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

This study is exploring the safety and psychological effects of two plant-based preparations containing DMT (dimethyltryptamine) and harmala alkaloids — active ingredients found in a traditional Amazonian brew known as ayahuasca. The study is designed to compare two different oral formulations in a clinical, supervised setting to determine which one is more suitable for use in future trials for people with depression. Healthy volunteers who have previously taken one of these preparations participate in two separate sessions, each involving a different formulation. Researchers measure psychological effects (such as the intensity and nature of the psychedelic experience), vital signs, and side effects throughout the day, and participants are followed up afterward. You may be eligible if you are aged 25–70, in good physical and mental health, have previously used a DMT-harmaloid plant preparation, weigh between 50–90 kg, and have a BMI of 18–32. You are not eligible if you have a personal or close family history of psychosis, are currently taking antidepressants or any medications that interact with MAO inhibitors, or have a substance use disorder. Participation requires fasting from midnight and having someone available to take you home after each session.