This Phase I/II clinical trial investigates the safety, tolerability, and potential therapeutic benefits of a novel sublingual formulation of 5-MeO-DMT. The study uses a randomized, double-blind, placebo-controlled design to evaluate the compound's effects on mood and overall well-being, focusing on participants with elevated symptoms of anxiety and depression. Study Design and Objectives: Participants are divided into four groups: one receiving a placebo and three receiving different doses of 5-MeO-DMT (6 mg, 9 mg, or 12 mg). Each group comprises 10 participants, totaling 40 individuals. The study administers one dose weekly for four weeks, with comprehensive monitoring at baseline and throughout the trial to track changes in emotional, cognitive, and physical well-being. Objectives: Assessing 5-MeO-DMT's impact on anxiety, depression, and emotional well-being. Understanding its pharmacokinetics (absorption, distribution, metabolism, and excretion). Evaluating its safety profile and identifying potential side effects, both mild and severe. Monitoring and Safety Participant safety is prioritized, with medical professionals conducting regular evaluations of vital signs, such as heart rate and blood pressure. Detailed tracking of mood, perception, and physical responses ensures any adverse reactions are documented and analyzed. Sublingual Administration The sublingual route is being studied for its rapid absorption into the bloodstream. Researchers will determine how efficiently the body processes 5-MeO-DMT, its duration in the bloodstream, and its influence on daily life. These findings will inform the practicality of this administration method in clinical settings. Significance of the Study This trial aims to establish a robust safety and tolerability profile for 5-MeO-DMT while exploring its effects on anxiety and depression. The results will also provide essential data to guide future studies into its therapeutic potential for improving mental health and overall quality of life. By addressing both the compound's safety and potential benefits, this research lays the groundwork for developing innovative mental health treatments.
Age range
40 Years – 80 Years
Sex
ALL
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Number of participants with Adverse Events Coded by MedDRA Following Sublingual Administration of 5-MeO-DMT
Timeframe: Throughout the 6 weeks of the interventional study.
Maximum Plasma Concentration (Cmax) following sublingual administration of 5-MeO-DMT.
Timeframe: From baseline at 0 minutes to 120 minutes following administration.
Time to Maximum Plasma Concentration (Tmax) following sublingual administration of 5-MeO-DMT
Timeframe: From baseline at 0 minutes to 120 minutes following administration.
Area Under the Curve (AUC) following sublingual administration of 5-MeO-DMT.
Timeframe: From baseline at 0 minutes to 120 minutes following administration.
Elimination Half-life (t1/2) of 5-MeO-DMT.
Timeframe: From baseline at 0 minutes to 120 minutes following administration.
Mystical Experience Questionnaire (MEQ) Assessment at 40 Minutes Post-Administration
Timeframe: The MEQ will be completed at 40 minutes post-administration during each dosing week (Weeks 1-4) to assess the subjective mystical experiences induced by sublingual 5-MeO-DMT.
Peak Experience Scale (PES) Assessment at 40 Minutes Post-Administration
Timeframe: The PES will be completed at 40 minutes post-administration during each dosing week (Weeks 1-4) to capture the intensity and emotional impact of the 5-MeO-DMT experience.
Ego Dissolution Inventory (EDI) Assessment at 40 Minutes Post-Administration
Timeframe: The EDI will be completed at 40 minutes post-administration during each dosing week (Weeks 1-4) to evaluate the degree of ego dissolution experienced after 5-MeO-DMT consumption.