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No documents were ever submitted to the Ethics Committee or the competent authority because it was not possible to establish the planned PET measurements in Germany. Therefore, the study never started.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THC | Experimental | Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules. |
|
| CBD | Experimental | Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules. |
|
| CBD+THC | Experimental | Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) |
|
| Placebo | Placebo Comparator | Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta-9-tetrahydrocannabinol | Drug | oral administration of delta-9-tetrahydrocannabinol |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of biomarker profiles in serum and cerebrospinal fluid of subjects | Comparison of biomarker profiles in serum and cerebrospinal fluid after different treatments | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| F. Markus Leweke, MD | Central Institute of Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Institute of Mental Health | Mannheim | Baden-Wurttemberg | 68159 | Germany |
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| Cannabidiol | Drug | oral administration of cannabidiol |
|
| Placebo | Drug | oral administration of placebo |
|
| 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) | questionaire | 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 | 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 |
| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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