Influence of CBD on Episodic Memory in Healthy Subjects

NCT ID: NCT03627117

Last Updated: 2020-09-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2018-12-08

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Verum/Placebo

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

Group Type EXPERIMENTAL

Verum

Intervention Type 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

Placebo

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Verum

Intervention Type 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

Placebo

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Cannabidinol (CBD) e-Liquid e-Liquid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prof. Dominique de Quervain, MD

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dominique de Quervain, MD

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Switzerland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018-01125

Identifier Type: -

Identifier Source: org_study_id

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