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.
Compound LSD
Country New Zealand
Visit trial
Status
Completed
Results Published
Yes
Start date
19 November 2019
End date
01 March 2022
Chance of happening
100%
Phase
Phase I
Design
Blinded
Type
Interventional
Generation
First
Participants
80
Sex
Male
Age
25- 60
Therapy
No
Trial Details
“Microdosing” refers to repeated administration of psychedelics such as LSD or psilocybin in doses below the threshold for overtly altering perception. There is a growing microdosing subculture and grey literature suggesting that this practice can enhance creativity and productivity, improve mood and favourably modify personality traits. These claimed effects are similar to those observed in clinical studies, in which participants receive much larger, perception-altering doses of LSD or psilocybin. However, there are as yet no controlled, scientific studies of the psychological or physiological effects of repeated psychedelic home-self-administered microdosing. Given the powerful nature of placebo and expectancy effects on self-reports, controlled trials are required to objectively evaluate the effects of microdoses of psychedelic drugs in humans. In this study, we will conduct a randomised controlled trial of repeated microdoses of LSD under schedules similar to those suggested in the grey literature. 80 healthy volunteers will be randomised to receive repeated doses of either inactive placebo or LSD (10 µg oral) under double-blind conditions in a parallel groups design. A variety of physiological and psychological measures will be recorded at baseline and after completion of each of a six-week dosing regimen. Measures will include a validated personality scale and tests of creativity. Electroencephalography will be used to directly measure brain function in each participant before and after treatment. Our results will enable a rigorous evaluation of the purported benefits of psychedelic microdosing and will be relevant to the question of whether microdosing may be a viable alternative treatment regimen for depression, where full psychedelic doses are currently being investigated in clinical trials.NCT Number ACTRN12621000436875
Sponsors & Collaborators
MindBio TherapeuticsMindBio 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 diethylamideThis 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.