This Phase I interventional trial (n=16), known as HaD-PET, aims to investigate the acute cerebrometabolic effects of harmine/DMT (ayahuasca/pharmahuasca) in healthy volunteers using quantitative FDG-PET.
The study, sponsored by Insel Gruppe AG, University Hospital Bern, Switzerland, began on January 22, 2024. Participants must be between 25-45 years old, proficient in German, and willing to comply with study requirements. They should also have previous experience with psychedelics but not within the past three months. Exclusion criteria include significant adverse responses to psychedelic drugs, certain medical conditions, and recent participation in other pharmaceutical studies.
The study involves administering either DMT and harmine or a placebo to participants and measuring changes in cerebral metabolic rate for glucose (CMRglc) before and after treatment using PET scans.
Secondary outcome measures include assessing blood glucose levels, plasma concentrations of DMT, harmine, and their metabolites, as well as subjective effects, blood pressure, heart rate, and psychological questionnaires related to consciousness and emotional experiences.
The estimated study completion date is April 2025.
Trial Details
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