Shastry, SLove, JLoo, GManini, AFO’Brien-Lambert, CWang, LCowan, E.2025-08-132025-08-132025-03Shastry 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 . International Journal of Clinical Trials. 2025 Mar; 12(1): 11-202349-32402349-3259https://imsear.searo.who.int/handle/123456789/250219Background: 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-termSM initiative. The study tests whether initiation and continuation of BUP at higher doses and over a shorter time period than currently recommended is safe, tolerable and effective. 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.BUPFentanylPrecipitated withdrawalJournal ArticleIndiaDepartment of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, USADepartment of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, USADepartment of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, USA; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USADepartment of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, USA; Division of Medical Toxicology, Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, Elmhurst Hospital Center, New York, USADepartment of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, USARespectful and Equitable Access to Comprehensive Healthcare (REACH) Program, Division of General Internal Medicine, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, USADepartment of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, USA