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Active, not recruitingEarly Phase 1

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

NCT05953038 · dOccLS · Rigshospitalet, Denmark

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
40
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Plasma LSD - serotonin 2A receptor (5-HT2AR) occupancy relation

    Measured over Within 24 hours following drug administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 75 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Neurobiology Research Unit, RigshospitaletCopenhagenDenmark

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05953038 on ClinicalTrials.gov →

Last updated in the registry 2026-07-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication