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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT02451072
• Date of registration: 13/05/2015
• Prospective Registration: No
• Primary sponsor: Psychiatric University Hospital, Zurich
• Public title: The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers
• Scientific title: The Role of 5-HT2A Receptor on Perception of the Self and Perception of Meaning in Healthy Volunteers
• Date of first enrolment: March 2015
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02451072
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

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

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: LSD

Drug: Ketanserin

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

repeated assessment of subjective effects with validated questionnaires [Time Frame: 14 hours]

associations between personality traits, subjective experiences, and mood changes and the changes in BOLD signal [Time Frame: 14 hours]

Secondary ID(s)

LSDPUK-126

Source(s) of Monetary Support

Please refer to primary and secondary sponsors