Clinical TrialDepressive Disorders5-MeO-DMT5-MeO-DMT5-MeO-DMTPlaceboCompleted

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.

Target Enrollment
40 participants
Study Type
Phase I/II interventional
Design
Randomized, triple Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

5-MeO-DMT 6 mg

experimental

Sublingual 6 mg once weekly for four weeks.

Interventions

  • 5-MeO-DMT6 mg
    via Sublingual• weekly• 4 doses total

5-MeO-DMT 9 mg

experimental

Sublingual 9 mg once weekly for four weeks.

Interventions

  • 5-MeO-DMT9 mg
    via Sublingual• weekly• 4 doses total

5-MeO-DMT 12 mg

experimental

Sublingual 12 mg once weekly for four weeks.

Interventions

  • 5-MeO-DMT12 mg
    via Sublingual• weekly• 4 doses total

Placebo

inactive

Matched sublingual placebo once weekly for four weeks.

Interventions

  • Placebo
    via Sublingual• weekly• 4 doses total

    Matched sublingual placebo formulation

Participants

Ages
40 – 80
Sexes
Male & Female

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:
  • STAI-S (State) score of ≥20 for men and ≥23 for women
  • STAI-T (Trait) score of ≥20 for men and ≥26 for women
  • BDI score of ≥21 indicating moderate to severe depressive symptoms.
  • Participants may meet criteria for either anxiety, depression, or both, provided they meet the respective thresholds.

Exclusion Criteria

  • Liver dysfunction.
  • Cardiovascular conditions including uncontrolled hypertension, angina, clinically significant ECG abnormalities (e.g., atrial fibrillation), or TIA within last 6 months.
  • Stroke or peripheral/pulmonary vascular disease without active claudication.
  • Blood pressure >140/90 mmHg.
  • Epilepsy or 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 anxiolytics (including suicidal ideation).
  • Regular use of prescribed psychoactive medications (e.g., benzodiazepines), medications affecting serotonin neurons (e.g., ondansetron), or MAOIs.
  • Use of potent metabolic inducers or inhibitors (inducers e.g., rifampicin, anticonvulsants, nevirapine, efavirenz; inhibitors e.g., HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin).

Study Details

Locations

Hospital Descentralizado Dr. Marcial V. Quiroga. — San Juan, Rivadavia, Argentina

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