Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids - a PET Study
Phase 1
Withdrawn
- Conditions
- Modeling PsychosisHealthy Volunteers
- Interventions
- Registration Number
- NCT02492074
- Lead Sponsor
- Central Institute of Mental Health, Mannheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description THC Placebo Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules. CBD Placebo Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules. Placebo Placebo Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules CBD Cannabidiol Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules. THC Delta-9-tetrahydrocannabinol Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules. CBD+THC Cannabidiol Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) CBD+THC Delta-9-tetrahydrocannabinol Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in PANSS subscores and clusters (baseline to post drug intake) up to 4 hours Change in Digit Symbol Coding up to 6 hours Metabolic markers post drug intake (blood) up to 4 hours Metabolic markers post drug intake (cerebrospinal fluid) up to 4 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 binocular depth inversion illusion (BDII) 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 D2-receptor availability post drug intake up to 5 hours
Trial Locations
- Locations (1)
Central Institute of Mental Health
🇩🇪Mannheim, BW, Germany