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
Visit trial
Status Not yet recruiting
Results Published No
Start date 05 November 2022
End date 21 April 2023
Chance of happening 100%
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 8
Sex All
Age 25- 70
Therapy No

Trial Details

Initially, two orally administered DMT (1.0mg/kg) and harmala alkaloid formulations (4mg/kg) will be provided in separate single-dose sessions to 8 healthy volunteers (with prior experience of these substances). After this data is collected, an interim assessment of the psychedelic effect and safety parameters will occur, with one of the formulations being chosen for the next dosage level. The amount given to the 8 participants will be increased to: DMT (1.4mg/kg) and harmala alkaloids (5.6mg/kg). Participants will be given both formulations in a cross-over design (16 psychedelic sessions in total), with a 2-week washout between treatments. Initial treatment group assignment will be randomised. Post-monitoring will occur to assess the more chronic effects of the treatments.

NCT 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.

Data attribution

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