Influence of CBD on Episodic Memory in Healthy Subjects

NCT03627117 | Completed

• 1 other identifier: 2018-01125
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Working memory

  Timepoint 15 minutes after medication.

Study Arms (2)

Verum/Placebo

EXPERIMENTAL

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

Drug: Verum; Drug: Placebo

Placebo/Verum

EXPERIMENTAL

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

Drug: Verum; Drug: Placebo

Interventions

Verum DRUG

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

Also known as: Cannabidinol (CBD) e-Liquid

Placebo/Verum; Verum/Placebo

Placebo DRUG

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

Also known as: e-Liquid

Placebo/Verum; Verum/Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, 4055, Switzerland

Location

MeSH Terms

Interventions

calcium D-pantothenate, L-cysteine drug combination

Study Officials

• Janine Hotz

  Universität Basel, Birmannsgasse 8, CH-4055 Basel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 13, 2018
• Study Start: August 13, 2018
• Primary Completion: December 8, 2018
• Study Completion: December 8, 2018
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)