CompletedPhase 1 / Phase 2

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

NCT06816667 · 5-MeO-DMT · Biomind Labs Inc.

Closed to entry

Status

Not accepting participants

Phase 1 / Phase 2

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Number of participants with Adverse Events Coded by MedDRA Following Sublingual Administration of 5-MeO-DMT
Measured over Throughout the 6 weeks of the interventional study.
Maximum Plasma Concentration (Cmax) following sublingual administration of 5-MeO-DMT.
Measured over From baseline at 0 minutes to 120 minutes following administration.
Time to Maximum Plasma Concentration (Tmax) following sublingual administration of 5-MeO-DMT
Measured over From baseline at 0 minutes to 120 minutes following administration.
Area Under the Curve (AUC) following sublingual administration of 5-MeO-DMT.
Measured over From baseline at 0 minutes to 120 minutes following administration.
Elimination Half-life (t1/2) of 5-MeO-DMT.
Measured over From baseline at 0 minutes to 120 minutes following administration.
Mystical Experience Questionnaire (MEQ) Assessment at 40 Minutes Post-Administration
Measured over 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
Measured over 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
Measured over 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.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

40 Years to 80 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: * Voluntary participants aged between 40 and 80 years, regardless of sex. * Must provide written informed consent to participate in the study. * Participants must exhibit moderate to high levels of anxiety and/or depression: * Anxiety levels assessed using the State-Trait Anxiety Inventory (STAI): * STAI-S (State) score of ≥20 for men and ≥23 for women * STAI-T (Trait) score of ≥20 for men and ≥26 for women * Depression levels assessed using the Beck Depression Inventory (BDI): * BDI score of ≥21 indicating the presence of moderate to severe depressive symptoms. * Participants may meet the criteria for either anxiety, depression, or both, as long as they meet the respective thresholds for each Exclusion Criteria: * Liver dysfunction * Cardiovascular conditions, including: Uncontrolled hypertension, Angina, Clinically significant ECG abnormalities (e.g., atrial fibrillation), Transient ischemic attack (TIA) within the last 6 months. * Stroke or peripheral/pulmonary vascular disease without active claudication. * Blood pressure exceeding 140 mmHg systolic or 90 mmHg diastolic. * Epilepsy or a history of seizures. * Kidney failure. * Insulin-dependent diabetes. * Chronic obstructive pulmonary disease (COPD). * Increased intracranial or cerebrospinal pressure * Hyperthyroidism * Psychotic symptoms or a family history of psychotic disorders * Prodromal symptoms of schizophrenia or dissociative identity disorder. * Severe symptoms of depression or anxiety requiring immediate treatment with antidepressants or daily anxiolytic medications, especially in cases involving suicidal ideation. * Medications: Regular use of prescribed psychoactive medications, such as: Benzodiazepines, Medications affecting serotonin neurons (e.g., ondansetron), Monoamine oxidase inhibitors (MAOIs). * Drug Interactions: Use of potent metabolic inducers or inhibitors, including: Inducers: Rifampicin (rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, taxol, dexamethasone. or Inhibitors: All HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, and troleandomycin.

Where

1 study site

Facility	City	Region	Country
Hospital Descentralizado Dr. Marcial V. Quiroga.	San Juan	Rivadavia	Argentina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06816667 on ClinicalTrials.gov →

Last updated in the registry 2025-03-05. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

All 3 trials from Biomind Labs Inc. →