Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT03289949

The Neurobiological Effect of 5-HT2AR Modulation

Led by Gitte Moos Knudsen · Updated on 2024-12-16

200

Participants Needed

1

Research Sites

691 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Neurobiological Effect of 5-HT2AR Modulation

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy individuals above 18 years of age
Not Eligible

You will not qualify if you...

  • Presence of or previous primary psychiatric disease (DSM axis 1 or WHO ICD-10 diagnostic classifications) or in first-degree relatives
  • Previous or present neurological condition/disease, significant somatic condition/disease or intake of drugs suspected to influence test results
  • Non-fluent Danish language skills
  • Vision or hearing impairment
  • Previous or present learning disability
  • Pregnancy
  • Breastfeeding
  • Contraindications in regard to MRI scanning
  • Alcohol or drug abuse
  • Allergy to test drugs
  • Participation in studies with more than 10 mSv radiation exposure
  • Abnormal ECG or intake of QT prolonging medication
  • Previous significant side-effects to hallucinogenic drugs
  • Use of hallucinogenic drugs 6 months before inclusion
  • Blood donation 3 months before and after participation
  • Body weight under 50 kg
  • Plasma ferritin levels outside normal range
  • Ethical concerns regarding psychedelic drug administration (for Subproject 2c specific exclusions)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Neurobiology Research Unit, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

G

Gitte M Knudsen, Professor

CONTACT

P

Patrick M Fisher, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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