Clinical TrialHealthy VolunteersLSDPlaceboCompleted

Neuronal Correlates of Altered States of Consciousness (5HT2A-fMRI)

Randomised, two-period crossover fMRI study (n=24) in healthy volunteers comparing single oral LSD (100 µg) with placebo to assess neuronal correlates of altered consciousness.

Target Enrollment
24 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

This study uses a random-order two-period crossover design in healthy volunteers to compare normal and pharmacologically induced altered states of consciousness using fMRI.

Altered states are induced with a single oral dose of LSD (100 µg) versus an identical-appearing mannitol placebo; subjective alterations will be correlated with objective imaging measures to identify neuronal correlates of psychotic-like perception changes.

Outcomes inform the relationship between subjective phenomenology and brain activation patterns, with implications for understanding early schizophrenia and consciousness research.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

LSD

experimental

Two-period crossover (LSD vs placebo) within-subject design for fMRI assessment.

Interventions

  • LSD100 µg
    via Oral• single dose• 1 doses total

    Single oral 100 µg dose

  • Placebo
    via Oral• single dose

    Mannitol capsule visually identical to LSD

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age between 25 and 65 years
  • 2. Understanding of the German language
  • 3. Understanding the procedures and the risks associated with the study
  • 4. Participants must be willing to adhere to the protocol and sign the consent form
  • 5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • 6. Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session, as well as during the study day.
  • 7. Women of childbearing potential must have a negative pregnancy test at the beginning of the study and before each study session.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Chronic or acute medical condition
  • 2. Current or previous major psychiatric disorder
  • 3. Psychotic disorder in first-degree relatives
  • 4. Illicit substance use (except tetrahydrocannabinol (THC)-containing products) more than 10 times or any time within the previous month.
  • 5. Pregnant or nursing women.
  • 6. Participation in another clinical trial (currently or within the last 30 days)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2014-12-01
    End: 2015-09-10
  • Compounds
    LSDPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital — Basel, Switzerland

Related Publications

Open Accessindividual

A Single Dose of LSD Does Not Alter Gene Expression of the Serotonin 2A Receptor Gene (HTR2A) or Early Growth Response Genes (EGR1-3) in Healthy Subjects

This double-blind, placebo-controlled crossover study (n=15) investigated whether a single dose of LSD (100 µg) alters gene expression in whole blood as a marker of tolerance. Results show no significant changes in the expression of the 5-HT2A receptor gene or early growth response genes (EGR1-3) at 1.5 or 24 hours post-administration.

Published
Journal
Frontiers in Pharmacology
Authors
Borgwardt, S., Dolder, P. C., Grünblatt, E., Liechti, M. E., Müller, F.

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