Clinical TrialHealthy VolunteersLSDPlaceboCompleted

A randomised, double-blind, placebo-controlled trial to study the effects of repeated microdoses of lysergic acid diethylamide (LSD) on creativity and brain activity in healthy adult males

This randomized, double-blind, placebo-controlled trial (n=80) will study the effects of repeated microdoses of lysergic acid diethylamide (LSD) on creativity and brain activity in healthy adult males. Participants will receive either 10 µg of LSD or a placebo, dissolved in water in 1 ml oral syringes, taken once every three days for a total of 14 doses over a 41-day regimen.

Target Enrollment
80 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group study in healthy male volunteers (25–60 years) comparing repeated microdoses of LSD (10 µg) with matched placebo over 14 dosing sessions across 41 days.

Primary assessments include creative thinking (Alternate Uses Test) and EEG measures (mismatch negativity) at baseline, 2 hours after first administration (Day 1), and 2 days after the final administration (Day 43). Adherence is monitored via participant-recorded dosing videos; a titration amendment permits starting at 5 µg with +1 µg increments to a 10 µg maximum if poorly tolerated.

Study Protocol

Preparation

sessions

Dosing

14 sessions

Integration

sessions

Study Arms & Interventions

LSD microdose

experimental

10 µg LSD every three days for 14 doses (41-day regimen); adherence via video; mid-study titration allowed if not tolerated.

Interventions

  • LSD10 - 10 µg
    via Oral• every 3 days• 14 doses total

    Dissolved in water in 1 ml oral syringes; adherence monitored by participant video. Titration protocol: start 5 µg and increase +1 µg per dose up to 10 µg if required.

Placebo

inactive

Water placebo in identical 1 ml oral syringes, same schedule and adherence monitoring.

Interventions

  • Placebo
    via Oral• every 3 days• 14 doses total

    Water in 1 ml oral syringes; adherence monitored by participant video.

Participants

Ages
25 – 60
Sexes
male

Inclusion Criteria

  • Participant is willing and able to give informed consent for participation in the trial.
  • Males aged 25-60 years inclusive.

Exclusion Criteria

  • Current use of any prescribed psychotropic medication.
  • Significant renal or hepatic impairment as judged by study clinicians.
  • Cardiovascular conditions including abnormal heart rate or blood pressure to be checked at screening; threshold: >160 mmHg systolic or >90 mmHg diastolic averaged across four assessments on screening day.
  • Any unstable medical or neurologic condition.
  • Current or past history of schizophrenia or other psychotic disorders, or bipolar I or II disorder as assessed by the Standard MINI.
  • Imminent risk of suicide as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • Lifetime presence of major depressive disorder as assessed by the MINI.
  • Current diagnosis of PTSD, anxiety and panic disorders, OCD, dysthymic disorder, anorexia, or bulimia.
  • Body weight <50 kg or >120 kg.
  • Substance dependence in the previous 3 months as assessed with a New Zealand modified version of the NM-ASSIST.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment80 participants
  • Timeline
    Start: 2019-11-19
    End: 2022-03-01
  • Compounds
    LSDPlacebo
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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