Clinical TrialHealthy Volunteers5-MeO-DMTPlaceboNot yet recruiting

Effects of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) administered by intramuscular injection on frequency oscillatory power bands in healthy adults

Single-blind, non-randomised, single-group repeated-measures study (n=15) testing IM 5‑MeO‑DMT (3, 6, 9 mg) and saline placebo across four sessions to assess MEG/fMRI markers and wellbeing.

Target Enrollment
15 participants
Study Type
Phase I interventional
Design
Non-randomized, single Blind

Detailed Description

Fifteen healthy volunteers will attend four dosing days spaced two weeks apart in a single-group, non-randomised, single-blind design; each session involves a single IM administration of 5‑MeO‑DMT (3 mg, 6 mg or 9 mg) or inactive saline.

Primary assessments are MEG-derived frequency oscillatory power bands (eyes closed) and post-acute fMRI functional connectivity measured ~90 minutes post-dose (12-minute resting-state MEG and 6-minute anatomical/functional MRI acquisitions).

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

5-MeO-DMT IM

experimental

Single-group repeated measures: each participant receives IM 5‑MeO‑DMT (3 mg, 6 mg, 9 mg) and inactive saline placebo across four sessions.

Interventions

  • 5-MeO-DMT3 - 9 mg
    via IM• single dose per session• 3 doses total

    Active doses 3 mg, 6 mg, 9 mg administered across separate sessions.

  • Placebo
    via IM• single dose per session• 1 doses total

    Inactive saline placebo administered in one session.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • Physically and mentally healthy.
  • Good command of the English language.
  • Prior experience with a psychedelic without experiencing adverse events.
  • Normal baseline ECG (determined by study medic).
  • Informed consent.
  • No psychedelic use within 2 weeks prior to the experiment.
  • Email access.
  • No anaemia.
  • Normal healthy body mass index (i.e., between 18.5-24.9).
  • Not use caffeine or nicotine 2 hours before or 6 hours after the dose.

Exclusion Criteria

  • Not physically and mentally healthy.
  • No command of the English language.
  • No prior experience with a psychedelic without experiencing adverse events.
  • Abnormal baseline ECG (determined by study medic).
  • No informed consent.
  • Psychedelic use within 2 weeks prior to the experiment.
  • No email access.
  • Anaemia.
  • Abnormal body mass index (i.e., below 18.5 or above 24.9).
  • Not use caffeine or nicotine 2 hours before or 6 hours after the dose.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomizedsingle Blind
  • Target Enrollment15 participants
  • Timeline
    Start: 2023-09-01
    End: 2025-01-01
  • Compounds
    5-MeO-DMTPlacebo
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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