NCT05953038

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

Lysergic Acid Diethylamide Occupancy of the Serotonin 2A Receptor in the Human Brain

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Healthy participants will be administered one of a single dose of lysergic acid diethylamide (LSD) between 25 and 200 micrograms equivalent freebase. They will receive \[11C\]CIMBI-36 positron emission tomography (PET) scans at baseline and twice following LSD administration during peak and declining drug effects. PET scans will be acquired in a simultaneous PET/Magnetic Resonance Imaging (MRI) scanner which will also collect functional brain imaging data. Venous blood samples will be repeatedly drawn during acute drug effects for quantification of plasma LSD levels. Participants will also repeatedly rate their subjective drug intensity on a scale from 0 to 10 during acute drug effects. Together these data will inform the dose-binding relation of LSD at the serotonin (5-HT) 2A receptor, the primary site of action. This data will also inform the relation between 5-HT2A receptor binding by LSD and the induced subjective effects, as well as the effects on functional brain activity as measured with functional MRI.

Conditions

• Basic Science

Interventions

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

Timeline

• Start date: 2023-11-08
• Primary completion: 2027-12-18
• Completion: 2027-12-31
• First posted: 2023-07-19
• Last updated: 2024-12-18

Locations

1 site across 1 country: Denmark