MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers.
Cortical connectivity
Cortical plasticity
Creativity
Long-term potentiation
Lysergic acid diethylamide
Microdosing
Personality
Psychedelics
Randomised controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
23 Apr 2021
23 Apr 2021
Historique:
received:
21
03
2021
accepted:
31
03
2021
entrez:
24
4
2021
pubmed:
25
4
2021
medline:
22
6
2021
Statut:
epublish
Résumé
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. 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. 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. ACTRN12621000436875 . Registered on 19 February 2021.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ACTRN12621000436875 . Registered on 19 February 2021.
Identifiants
pubmed: 33892777
doi: 10.1186/s13063-021-05243-3
pii: 10.1186/s13063-021-05243-3
pmc: PMC8062934
doi:
Substances chimiques
Hallucinogens
0
Lysergic Acid Diethylamide
8NA5SWF92O
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
302Subventions
Organisme : Health Research Council of New Zealand (NZ)
ID : 20/845
Commentaires et corrections
Type : ErratumIn
Références
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