Influence of CBD on Episodic Memory in Healthy Subjects (CoIL-Basel)

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Verum; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • University of Basel, Division of Cognitive Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Prof. Dominique de Quervain, MD
• Investigators: Study Chair: Janine Hotz, Universität Basel, Birmannsgasse 8, CH-4055 Basel

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): December 8, 2018
• Study Completion (Actual): December 8, 2018

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018-01125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No