臨床研究法に基づく特定臨床研究である本臨床試験の研究計画書を作成し、2023年8月31日に慶應義塾臨床研究審査委員会による承認を受け、同年9月21日に関東信越厚生局に届け出た。また、Usona Instituteよりシロシビンの非臨床試験、体内動態試験、安全性試験などのデータを記載したInvestigator’s brochureを入手した。本臨床試験の実施に関して、厚生労働省、東京都の担当部署、麻薬輸入業者は既に連携済みであり、2024年3月試験薬の輸入が完了する見込みである。本試験を安全に実施するため、本研究グループとは利害関係のない精神科医、看護師、心理士、人文学者、当事者、報道関係者からなるアドバイザリーボードを設置した。
本試験で精神展開剤による神秘体験を評価するための評価尺度（Mystical Experience Questionnaire、Ego Dissolution Index）は、英語版開発者と連携し、日本語版を作成し、学術誌に発表した（Neuropsychopharmacol Rep 2024; Neuropsychopharmacol Rep 2024）。同様に英語版開発者と連携し、Challenging Experience Questionnaire日本語版を作成し、学術誌に投稿準備中である。
また、シロシビンを含む精神展開剤の臨床試験を複数実施しているDavid Nutt教授（インペリアル・カレッジ・ロンドン）の指導を受け、試験薬投与の手順を確定した。
A research protocol for this clinical study, a specific clinical rial under the Clinical Research Act, was prepared, approved by the Keio University Clinical Research Review Committee on August 31, 2023, and submitted to the Kanto Shinetsu Health and Welfare Bureau on September 21, 2023. In addition, we obtained an Investigator's brochure from Usona Institute, which contains data on non-clinical studies, pharmacokinetic studies, and safety studies of psilocybin. The Ministry of Health, Labour and Welfare (MHLW), the Tokyo Metropolitan Government (TMG), and the drug importer have already collaborated on the implementation of this clinical trial, and the import of the test drug is expected to be completed in March 2024. In order to ensure the safe conduct of the study, an advisory board consisting of psychiatrists, nurses, psychologists, humanists, interested parties, and members of the press who have no vested interest in this study group has been established.
The rating scales used to assess mystical experience with psychedelic drugs in this study (Mystical Experience Questionnaire and Ego Dissolution Index) were developed in collaboration with the developers of the English version, and a Japanese version was created and published in a journal (Neuropsychopharmacol Rep 2024; Neuropsychopharmacol Rep 2024). Similarly, in collaboration with the developers of the English version, a Japanese version of the Challenging Experience Questionnaire was created and is being prepared for submission to an academic journal.
In addition, under the guidance of Professor David Nutt (Imperial College London), who has conducted several clinical trials of psychoactive agents including psilocybin, we have finalized the study drug administration procedures.