The first phase 2a clinical trial with BPL-003, a novel intranasal benzoate salt formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), was conducted as an open-label proof-of-concept study for the treatment of moderate to severe alcohol use disorder. The aim of this study was to assess safety and tolerability of BPL-003. Twelve participants received a single dose of 10 mg intranasally via a dry powder intranasal spray device with 3 pre-dose preparation sessions and 3 post-dose integration sessions over 12 weeks of follow-up. Reduction in alcohol use was reported, with abstinent days increasing from 33.2% at baseline to 80.8% at week 12. Reductions in craving, and improvement in quality-of-life measurements were also reported; however, all efficacy outcomes were exploratory, and confirmation will be needed in larger controlled clinical trials. Mild to moderate adverse events were reported as expected in most patients on the day of dosing and included administration site pain (30%), transient blood pressure elevation (30%), nightmares (15%), and nausea (15%). Two participants reported short flashbacks days after dosing, with one reported as seeing lights and experiencing “non-distressing” physical sensations; participants were aware of their surroundings during the events. Overall, BPL-003 was safe, well tolerated, and shows promise as a new treatment option for alcohol use disorder. Marsden J, Kelleher M, Dunbar F, et al. 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial. Addiction. 2025 Dec 10. https://doi.org/10.1111/add.70260 Phase 1 BPL-003 trial: 10.1038/s41598-025-22620-z