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Neuronal Correlates of Altered States of Consciousness

Neuronal Correlates of Altered States of Consciousness

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02308969
Acronym
5HT2A-fMRI
Enrollment
24
Registered
2014-12-05
Start date
2014-12-31
Completion date
2015-09-30
Last updated
2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

altered state of consciousness, functional magnetic resonance imaging (fMRI), hallucination, model psychosis, serotonin receptor, LSD

Brief summary

The aim of the present study is to assess the neuronal correlates of alterations in waking consciousness pharmacologically induced by a 5-hydroxytryptamine (HT)2A receptor agonist in healthy subjects using functional magnetic resonance imaging (fMRI).

Detailed description

Functional neuroimaging may be useful in the diagnosis and characterization of early schizophrenia. However, little is known about how the subjectively experienced alterations in consciousness and perception are related with objective neuroimaging measures. The present study explores the association of subjective alterations and objective imaging findings and will inform us on the neuronal correlates of psychotic states and whether subjective alterations in perception translate into neuronal activation patterns that can be objectively measured in a brain scanner. Therefore, alterations in consciousness will be assessed in 20 healthy subjects using a random order 2-period (normal and altered state of consciousness) cross-over design. Alterations in consciousness will be induced by the hallucinogenic 5-hydroxytryptamine (HT)2A receptor agonist (5-HT2A) receptor agonist lysergic acid diethylamide (LSD).

Interventions

DRUGPlacebo

Capsules containing mannitol looking identical to LSD

DRUGLSD

100ug per os, single dose

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

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

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)

Design outcomes

Primary

MeasureTime frameDescription
fMRI brain activity1 hourAssociations between fMRI activity (resting state, amygdala-BOLD response to fear and frontoparietal connectivity during working memory processing) and alterations in waking consciousness pharmacologically induced by LSD

Secondary

MeasureTime frameDescription
Physiological effects (Association of alterations in consciousness and autonomic nervous system reactions (blood pressure, heart rate, pupil size)24 hoursAssociation of alterations in consciousness and autonomic nervous system reactions (blood pressure, heart rate, pupil size)
Plasma hormone levels (Associations of alterations in consciousness with plasma hormone levels)24 hoursAssociations of alterations in consciousness with plasma hormone levels

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026