MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers
Robin J Murphy, Rachael Sumner, William Evans, David B Menkes, Ingo Lambrecht, Rhys Ponton, Frederick Sundram, Nicholas Hoeh, Sanya Ram, Lisa Reynolds, Suresh Muthukumaraswamy
Trials April 23, 2021 DOI: 10.1186/s13063-021-05243-3 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Peer reviewed |
|---|---|
| Sample size | 80 |
| Population | Healthy male participants |
| Dose | 10 μg |
| Duration | 6-week treatment protocol |
| Topics | Addiction Anxiety Psilocybin LSD |
| Keywords | Mood Placebo Clinical psychology Clinical trial Hallucinogen Cognition Alternative medicine |
| Citations | 23 |
| Key findings | The study aims to rigorously examine claims of cognitive and emotional benefits from microdosing LSD using objective measures, but no results are reported as the trial is registered and not yet completed. |
Abstract
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 μg 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.
Trial Registration: ACTRN12621000436875 . Registered on 19 February 2021.