This Phase I/II randomised, triple-blind, placebo-controlled trial (n=40) will investigate the safety, tolerability, and potential therapeutic effects of sublingual 5-MeO-DMT (6 mg, 9 mg, or 12 mg) in individuals with elevated symptoms of anxiety and depression. Participants will receive one dose per week for four weeks, with monitoring throughout the trial.
Randomized, triple-blind, placebo-controlled Phase I/II trial in 40 participants assessing a novel sublingual 5-MeO-DMT formulation (BMND08) at 6, 9 and 12 mg versus placebo, administered once weekly for four weeks.
Phase I endpoints focus on safety and pharmacokinetics (vitals, ECGs, biochemistry, plasma Cmax/Tmax/AUC); Phase II explores signals of efficacy on mood and anxiety using validated scales (BDI-II, STAI, DASS-21) and neurocognitive testing.
Assessments include EEG, serial pharmacokinetic sampling, biochemical panels, acute subjective ratings (MEQ, EDI, PES), and cognitive batteries (FAS, PASAT, DSS); adverse events and SAEs are monitored throughout.
The study aims to characterise tolerability and safety of sub-psychedelic sublingual 5-MeO-DMT and generate data to inform larger clinical trials for depression and anxiety.
Sublingual 6 mg once weekly for four weeks.
Sublingual 9 mg once weekly for four weeks.
Sublingual 12 mg once weekly for four weeks.
Matched sublingual placebo once weekly for four weeks.
Matched sublingual placebo formulation