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

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ClinicalTrials.gov Identifier: NCT02308969
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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).

Condition or disease Intervention/treatment Phase
Healthy Drug: LSD Drug: Placebo Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neuronal Correlates of Altered States of Consciousness
Study Start Date : December 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Placebo, LSD
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two treatment conditions in the same subject.
Drug: LSD
100ug per os, single dose
Other Name: Lysergic Acid Diethylamide

Drug: Placebo
Capsules containing mannitol looking identical to LSD




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308969


Locations
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Switzerland
University Hospital
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02308969    
Other Study ID Numbers: EKNZ 2014-344
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015
Keywords provided by University Hospital, Basel, Switzerland:
altered state of consciousness
functional magnetic resonance imaging (fMRI)
hallucination
model psychosis
serotonin receptor
LSD
Additional relevant MeSH terms:
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Lysergic Acid Diethylamide
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists