The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal processing assessed by EEG and fMRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
60
Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, Germany
Change in Positive and Negative Syndrome Scale total score (PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural synchrony.
Time frame: up to 4 hours
Change in Positive and Negative Syndrome Scale (PANSS) subscores and clusters (baseline to post drug intake)
Time frame: up to 4 hours
Change in neuropsychological parameters
Time frame: up to 6 hours
Assessment of hallucinogen states (APZ) (post drug intake)
Time frame: 1 day
Safety and tolerability assessments including (S)AEs, physical examination, vital signs (including heart rate and systolic and diastolic blood pressure in both supine and standing positions), and detailed laboratory assessments
Time frame: 1 day
Metabolic markers post drug intake (blood)
Time frame: up to 4 hours
Metabolic markers post drug intake (cerebrospinal fluid)
Time frame: up to 4 hours
Neural synchrony and event-related potentials post drug intake
Time frame: up to 5 hours
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