Non-randomised, sequential Phase I inhaled DMT study (n=27) in healthy volunteers; two ascending inhaled doses given in fixed order on the same day, 2 hours apart.
This Phase I sequential dose-escalation study evaluates the acute and subacute effects of inhaled N,N-dimethyltryptamine in healthy volunteers. Participants are enrolled in five cohorts, each receiving two inhaled doses in a fixed ascending order on the same day with a 2-hour interval.
Dosing is administered via a vaporizer device; cohort dose pairs range from 5→20 mg to 15→60 mg. Outcomes include safety and tolerability measures and assessment of acute and subacute subjective effects.
No structured psychological support is provided as part of the dosing sessions.
Up to 2 inhaled doses (5 mg then 20 mg) in fixed order, 2 h apart; cohort size 5.
Initial 5 mg then 20 mg, 2 h apart; cohort of 5.
Up to 2 inhaled doses (7.5 mg then 30 mg) in fixed order, 2 h apart; cohort size 5.
Initial 7.5 mg then 30 mg, 2 h apart; cohort of 5.
Up to 2 inhaled doses (10 mg then 40 mg) in fixed order, 2 h apart; cohort size 5.
Initial 10 mg then 40 mg, 2 h apart; cohort of 5.
Up to 2 inhaled doses (12.5 mg then 50 mg) in fixed order, 2 h apart; cohort size 5.
Initial 12.5 mg then 50 mg, 2 h apart; cohort of 5.
Up to 2 inhaled doses (15 mg then 60 mg) in fixed order, 2 h apart; cohort size 5.
Initial 15 mg then 60 mg, 2 h apart; cohort of 5.