The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers

January 29, 2016 updated by: Franz X. Vollenweider, Psychiatric University Hospital, Zurich

The Role of 5-HT2A Receptor on Perception of the Self and Perception of Meaning in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study aims at identifying the contribution of the 5-HT2A receptor system to the formation of self and personal meaning in normal and altered states of consciousness. Specifically, the effect of the 5-HT2/1/6/7 receptor agonist lysergic acid diethylamide (LSD) on self-consciousness, perception and the making of meaning will be assessed in 25 healthy subjects using a randomized, placebo-controlled, double blind, cross-over design. Furthermore, the contribution of the 5-HT2A receptor to these functions shall be assessed by pretreatment with the specific 5-HT2A antagonist ketanserin.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • Switzerland
      • Zurich, Switzerland, 8032
        • Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich

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

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Inability to lie still for about 60 minutes (e.g. because of sneezing, itching, tremor, pain)
  • Metal parts in the body (piercings, brain aneurysm clip, implanted neural stimulator/cardiac pacemaker/defibrillator/Swan Ganz catheter/insulin pump, cochlear implant); metal shrapnel or bullet, ocular foreign body (e.g. metal shavings); current or previous job in metalworking industry
  • Claustrophobia

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo, LSD, Ketanserin/LSD
Cross-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
Drug: Placebo
Capsules containing mannitol looking identical to LSD per os
Drug: LSD
100µg per os, single dose
Other Names:
  • Lysergic acid diethylamide
Drug: Ketanserin
40mg per os, single dose looking identical to LSD per os
Other Names:
  • Sufrexal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI brain activity (BOLD signal)
Time Frame: two MRI acquisitions separated by a break of 160 minutes
two MRI acquisitions separated by a break of 160 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
associations between personality traits, subjective experiences, and mood changes and the changes in BOLD signal
Time Frame: 14 hours
14 hours
repeated assessment of subjective effects with validated questionnaires
Time Frame: 14 hours
14 hours

Collaborators and Investigators

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

Sponsor

Psychiatric University Hospital, Zurich

Investigators

  • Principal Investigator: Franz X. Vollenweider, Prof. Dr., Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich

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

March 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSDPUK-126

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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