Acute experiences and persisting psychological effects associated with an encapsulated DMT-harmala alkaloid combination: results of a phase 1 study

Acute subjective experiences induced by psychedelics have been identified as important mediators of therapeutic outcomes in many studies. Mystical experiences specifically, have been correlated with a range of therapeutic outcomes including reductions in symptoms of depression, anxiety and addiction. This paper assesses acute subjective experiences induced by an encapsulated DMT-harmala alkaloid product and associations with persisting psychological effects. Botanically derived purified and partially purified formulations containing precise levels of DMT and three harmala alkaloids were administered in 17 dosing sessions to 9 healthy volunteers, with acute subjective experiences data collected via three psychometric instruments (MEQ-30, 5D-ASC, and newly adapted SIME). Pearson's correlations and linear mixed models investigated dose-response relationships and associations with persisting psychological effects. Further analysis compared acute subjective experience scores in this study to ayahuasca drinkers in various naturalistic contexts. Strong, significant positive correlations were identified between total dose and MEQ and SIME scores. The purified DMT-harmala formulation reliably elicited strong acute subjective experiences, with scores exceeding those reported in most previous studies. These experiences were robustly associated with a range of beneficial persisting psychological effects. Findings suggest that this formulation warrants further investigation in controlled clinical trials with relevant patient populations to assess therapeutic potential and safety.