HealthyNCT02451072
The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers
A study testing LSD and Ketanserin in people with Healthy, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LSD and Ketanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich
Zurich, 8032
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Placebo, LSD, Ketanserin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Capsules containing mannitol looking identical to LSD per os
LSDDrug
Also called Lysergic acid diethylamide
100µg per os, single dose
KetanserinDrug
Also called Sufrexal
40mg per os, single dose looking identical to LSD per os
| Study group | Role | What they receive |
|---|---|---|
| Placebo, LSD, Ketanserin/LSD | Experimental | 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 Receives: Drug: Placebo; Drug: LSD; Drug: Ketanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI brain activity (BOLD signal)
Measured: 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
Measured: 14 hours
repeated assessment of subjective effects with validated questionnaires
Measured: 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franz X. Vollenweider, Psychiatric University Hospital, Zurich
- Investigators
- Franz X. Vollenweider, Prof. Dr., Principal investigator, Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451072
- Sponsor's protocol ID
- LSDPUK-126
- Status last verified
- Jan 2016
- First submitted
- 13 May 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34313217Preller 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.
PubMed 30355445
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 5-HT2A Receptor on Perception of the Self and Perception of Meaning in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02451072
- Acronym / sponsor ID
- LSDPUK-126
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo, LSD, Ketanserin/LSD | Experimental | Drug: Placebo, Drug: LSD, Drug: KetanserinCross-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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboCapsules containing mannitol looking identical to LSD per os | Drug | Placebo, LSD, Ketanserin/LSD |
| LSDAlso: Lysergic acid diethylamide100µg per os, single dose | Drug | Placebo, LSD, Ketanserin/LSD |
| KetanserinAlso: Sufrexal40mg per os, single dose looking identical to LSD per os | Drug | Placebo, LSD, Ketanserin/LSD |
Primary outcome
fMRI brain activity (BOLD signal)
Time frame: two MRI acquisitions separated by a break of 160 minutes
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Derived from this study: PubMed 34313217Burt 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.
- Derived from this study: PubMed 30355445Preller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franz X. Vollenweider, Prof. Dr. principal investigator
Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSD and Ketanserin in people with Healthy, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI brain activity (BOLD signal) (time frame: two MRI acquisitions separated by a break of 160 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451072, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.