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Active, not recruiting Early Phase 1

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

NCT05953038 · tracked via the Priya Life Science Denmark tracker
Phase
Early Phase 1
Started
2023-11-08
Last updated
2026-07-02

Condition(s) studied

Basic Science

Investigational drug(s) / intervention(s)

Lysergic Acid Diethylamide Tartrate →

Lysergic Acid Diethylamide Tartrate: D-Lysergic Acid Diethylamide (LSD) D-tartrate as oral drinking solution (water / ethanol 20% m/m)

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Plasma LSD - serotonin 2A receptor (5-HT2AR) occupancy relation — Within 24 hours following drug administration
    Occupancy will be estimated by comparing non-displaceable binding potential (BPND) values using baseline and intervention rescans as calculated using a simplified reference tissue model (SRTM). Occupancy values will be compared to plasma lysergic acid diethylamide (LSD) levels.

Trial sites (1)

FacilityCityRegionStatus
Neurobiology Research Unit, Rigshospitalet Copenhagen Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05953038 on ClinicalTrials.gov ↗ ← All trials in Denmark