COWS
Refined EMBED CDS
Provider alert that nurse completed COWS
Proportion of encounters with Buprenorphine initiation in the ED
Proportion of eligible encounters with buprenorphine administered in the Emergency Department (ED) and/or prescribed buprenorphine on discharge from the ED. Obtained from EHR data.
Time frame: Trial round start to end up to 3 months
Proportion of eligible encounters with CDS engagement
Proportion of eligible encounters in which any portion of the EMBED workflow was documented or completed.
Time frame: Trial round start to end up to 3 months
Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally
Proportion of eligible encounters in which buprenorphine order is placed through EMBED (i.e., using EMBED order set).
Time frame: Trial round start to end up to 3 months
Time spent on EMBED
Time (in seconds) spent on EMBED overall and by component.
Time frame: Trial round start to end up to 3 months
Task Completion: Proportion of encounters with OUD diagnosis was recorded
Proportion of encounters where EMBED was opened in which the OUD diagnosis was recorded.
Time frame: Trial round start to end up to 3 months
Task completion: Buprenorphine order or prescription placed
Proportion of encounters where EMBED was opened in which a buprenorphine order or prescription was placed.
Time frame: Trial round start to end up to 3 months
Plan to share: Yes — De-identified data related to EHR use measurements in various levels of aggregation. e.g., time spent on the CDS or threshold outcomes such as dismissal of the CDS without action under a specific amount of time or the time spent on CDS that exceeds what was expected based on the patient's clinical opioid withdrawal (COWS) score, time in the ED, or level of acuity, patient acuity, chief complaints or diagnoses, clinician, interruptions (such as orders started but not finished), task switching, seasonality, and variation in shift timing (such as nights and weekends). Data shared will include variables relating to patient demographics, medical history, prescription information, clinician facing clinical decision support (CDS) firing and clinician action information, and clinician prescribing decisions and historical prescribing.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: De-identified data will be shared with NAHDAP as soon as possible upon completion of quality control procedures, analysis, and at the time of associated publication or end of performance period. Data will be released by NAHDAP at the time of receipt and will be available indefinitely.
Access criteria: De-identified data sets used for analysis will be submitted to NAHDAP through the NIH HEAL Initiative and will be available for public use according to NAHDAP data sharing policies and restrictions set by our DUA with NAHDAP and our IRB. All data submissions to NAHDAP undergo confidentiality review to protect respondents' data from being re-identified. Portions of the ADAPT intervention will be built for national distribution on the Epic EHR platform. Distribution of code that is proprietary to Epic may limit distribution of certain portions of software or code. In this situation, investigators will provide dashboards and visualizations of workflow diagrams as appropriate to disclose interface and workflow concepts to the broader scientific community These portions of the data will also be subject to restricted use access outside of organizations using Epic.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2027, 6 months after the start.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 6 months is below that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Aug 2026, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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