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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

Tracking Information
First Submitted Date  ICMJE November 18, 2014
First Posted Date  ICMJE December 5, 2014
Last Update Posted Date September 25, 2015
Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuronal Correlates of Altered States of Consciousness
Official Title  ICMJE Neuronal Correlates of Altered States of Consciousness
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: LSD
    100ug per os, single dose
    Other Name: Lysergic Acid Diethylamide
  • Drug: Placebo
    Capsules containing mannitol looking identical to LSD
Study Arms  ICMJE 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.
Interventions:
  • Drug: LSD
  • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2015)
24
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2014)
20
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02308969
Other Study ID Numbers  ICMJE EKNZ 2014-344
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP