High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
Safety and Efficacy of High Dose Buprenorphine Induction in Fentanyl Positive Emergency Department Patients
Rutgers, The State University of New Jersey
140 participants
Apr 6, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
32mg of BUP split as 16mg at 0 minutes and 16mg at 30-60 min as an induction dose
12mg of buprenorphine (BUP) split as 8mg at 0 minutes and 4mg at time 30-60 min as an induction dose
Locations(1)
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NCT05589181