Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial.

"Declarations Ethics approval and consent to participateThe project is approved by the Hospital Ethics Committee of the Brugmann University Hospital (reference number: CE 2023/09). Consent to participate must be obtained before the screening procedure can begin. Prior to signing the informed consent form, all potential participants will be provided with comprehensive oral and written information about the trial, including potential risks associated with the investigational medicinal product. Close family members will have the possibility to meet one of the investigators to receive information about the trial and ask questions. Consent for publicationNot applicable. Competing interestsThe authors declare no competing interests. Competing interests The authors declare no competing interests."

"Funding This project is funded by the Belgian National Funds for Scientific Research, the Brugmann Foundation, and the Iris Foundation. These grant allocations involved peer review by scientific commissions and covered human resources and operating costs. The pharmaceutical psilocybin will be manufactured by Psilo Scientific Ltd. (Wholly Owned Subsidiary Of Filament Health Corp.). Labeling and release will be performed by Cefea Sp. z o.o. sp. k. These funding sources had no role in the design of the study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results."

"Trial registration EudraCT 2022-002369-14 and NCT06160232."