Influence of CBD on Episodic Memory in Healthy Subjects

Prof. Dominique de Quervain, MD39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

VerumDRUG

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

PlaceboDRUG

Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Basel, Division of Cognitive Neuroscience

Basel, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: Timepoint 21 minutes after first medication.

Secondary Outcomes

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.

Time frame: Timepoint 15 minutes after medication.

Data from ClinicalTrials.gov

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