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

Prof. Dominique de Quervain, MD

Status: Completed

Conditions: Healthy

Treatments: Drug: Verum; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03627117

2018-01125

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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39 participants in 2 patient groups

Verum/Placebo

Experimental group

Description:

This group will start with CBD and after washout will receive placebo.

Treatment:

Drug: Placebo

Drug: Verum

Placebo/Verum

Experimental group

Description:

This group will start with placebo and will receive CBD after washout.

Treatment:

Drug: Placebo

Drug: Verum