Safety and efficacy of high dose buprenorphine initiation in fentanyl positive emergency department patients.

Background: The safety and efficacy of high dose buprenorphine (BUP) induction in fentanyl positive emergency department patients (high dose BUP) study includes two clinical trials funded through the helping to end addiction long-term Methods: Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP initiation (32 mg) and continuation (24 mg) as compared to standard dose BUP initiation (12 mg) and continuation (16 mg). Trial 2 is a small pilot multicenter randomized, double blind clinical trial in 80 participants, randomized 1:1, that will provide preliminary efficacy data. The primary outcome measure for trial 1 is the frequency of dose treatment-emergent adverse events (TEAEs) grade 3 (per common terminology criteria for adverse events v5.0 (CTCAE v5.0)), including but not limited to bradypnea <8, oxygen saturation<88% on room air and/or rescue naloxone administration. The primary outcome measure for trial 2 is the proportion of participants engaged in comprehensive addiction treatment at 7-days post ED initiation. Conclusions: The results of these trials will provide crucial data on the safety, feasibility and efficacy of high-dose ED BUP initiation and continuation in fentanyl positive ED patients and inform incorporation of high-dose BUP initiation into ED care for patients with OUD. Trial registration: ClinicalTrials.gov ID: NCT05589181.