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, neuronal processing assessed by fMRI as well as D2-receptor availability assessed by \[18F\] desmethoxyfallypride.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
oral administration of delta-9-tetrahydrocannabinol
oral administration of cannabidiol
oral administration of placebo
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 D2-receptor availability
Time frame: up to 6 hours
Change in PANSS subscores and clusters (baseline to post drug intake)
Time frame: up to 4 hours
Change in Digit Symbol Coding
Time frame: up to 6 hours
Change in Letter-Number-Sequencing
Time frame: up to 6 hours
Change in emotional state (EWL, "Eigenschaftswörterliste")
Time frame: up to 6 hours
Change in attentional state (d2-test of attention d2-R)
Time frame: up to 6 hours
Change in imagination (Bett's Questionaire upon Mental Imagery)
Time frame: up to 6 hours
Change in binocular depth inversion illusion (BDII)
Time frame: up to 6 hours
Change in Wisconsin Card Sorting Test Performance
Time frame: up to 6 hours
Assessment of hallucinogenic states scale (APZ) (post drug intake)
questionaire
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
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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
D2-receptor availability post drug intake
Time frame: up to 5 hours