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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03627117
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dominique de Quervain, MD, University of Basel

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Verum Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Randomized Placebo Controlled Cross-over Study Investigating the Influence of CBD on Episodic Memory in Healthy Subjects
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : December 8, 2018
Actual Study Completion Date : December 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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 Name: Cannabidinol (CBD) e-Liquid

Drug: Placebo
Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.
Other Name: 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 Name: Cannabidinol (CBD) e-Liquid

Drug: Placebo
Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.
Other Name: e-Liquid




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627117


Locations
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Switzerland
University of Basel, Division of Cognitive Neuroscience
Basel, Switzerland, 4055
Sponsors and Collaborators
Prof. Dominique de Quervain, MD
Investigators
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Study Chair: Janine Hotz Universität Basel, Birmannsgasse 8, CH-4055 Basel

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Responsible Party: Prof. Dominique de Quervain, MD, Prof. Dr. med., University of Basel
ClinicalTrials.gov Identifier: NCT03627117     History of Changes
Other Study ID Numbers: 2018-01125
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No