Trial · NCT05589181
High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
NCT05589181, Phase 3, Recruiting, Rutgers, The State University of New Jersey
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED). Trials, record NCT05589181. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05589181
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
- NCT number
- NCT05589181
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 140 participants, estimated
- Lead sponsor
- Rutgers, The State University of New Jersey
- Conditions
- Opioid Use Disorder
- Interventions
- High Dose Buprenorphine, Standard Buprenorphine Dose
- First posted
- 2022-10-21
- Last updated
- 2026-07-30
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction | 7 days post-ED visit | The proportion of participants engaged in comprehensive addiction treatment at 7 days post-ED induction as verified by participant and the addiction treatment program. |
| Secondary | Percentage of days with opioid abstinence (Trial 1) | at day 7 | Participants' percentage of days with opioid abstinence (defined as negative urine drug screen (UDS)) at day 7 (Trial 1) |
| Secondary | Percentage of days with opioid use (Trial 1) | 7 days post-ED | Participants' percentage of days with opioid use at Time-Line Follow Back (TLFB) over 7 days post induction (inclusive) (Trial 1) |
| Secondary | Percentage of days with opioid use (Trial 2) | 30 days post-ED | Participants' percentage of days with opioid use at Time-Line Follow Back (TLFB) over 30 days post induction (inclusive) (Trial 2) |
| Secondary | Daily assessment of opioid use (Trial 1) | Days 1-7 after enrollment | Participants' daily assessment of opioid use out of days over a 7-day period (Trial 1) |
| Secondary | Change in number of times opioids used (Trial 1) | induction through 7 days | Change in participants' number of times opioids were per day used from induction through 7 days follow-up assessment (Trial 1) |
| Secondary | Change in number of times opioids used (Trial 2) | Baseline and follow-up assessment day 7 | Change in participants' number of times opioids were used from baseline to follow-up assessment day 7 (Trial 2) |
| Secondary | Change in number of times opioids used (Trial 2) | Baseline and follow-up assessment day 30 | Change in participants' number of times opioids were used from baseline to follow-up assessment day 30 (Trial 2) |
| Secondary | Proportion of participants with persistent nausea/vomiting during induction | at 240 minutes | Proportion of participants with persistent nausea/vomiting during the induction visit requiring treatment. |
| Secondary | Proportion of participants with a Pasero Opioid-induced Sedation Scale (POSS) score of 3 or higher | at 240 minutes | Proportion of participants with a POSS score of 3 or higher at the conclusion of the induction visit 4-hour observation period. Higher score indicates more severe sedation. S=sleep, easy to arouse 1. awake/alert 2. slight drowsy/easy aroused 3. Frequently drowsy, arousable, drifts off to sleep during conversation 4. Somnolent, minimal or no response to verbal and physical stimulation |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41743896 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG3DA056891 | Safety and Efficacy of High Dose Buprenorphine Induction in Fentanyl Positive Emergency Department Patients | MANINI, ALEX FRANCIS; COWAN, ETHAN ADRIAN | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL INSTITUTE ON DRUG ABUSE | 2022 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05589181
GET https://conductscience.org/api/trials/v1/NCT05589181/registered