5HT2A-fMRI: Neuronal Correlates of Altered States of Consciousness

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT02308969

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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).

Study Design

Study Type:

Interventional

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 :

Dec 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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: LSD 100ug per os, single dose Other Names: Lysergic Acid Diethylamide Drug: Placebo Capsules containing mannitol looking identical to LSD

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: LSD

100ug per os, single dose

Other Names:

Lysergic Acid Diethylamide

Drug: Placebo

Capsules containing mannitol looking identical to LSD

Outcome Measures

Primary Outcome Measures

fMRI brain activity [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

Physiological effects (Association of alterations in consciousness and autonomic nervous system reactions (blood pressure, heart rate, pupil size) [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) [24 hours]
Associations of alterations in consciousness with plasma hormone levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)