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.

The trial includes a titration protocol for those not tolerating the standard dose well, and can be paused in case of necessary self-isolation. The study will measure creative thinking, open-mindedness, and convergent thinking, along with EEG recordings for brain activity. It aims to rigorously evaluate the purported benefits of psychedelic microdosing and assess its potential as an alternative treatment regimen for depression.

Trial Details



Trial Number

Sponsors & Collaborators

MindBio Therapeutics
MindBio Therapeutics is conducting clinical research exploring the effects of microdosing psychedelic medicines to treat a range of medical conditions such as depression, anxiety, PTSD, panic disorder, chronic pain and opioid addiction.

Papers

Multimodal creativity assessments following acute and sustained microdosing of lysergic acid diethylamide
This re-analysis of an RCT (n=80) finds no effect of LSD microdosing (10µg, x14) on creativity in healthy adult males. Participants received either LSD or placebo every third day for six weeks, with creativity assessed using multiple tests at baseline, during acute dosing, and after the six-week regimen.

LSD increases sleep duration the night after microdosing
This Phase I RCT (n=80) examined the effects of microdosing LSD (10μcg; 14x; 6w) on sleep in healthy adult male volunteers, with doses self-administered every third day and sleep monitored through a commercially available sleep/activity tracker. The results showed that participants in the LSD group slept an extra 24.3 minutes per night on the night after microdosing compared to the placebo group, with no changes in sleep stages or physical activity.

Acute mood-elevating properties of microdosed LSD in healthy volunteers: a home-administered randomised controlled trial
This placebo-controlled, randomized, naturalistic study (n=80) of repeated microdoses of LSD (10μg, 14x, 6w) finds improved ratings, on dosing days, on creativity, connectedness, energy, and other wellness ratings. Though these transient changes were found, no enduring changes to mood and cognition were observed.

Pharmacokinetics and pharmacodynamics of sublingual microdosed lysergic acid diethylamide in healthy adult volunteers
This re-analysis of a Phase I RCT (n=80) examines the pharmacokinetics (how the body affects a drug) of LSD microdosing (10µg; 14x; 6w) in healthy adult males. The study established a one-compartment pharmacokinetic model showing an elimination half-life of 3.08h, found minimal physiological effects (<15% change in heart rate), noted possible influence of CYP enzymes on drug metabolism, and reported no changes in peripheral BDNF levels.

Data attribution

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