An open label study to evaluate the safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations in healthy volunteers

Two orally administered DMT–harmala formulations will be tested in healthy volunteers in separate single-dose sessions with a two-week washout; an interim assessment determines formulation and dose escalation.

Safety and tolerability will be assessed via AEs/SAEs, vital signs (BP, ECG, pulse) and the Integration Difficulties Scale; mental health effects via DASS-21 acutely and at follow-ups.