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NCT Number: NCT02308969

Neuronal Correlates of Altered States of Consciousness

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).

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Key information

Conditions

Healthy Hallucinations Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospital

Basel, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 25 and 65 years
  • Understanding of the German language
  • Understanding the procedures and the risks associated with the study
  • Participants must be willing to adhere to the protocol and sign the consent form
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • 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.
  • Women of childbearing potential must have a negative pregnancy test at the beginning of the study and before each study session.

Exclusion criteria

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

Treatment and study plan

LSD

Drug

100ug per os, single dose

Other names: Lysergic Acid Diethylamide

Placebo

Drug

Capsules containing mannitol looking identical to LSD

Primary outcomes

  1. fMRI brain activity

    Time frame: 1 hour

    Associations 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 outcomes

  1. Physiological effects (Association of alterations in consciousness and autonomic nervous system reactions (blood pressure, heart rate, pupil size)

    Time frame: 24 hours

    Association of alterations in consciousness and autonomic nervous system reactions (blood pressure, heart rate, pupil size)

  2. Plasma hormone levels (Associations of alterations in consciousness with plasma hormone levels)

    Time frame: 24 hours

    Associations of alterations in consciousness with plasma hormone levels

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: 5HT2A-fMRI

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2014
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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