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

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.

Timeline

Start

2023-04-06

Primary completion

2026-09-01

Completion

2026-12-31

Publications

• Shastry S, Love J, Loo G, Manini AF, O'Brien-Lambert C, Wang L, Cowan E. Safety and efficacy of high dose buprenorphine initiation in fentanyl positive emergency department patients. Int J Clin Trials. 2025 Jan-Mar;12(1):11-20. doi: 10.18203/2349-3259.ijct20250130. Epub 2025 Jan 28.

Drugs

Indications