Three Acacia-based formulations of DMT and harmala alkaloids were safe and well tolerated in 9 healthy volunteers who had previously used ayahuasca. No serious adverse events occurred, and physical exams, vital signs, and lab tests showed no clinically significant changes. Participants rated the subjective experience of all formulations as generally similar to ayahuasca, and one formulation (ACL-010) was rated as similar or more beneficial. Four-week follow-up measures of psychological wellbeing and perceptual effects showed little difference between formulations. The small sample and open-label design limit generalizability, but the results suggest Acacia-derived DMT formulations are a feasible alternative for future clinical trials.
Acute subjective experiences induced by psychedelics, particularly mystical experiences, are linked to therapeutic benefits such as reduced depression, anxiety, and addiction. This study assessed a purified encapsulated DMT-harmala alkaloid product in 17 dosing sessions with 9 healthy volunteers. Strong positive correlations were found between total dose and scores on mystical experience questionnaires (MEQ-30 and SIME). The formulation reliably produced intense subjective experiences, exceeding those reported in most naturalistic ayahuasca studies, and these experiences were robustly associated with beneficial persisting psychological effects. The findings suggest this formulation warrants further clinical trials to evaluate its therapeutic potential and safety.