The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers
The Role of 5-HT2A Receptor on Perception of the Self and Perception of Meaning in Healthy Volunteers
1 other identifier
interventional
25
1 country
1
Brief Summary
Aim of the present study is to investigate the neuronal correlates of self and of personal meaning as well as the role of the serotonin (5-HT) 2A receptor system in these processes using functional magnetic resonance imaging (fMRI) and psychometric and cognitive measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 1, 2016
January 1, 2016
10 months
May 13, 2015
January 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
fMRI brain activity (BOLD signal)
two MRI acquisitions separated by a break of 160 minutes
Secondary Outcomes (2)
associations between personality traits, subjective experiences, and mood changes and the changes in BOLD signal
14 hours
repeated assessment of subjective effects with validated questionnaires
14 hours
Study Arms (1)
Placebo, LSD, Ketanserin/LSD
EXPERIMENTALCross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but three treatment conditions in the same subject
Interventions
100µg per os, single dose
40mg per os, single dose looking identical to LSD per os
Eligibility Criteria
You may qualify if:
- Healthy male and female volunteers at the age of 20-40
- Willing and capable to give informed consent for study participation as documented by signature after the nature of the study has been thoroughly explained
- Willing to refrain from drinking alcohol the day before testing session, from drinking alcohol and caffeinated drinks at the testing days and from consuming psychoactive substances 2 weeks before testing days and for the duration of the study
- Able and willing to comply with all study requirements
- MRI-compatible body shape and size (Body mass index \[BMI\] 17-30)
- Right-handedness
You may not qualify if:
- Poor knowledge of the German language
- Previous significant adverse response to a hallucinogenic drug
- Participation in another study where pharmaceutical compounds are given within the 30 days preceding and during the present study
- Self or first-degree relatives with present or antecedent psychiatric disorders
- Present or antecedent alcohol/drug dependence or present alcohol/drug abuse
- History of head trauma, fainting, seizures, or electroconvulsive therapy
- Recent cardiac or brain surgery
- Current use of medication known to affect brain function (e.g. benzodiazepines, antihistamines, aspirin, beta blockers, theophylline, acetazolamide, etc.)
- Concomitant therapy with potent inhibitors of cytochrome P-450 isoenzyme 3A4 (HIV protease inhibitors, macrolide antibiotics, acylderivative anti-infective agents)
- Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
- Presence of psychiatric disorder
- Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardial infarction within the past 6 months, coronary spastic angina)
- Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
- Liver or renal disease
- Pregnant or breastfeeding women (a urine pregnancy test will be done before each session for all women capable of bearing children)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich
Zurich, 8032, Switzerland
Related Publications (2)
Burt JB, Preller KH, Demirtas M, Ji JL, Krystal JH, Vollenweider FX, Anticevic A, Murray JD. Transcriptomics-informed large-scale cortical model captures topography of pharmacological neuroimaging effects of LSD. Elife. 2021 Jul 27;10:e69320. doi: 10.7554/eLife.69320.
PMID: 34313217DERIVEDPreller KH, Burt JB, Ji JL, Schleifer CH, Adkinson BD, Stampfli P, Seifritz E, Repovs G, Krystal JH, Murray JD, Vollenweider FX, Anticevic A. Changes in global and thalamic brain connectivity in LSD-induced altered states of consciousness are attributable to the 5-HT2A receptor. Elife. 2018 Oct 25;7:e35082. doi: 10.7554/eLife.35082.
PMID: 30355445DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franz X. Vollenweider, Prof. Dr.
Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 21, 2015
Study Start
March 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
February 1, 2016
Record last verified: 2016-01