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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, neural synchrony and neuronal processing assessed by EEG and fMRI.
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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. |
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| 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) a |
|
| 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 |
|
| |
| Cannabidiol |
| 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 neural synchrony. | up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) subscores and clusters (baseline to post drug intake) | up to 4 hours | |
| Change in neuropsychological parameters | up to 6 hours | |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of biomarker profiles in serum and cerebrospinal fluid of subjects. | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Institute of Mental Health | Mannheim | Baden-Wurttemberg | 68159 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33304282 | Derived | Woelfl T, Rohleder C, Mueller JK, Lange B, Reuter A, Schmidt AM, Koethe D, Hellmich M, Leweke FM. Effects of Cannabidiol and Delta-9-Tetrahydrocannabinol on Emotion, Cognition, and Attention: A Double-Blind, Placebo-Controlled, Randomized Experimental Trial in Healthy Volunteers. Front Psychiatry. 2020 Nov 13;11:576877. doi: 10.3389/fpsyt.2020.576877. eCollection 2020. |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Drug |
|
| Placebo | Drug |
|
| Assessment of hallucinogen states (APZ) (post drug intake) |
| 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 |
| Neural synchrony and event-related potentials post drug intake | up to 5 hours |