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Active Not Recruiting NCT05953038

LSD Occupancy of the Serotonin 2A Receptor in the Human Brain

Conditions: Basic Science

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 40
Sponsor: Rigshospitalet, Denmark

Location: Neurobiology Research Unit, Rigshospitalet Copenhagen

Summary

The investigators wish to quantify the relation between administered dose of lysergic acid diethylamide (LSD), plasma LSD levels, and occupancy at the serotonin 2A receptor (5-HT2AR) using \[11C\]CIMBI-36 positron emission tomography.

Eligibility Criteria

Inclusion Criteria: • Healthy individual between 18-75 years old Exclusion Criteria: * Current or past history of primary psychiatric illness (The Diagnostic and Statistical Manual of Mental Disorders IV axis-I or World Health Organisation International Classification of Diseases-10 diagnostic classification) * Current or past history of primary psychiatric illness (The Diagnostic and Statistical Manual of Mental Disorders IV axis-I or World Health Organisation International Classification of Diseases-10 diagnostic classification) in a first degree relative (i.e., parents, siblings) * Current or past history of neurological disease, significant somatic condition/disease * Use of medication that could potentially influence results (e.g.., drugs that act on relevant components of the serotonin system or may interfere with metabolism of study drug) * Non-fluent Danish language skills * Profound visual or auditory impairments * Severe learning disability * Pregnancy on the scan date, verified by a pregnancy test (test omitted if confirmed that individual is post-menopausal) * Lactation (females) * Contraindications for magnetic resonance imaging (e.g., pacemaker, claustrophobia, etc.) * Contraindications for positron emission tomography * Alcohol or drug abuse * Allergy to administered compounds * Participant in research study with \>10 millisievert exposure within the past year or significant occupational exposure to radioactive substances * Abnormal ECG (ECG indicating current or previous heart disease or predisposition to heart disease, e.g., QT prolongation) or use of QT prolonging medication * Use of psychedelic substance within the preceding six months * Blood donation up to three months before the study (i.e., more than 500ml of blood) * Head injury or concussion resulting in loss of consciousness for more than 2 min * Haemoglobin levels \< 7.8 mmol/l for women and 8.4 mmol/l for men * Ferritin levels outside normal range (12-300 µg/L) * Body-weight \< 50 kg or \> 110kg * body-mass index \> 35 * Individual assessment by research staff deeming drug administration unsafe due to ethical or psychological circumstance of the participant

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Source: ClinicalTrials.gov (NCT05953038). StuddyBuddy aggregates publicly available trial information.