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

P

Prof. Dominique de Quervain, MD

Status

Completed

Conditions

Healthy

Treatments

Drug: Verum
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03627117
2018-01125

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

39 participants in 2 patient groups

Verum/Placebo
Experimental group
Description:
This group will start with CBD and after washout will receive placebo.
Treatment:
Drug: Placebo
Drug: Verum
Placebo/Verum
Experimental group
Description:
This group will start with placebo and will receive CBD after washout.
Treatment:
Drug: Placebo
Drug: Verum

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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