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The Neurobiological Effect of 5-HT2AR Modulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03289949
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Information provided by (Responsible Party):
Gitte Moos Knudsen, Rigshospitalet, Denmark

Brief Summary:
The investigators wish to investigate neurobiological effects of serotonin 2A receptor modulation in healthy volunteers, contrasting effects of an agonist (psilocybin) and an antagonist (ketanserin). Magnetic resonance imaging (MRI) and positron emission tomography (PET) will be used as neuroimaging tools.

Condition or disease Intervention/treatment Phase
Basic Science Drug: Psilocybine Drug: Ketanserin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Neurobiological Effect of 5-HT2AR Modulation
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Project 1
After baseline MRI & 5-HT2AR PET-imaging, participants will be allocated to undergo either one oral dose of psilocybin or one oral dose of ketanserin. After drug administration, participants will undergo two CIMBI-36 PET scans.
Drug: Psilocybine
Oral dose of psilocybin.
Other Name: Psilocybin

Drug: Ketanserin
Oral dose of ketanserin.
Other Name: Ketensin

Project 2
After baseline MRI & CIMBI-36 PET-imaging, participants will receive one dose of oral psilocybin. One and 12 weeks after dosing, participants will undergo post-intervention PET-scan.
Drug: Psilocybine
Oral dose of psilocybin.
Other Name: Psilocybin

Project 3
After baseline MRI scanning and CIMBI-36 PET, participants will undergo one psilocybin-intervention fMRI scan and one ketanserin-intervention fMRI scan. If P2 shows there are long term effects of psilocybin on 5-HT2AR levels, psilocybin will be fixed as the second intervention. If not, interventions will be randomized.
Drug: Psilocybine
Oral dose of psilocybin.
Other Name: Psilocybin

Drug: Ketanserin
Oral dose of ketanserin.
Other Name: Ketensin

Primary Outcome Measures :
  1. Psilocin/ketanserin blood concentrations and 5-HT2A receptor occupancy (i.e., binding potential). [ Time Frame: Change in Cimbi-36 binding potential from baseline PET to intervention PET 1 and PET 2 scans (same day for psilocybin, and two consecutive days for ketanserin). ]
    The investigators aim to model relations psilocin/ketanserin blood drug concentrations and receptor occupancy, using C11-Cimbi-36 PET imaging.

  2. Effects of psilocybin on Cimbi-36 binding potential at baseline and at one and twelve weeks [ Time Frame: Change in Cimbi-36 binding potential from baseline to one week post psilocybin (and potentially also at 12 weeks after psilocybin). ]
    Cimbi-36 PET scan binding potential at baseline and at one-week post psilocybin, and potentially also at 12 weeks post psilocybin.

  3. Effects of psilocybin and ketanserin on brain function assessed with fMRI [ Time Frame: Changes in functional connectivity (fMRI) from Baseline MR to intervention MR scans for ketanserin (one or three weeks after baseline MR) and psilocybin (one or three weeks after baseline) ]
    Correlations between blood levels of ketanserin and psilocin and the estimated associated receptor occupancy with functional MRI neuroimaging data, including resting state networks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

1) Healthy individuals above 18 years of age.

Exclusion Criteria:

  1. Presence of or previous primary psychiatric disease (DSM axis 1 or WHO ICD-10 diagnostic classifications) or in first-degree relatives.
  2. Previous or present neurological condition/disease, significant somatic condition/disease or intake of drugs suspected to influence test results.
  3. Non-fluent Danish language skills.
  4. Vision or hearing impairment.
  5. Previous or present learning disability.
  6. Pregnancy.
  7. Breastfeeding.
  8. Contraindications in regard to MRI scanning.
  9. Alcohol or drug abuse.
  10. Allergy to test drugs.
  11. Participation in studies in which participant has received more than 10 mSv of radiation or other significant exposure to radiation.
  12. Abnormal ECG or intake of QT prolonging medication.
  13. Previous significant side-effects in regard to hallucinogenic drugs.
  14. Use of hallucinogenic drugs 6 months previous to inclusion.
  15. Blood donation 3 months before and after project participation
  16. Bodyweight under 50 kg.
  17. Plasma ferritin levels outside normal range

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03289949

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Contact: Gitte M Knudsen, Professor +45 35456720
Contact: Martin K Madsen, MD +45 35456708

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Neurobiology Research Unit, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Gitte M Knudsen, Professor         
Sponsors and Collaborators
Gitte Moos Knudsen
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Study Chair: Gitte M Knudsen, Professor Neurobiology Research Unit, Rigshospitalet

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Responsible Party: Gitte Moos Knudsen, Professor, DMsc, MD, Rigshospitalet, Denmark Identifier: NCT03289949     History of Changes
Other Study ID Numbers: 2016-004000-61
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Via database of Center for Integrated Molecular Brain Imaging (Knudsen et al 2016, NeuroImage) data will be available for neuroscience research community contingent on approval by scientific board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Physiological Effects of Drugs
Psychotropic Drugs
Antihypertensive Agents
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action