Safety, Tolerability, and Efficacy of Sublingual Microdoses of 5-MeO-DMT for Depression and Anxiety (5-MeO-DMT)

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.

The study, sponsored by Biomind Labs Inc., aims to assess the impact of 5-MeO-DMT on mood, anxiety, and emotional well-being, alongside its pharmacokinetics (how the body processes the drug).

Safety measures include regular monitoring of vital signs, electrocardiograms (ECGs), and biochemical markers to identify potential side effects. Participants, aged 40-80, must meet specific anxiety and depression criteria but cannot have prior psychedelic experience or be on psychoactive medication. Neurocognitive and psychological assessments will evaluate changes in mood, anxiety, and cognitive function throughout the study. The findings will contribute to understanding 5-MeO-DMT’s clinical potential for mental health treatment.

Topic Depression Anxiety Healthy Subjects Safety Neuroscience
Compound 5-MeO-DMT Placebo
Country Argentina
Visit trial

Trial Details



Trial Number

Papers

Safety and tolerability of multiple sublingual microdoses of 5-MeO-DMT in adults with moderate symptoms of depression and/or anxiety: a randomized, double-blind, placebo-controlled study
This Phase I clinical trial (n=36) of sublingual 5-MeO-DMT (6-12 mg weekly doses over four weeks) in adults with moderate to high anxiety/depression demonstrated good safety and tolerability with no significant adverse events, rapid absorption with peak plasma concentrations at 20 minutes, dose-dependent neurophysiological modulation without full psychedelic effects, and maintenance of normal cognitive and behavioral function.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.