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

September 24, 2015 updated by: University Hospital, Basel, Switzerland
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

24

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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: Placebo
Capsules containing mannitol looking identical to LSD
Drug: LSD
100ug per os, single dose
Other Names:
  • Lysergic Acid Diethylamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Matthias E Liechti, MD, MAS, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2014-344

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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