Influence of CBD on Episodic Memory in Healthy Subjects
NCT ID: NCT03627117
Last Updated: 2020-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2018-08-13
2018-12-08
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Verum/Placebo
This group will start with CBD and after washout will receive placebo.
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.
Placebo/Verum
This group will start with placebo and will receive CBD after washout.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
30 Years
ALL
Yes
Sponsors
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Prof. Dominique de Quervain, MD
OTHER
Responsible Party
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Prof. Dominique de Quervain, MD
Prof. Dr. med.
Principal Investigators
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Janine Hotz
Role: STUDY_CHAIR
Universität Basel, Birmannsgasse 8, CH-4055 Basel
Locations
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University of Basel, Division of Cognitive Neuroscience
Basel, , Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-01125
Identifier Type: -
Identifier Source: org_study_id
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