Influence of CBD on Episodic Memory in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Placebo Controlled Cross-over Study Investigating the Influence of CBD on Episodic Memory in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Verum
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum/Placebo<br>This group will start with CBD and after washout will receive placebo. | Drug: Verum<br>* 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<br>* Other names: Cannabidinol (CBD) e-Liquid;Drug: Placebo<br>* Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.<br>* Other names: e-Liquid;|
| Experimental: Placebo/Verum<br>This group will start with placebo and will receive CBD after washout. | Drug: Verum<br>* 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<br>* Other names: Cannabidinol (CBD) e-Liquid;Drug: Placebo<br>* Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.<br>* Other names: e-Liquid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | Timepoint 15 minutes after medication. |