NCT03289949 The Neurobiological Effect of 5-HT2AR Modulation
| NCT ID | NCT03289949 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Gitte Moos Knudsen |
| Condition | Basic Science |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2017-03-03 |
| Primary Completion | 2030-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2017-03-03 with a primary completion date of 2030-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1\) Healthy individuals above 18 years of age. Exclusion Criteria (For Subprojects 1, 2a, 2b, and 3): 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. Body weight under 50 kg. 17. Plasma ferritin levels outside normal range Exclusion Criteria (For Subproject 2c): 1. Presence of or previous primary psychiatric disease (DSM IV axis 1 or WHO ICD-10 diagnostic classifications). 2. Presence of or previous primary psychiatric disease with psychosis symptoms or hypomania (DSM IV axis 1 \[drug/alcohol abuse/dependence, schizophrenia and other psychoses\] or WHO ICD-10 diagnostic classifications \[F10-29, as well as F30-39 with psychotic symptoms, F60\]) in first-degree relatives (parents or siblings). 3. Previous or present neurological condition/disease, significant somatic condition/disease or intake of drugs suspected to influence test results. 4. Non-fluent Danish language skills or pronounced 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. Abnormal ECG or intake of QT prolonging medication. 12. Previous significant side-effects in regard to hallucinogenic drugs. 13. Previous use of hallucinogenic drugs. 14. Body weight under 45 kg. 15. Ethical concerns regarding the administration of a psychedelic drug.
Contact & Investigator
Gitte M Knudsen, Professor
STUDY CHAIR
Neurobiology Research Unit, Rigshospitalet
Frequently Asked Questions
Who can join the NCT03289949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Basic Science. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03289949 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03289949 currently recruiting?
Yes, NCT03289949 is actively recruiting participants. Contact the research team at gmk@nru.dk for enrollment information.
Where is the NCT03289949 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT03289949 clinical trial?
NCT03289949 is sponsored by Gitte Moos Knudsen. The principal investigator is Gitte M Knudsen, Professor at Neurobiology Research Unit, Rigshospitalet. The trial plans to enroll 200 participants.