4.4 Article

MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers

Journal

TRIALS
Volume 22, Issue 1, Pages -

Publisher

BMC
DOI: 10.1186/s13063-021-05243-3

Keywords

Microdosing; Lysergic acid diethylamide; Psychedelics; Cortical plasticity; Cortical connectivity; Personality; Creativity; Long-term potentiation; Randomised controlled trial

Funding

  1. Health HRC [20/845]

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This study aims to rigorously examine the benefits of microdosing psychedelics in cognitive and emotional domains, as well as explore the potential therapeutic implications for conditions like depression and addiction. By pairing a comparable dosing protocol with objective measures, the study aims to provide more concrete evidence to support the claims made in the grey literature.
Background: Regular ingestion of sub-hallucinogenic doses of psychedelics, referred to as microdosing, has gained increasing popularity and attention in the press and in online forums, with reported benefits across multiple cognitive and emotional domains. Rigorously controlled studies to date, however, have been limited in scope and have failed to produce results comparable to those reported in the grey literature. Methods: Eighty healthy male participants will receive 14 doses of placebo or 10 mu g lysergic acid diethylamide orally every 3rd day over a 6-week treatment protocol. A battery of personality, creativity, mood, cognition, and EEG plasticity measures, as well as resting-state fMRI imaging, will be administered at baseline and at the end of the protocol. Creativity, mood, and plasticity measures will additionally be assessed in the acute phase of the first dose. Daily functioning will be monitored with questionnaires and a wearable sleep and activity tracker. Discussion: This study will rigorously examine the claims presented in the microdosing grey literature by pairing a comparable dosing protocol with objective measures. Potential therapeutic implications include future clinical trials to investigate microdosed psychedelics as a standalone treatment or as an augmentation of psychotherapy in the treatment of depression, addiction, eating disorders, obsessive-compulsive disorders, and palliative care.

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