Active, not recruiting
Early Phase 1
LSD Occupancy of the Serotonin 2A Receptor in the Human Brain
Condition(s) studied
Basic Science
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| Neurobiology Research Unit, Rigshospitalet |
Copenhagen |
Denmark |
|
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