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Placebo controlled, randomized, double blind, cross-over design.
Single vape of 0.25ml 5% CBD e-liquid (12.5mg CBD) and single vape of 0.25ml e-liquid, tastes like lemon and madeleine. 15min vape time each.
A total of 34 participants, equal number of male and female. There will be replacement of Drop-Outs until data from 34 participants are completed.
The primary endpoint will be performance in a verbal memory task. The secondary endpoint will be performance in a working memory test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum/Placebo | Experimental | This group will start with CBD and after washout will receive placebo. |
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| Placebo/Verum | Experimental | This group will start with placebo and will receive CBD after washout. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum | Drug | Single vape of 0.25mL of CBD e-Liquid containing: 5% CBD (low-temperature extracted Cannabidiol from Cannabis sativa L., purity 99%), Glycerine (vegetable), Propylene glycol, water |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal memory task | Three series of five semantically unrelated nouns will be presented. Total score is calculated by summing the number of correctly recalled words. Higher scores represent a better outcome. Score Minimum 0 and score maximum 15. | Timepoint 21 minutes after first medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Working memory | Working memory will be assessed by means of a letter 0-back and 2-back task (Papassotiropoulos et al., 2011). The 0-back condition serves as a low-load control condition, measuring general attention and does not require the manipulation of information within working memory. In the 2-back condition, participants have to compare the currently presented letter with the one presented 2 steps before and have to indicate whether they are identical or not. The 2-back condition requires online monitoring, updating and manipulation of remembered information and therefore is assumed to involve key processes of working memory. Accuracy and reaction time will be measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janine Hotz | Universität Basel, Birmannsgasse 8, CH-4055 Basel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel, Division of Cognitive Neuroscience | Basel | 4055 | Switzerland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2018 | Sep 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
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| Placebo | Drug | Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2. |
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| Timepoint 15 minutes after medication. |