Healthy
Conditions
Brief summary
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.
Interventions
DRUGVerum
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
DRUGPlacebo
Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.
Sponsors
Prof. Dominique de Quervain, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Normotensive (BP between 90/60mmHg and 140/90mmHg) * BMI between 18 and 30 kg/m2 * Male or female * Aged between 18 and 30 years * Native or fluent German-speaking * Able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol * Willing to donate urine sample to control for pre-Visit CBD/THC consume
Exclusion criteria
* Acute or chronic psychiatric disorder including drug or alcohol abuse * Women who are pregnant or breast feeding * Intention to become pregnant during the course of the study * Smoking (\> 5 cigarettes per day) * Participation in one of our previous studies using the same verbal test in the past 2 years * Participation in a study with CBD / THC within the 30 days preceding and during the present study * Known hypersensitivity or allergy to propylene glycol * Intake of CBD / THC within the 7 days preceding and during the present study in any application form * Long-term systemic medication or topical steroids to treat an underlying disease within last 3 months * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Enrolment of the investigator, his/her family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal memory task | Timepoint 21 minutes after first medication. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Working memory | Timepoint 15 minutes after medication. | 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. |
Countries
Switzerland
Outcome results
None listed