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 small open-label trial (n=8) will test the safety of two doses of the ayahuasca brew containing DMT (1.0mg to 1.4mg/kg). The trial is sponsored by Psychae and is done in collaboration with St. Vincent’s Hospital in Melbourne Australia.

Topic Healthy Subjects
Compound Ayahuasca
Country Australia
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Trial Details



Trial Number

Sponsors & Collaborators

Psychae Institute
Psychae Institute is dedicated to developing novel psychedelic therapies as registered medical treatments for mental disorders and other diseases, as well as supporting psychological wellbeing.

Papers

Acute experiences and persisting psychological effects associated with an encapsulated DMT-harmala alkaloid combination: results of a phase 1 study
This open-label study (n=9) found that an encapsulated DMT-harmala alkaloid product (pharmahuasca) produced dose-dependent mystical experiences that exceeded those reported in most previous ayahuasca studies and were associated with beneficial persisting psychological effects in healthy volunteers.

DMT and harmala alkaloids: an exploratory study of oral Acacia based formulations in healthy volunteers
This open-label exploratory study (n=9) tested three Acacia-based ayahuasca-like formulations in healthy volunteers with prior ayahuasca experience. In a cross-over design, two formulations (1 mg/kg DMT + 4 mg/kg harmalas) were given to five adults, while a third (ACL-010) was given to four adults at two dosages. All formulations were safe and well-tolerated, with no serious adverse events. Subjective experiences were similar to traditional ayahuasca, and ACL-010 was rated as comparable or more beneficial.

Data attribution

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