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

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ClinicalTrials.gov Identifier: NCT02451072
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Franz X. Vollenweider, Psychiatric University Hospital, Zurich

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE May 21, 2015
Last Update Posted Date February 1, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
fMRI brain activity (BOLD signal) [ Time Frame: two MRI acquisitions separated by a break of 160 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
  • associations between personality traits, subjective experiences, and mood changes and the changes in BOLD signal [ Time Frame: 14 hours ]
  • repeated assessment of subjective effects with validated questionnaires [ Time Frame: 14 hours ]
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 The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers
Official Title  ICMJE The Role of 5-HT2A Receptor on Perception of the Self and Perception of Meaning in Healthy Volunteers
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Placebo
    Capsules containing mannitol looking identical to LSD per os
  • Drug: LSD
    100µg per os, single dose
    Other Name: Lysergic acid diethylamide
  • Drug: Ketanserin
    40mg per os, single dose looking identical to LSD per os
    Other Name: Sufrexal
Study Arms  ICMJE 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
Interventions:
  • Drug: Placebo
  • Drug: LSD
  • Drug: Ketanserin
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: May 18, 2015)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (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 NCT02451072
Other Study ID Numbers  ICMJE LSDPUK-126
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Franz X. Vollenweider, Psychiatric University Hospital, Zurich
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Psychiatric University Hospital, Zurich
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franz X. Vollenweider, Prof. Dr. Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich
PRS Account Psychiatric University Hospital, Zurich
Verification Date January 2016

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