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RECRUITING
NCT05589181
PHASE3

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

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

Summary

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.

Official title: Safety and Efficacy of High Dose Buprenorphine Induction in Fentanyl Positive Emergency Department Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2023-04-06

Completion Date

2026-12-31

Last Updated

2025-10-23

Healthy Volunteers

No

Interventions

DRUG

High Dose Buprenorphine

32mg of BUP split as 16mg at 0 minutes and 16mg at 30-60 min as an induction dose

DRUG

Standard Buprenorphine Dose

12mg of buprenorphine (BUP) split as 8mg at 0 minutes and 4mg at time 30-60 min as an induction dose

Locations (1)

Rutgers University Hospital

Newark, New Jersey, United States