Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05589181 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 30, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv13
  2. Study sites: 7 to 1v12
  3. Primary completion date: Aug 2026 to Sep 1, 2026
    • Study completion date: Aug 2026 to Dec 31, 2026
    v11
  4. Lead sponsor: Icahn School of Medicine at Mount Sinai to Rutgers, The State University of New Jerseyv10
  5. Primary and study completion dates: Sep 2025 to Aug 2026
    • Study sites: 5 to 7
    • Start date: Apr 10, 2023 to Apr 6, 2023
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 4 to 5
    • Primary and study completion dates: Dec 2025 to Sep 2025
    • Eligibility criteria expanded, about 2 words
    v8
  2. Start date changed from estimate of Apr 2023 to Apr 10, 2023v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2023 to Apr 2023
    • Site details revised at 4 of 4 sites
    v6
  4. Start date: Jan 2023 to Mar 2023v5
  5. Start date: Feb 2023 to Jan 2023v4
  6. Start date: Jan 2023 to Feb 2023v3
  7. Eligibility criteria expanded, about 14 words
    • Study description expanded, about 9 words
    • Study title expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This project, involving two distinct clinical trials, tests whether induction to a higher than currently recommended buprenorphine (BUP) induction dose is safe and can improve the proportion of patients who engage in comprehensive addiction services within 7-day of induction. Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP induction (32 mg). The study involves two cohorts, (1) a 12mg cohort (standard) to determine baseline data and (2) a 32 mg (high dose) cohort. If the 32mg is intolerable, a 24 mg dose may be evaluated. Trial 2 is a small pilot multicenter randomized, double blinded, clinical trial in 80 participants (randomized 1:1) that will provide preliminary information on efficacy with the primary outcome being engagement in comprehensive addiction treatment 7-days post BUP induction. In collaboration with National Institute on Drug Abuse (NIDA), the research team have determined that there must be a minimum increase in engagement in comprehensive addiction treatment of 15% at 7-days in the high dose induction group to justify a larger future clinical trial.
Trial Details
NCT Number NCT05589181
Lead Sponsor Rutgers, The State University of New Jersey
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Opioid Use Disorder
Related terms Opioid-Related Disorders
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov