High Dose BUP Induction in the Emergency Department (ED)
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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 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.