Healthy Volunteers, Modeling Psychosis
Conditions
Keywords
delta-9-tetrahydrocannabinol, cannabidiol, COMT
Brief summary
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.
Interventions
oral administration of delta-9-tetrahydrocannabinol
DRUGCannabidiol
oral administration of cannabidiol
DRUGPlacebo
oral administration of placebo
Sponsors
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent given by the subject * Healthy young man (age between 18 and 45) insightful to the study (WST\> 95) * Right handedness * At least one time consumption of Cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse * Negative drug-screening at the time of screening * Body Mass Index between 18 and 30
Exclusion criteria
* Lack of accountability * Participation in other interventional trials * Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator * Any known psychiatric illness in the participant's history * Known family history concerning psychiatric disorders * Cannabis consumption within the last six months * Consumption of any illegal drugs (except cannabis in history, see above) * Intake of interfering medication, at the discretion of the investigator * High intracranial pressure * Any disorders in stereoscopic vision (measured by the TNO-Test, Lamerics, Utrecht) or hearing deficits * Contraindications due to the Investigators Brochure Contraindication for Magnetic Resonance Imaging (e.g. cardiac pacemaker, claustrophobia, attached brace, in body metal, tattoos) or lumbar puncture (e.g. local or systemic infection, disturbance of blood coagulation, medication with anticoagulants like Phenprocoumon) or contradiction for the PET-CT method and the radiopharmaceutical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | up to 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PANSS subscores and clusters (baseline to post drug intake) | up to 4 hours | — |
| Change in Digit Symbol Coding | up to 6 hours | — |
| Change in Letter-Number-Sequencing | up to 6 hours | — |
| Change in emotional state (EWL, Eigenschaftswörterliste) | up to 6 hours | — |
| Change in attentional state (d2-test of attention d2-R) | up to 6 hours | — |
| Change in imagination (Bett's Questionaire upon Mental Imagery) | up to 6 hours | — |
| Change in Wisconsin Card Sorting Test Performance | up to 6 hours | — |
| Assessment of hallucinogenic states scale (APZ) (post drug intake) | 1 day | questionaire |
| 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 | 1 day | — |
| Metabolic markers post drug intake (blood) | up to 4 hours | — |
| Metabolic markers post drug intake (cerebrospinal fluid) | up to 4 hours | — |
| D2-receptor availability post drug intake | up to 5 hours | — |
| Change in binocular depth inversion illusion (BDII) | up to 6 hours | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of biomarker profiles in serum and cerebrospinal fluid of subjects | 1 day | Comparison of biomarker profiles in serum and cerebrospinal fluid after different treatments |
Countries
Germany
Outcome results
None listed