RecruitingPhase 1NCT03289949

The Neurobiological Effect of 5-HT2AR Modulation


Sponsor

Gitte Moos Knudsen

Enrollment

200 participants

Start Date

Mar 3, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • \) Healthy individuals above 18 years of age.

Exclusion Criteria32

  • 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 in which participant has received more than 10 mSv of radiation or other significant exposure to radiation.
  • Abnormal ECG or intake of QT prolonging medication.
  • Previous significant side-effects in regard to hallucinogenic drugs.
  • Use of hallucinogenic drugs 6 months previous to inclusion.
  • Blood donation 3 months before and after project participation
  • Body weight under 50 kg.
  • Plasma ferritin levels outside normal range
  • Presence of or previous primary psychiatric disease (DSM IV axis 1 or WHO ICD-10 diagnostic classifications).
  • 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).
  • Previous or present neurological condition/disease, significant somatic condition/disease or intake of drugs suspected to influence test results.
  • Non-fluent Danish language skills or pronounced 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.
  • Abnormal ECG or intake of QT prolonging medication.
  • Previous significant side-effects in regard to hallucinogenic drugs.
  • Previous use of hallucinogenic drugs.
  • Body weight under 45 kg.
  • Ethical concerns regarding the administration of a psychedelic drug.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPsilocybine

Oral dose of psilocybine.

DRUGKetanserin

Oral dose of ketanserin.


Locations(1)

Neurobiology Research Unit, Rigshospitalet

Copenhagen, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03289949


Related Trials