Later this week, MAPS will submit an application to FDA this week for a new study evaluating psilocybin-assisted psychotherapy for subjects with end-of-life anxiety secondary to advanced-stage melanoma. The study will take place in the US and will evaluate nine subjects with anxiety secondary to advanced-stage melanoma. MAPS has been working with the researchers on protocol development for over one year. The protocol was submitted last month to FDA and to an IRB, with the review currently in process. We will be able to post the protocol on the MAPS Website and disclose the names and institutional affiliations of the researchers after the study receives IRB and FDA approval. The researchers for this study have generously offered to volunteer their time, which will reduce overall costs significantly. The estimated budget for this study is $50,000, all of which remains to be raised.
