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Completed

NCT Number: NCT03627117

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.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel, Division of Cognitive Neuroscience

Basel, 4055, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Cannabidinol (CBD) e-Liquid

Placebo

Drug

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

Other names: e-Liquid

Primary outcomes

  1. Verbal memory task

    Time frame: Timepoint 21 minutes after first medication.

    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.

Secondary outcomes

  1. Working memory

    Time frame: Timepoint 15 minutes after medication.

    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.

Sponsors and collaborators

Lead sponsor

Prof. Dominique de Quervain, MD

Other

Registry information

Official study title

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

Acronym: CoIL-Basel

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2018
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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