Influence of CBD on Episodic Memory in Healthy Subjects

Healthy Clinical Trial

— CoIL-Basel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627117
• Other study ID #: 2018-01125
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: December 8, 2018

Study information

• Verified date: September 2020
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 8, 2018
• Est. primary completion date: December 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Switzerland	University of Basel, Division of Cognitive Neuroscience	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.