HealthyCoIL-BaselNCT03627117
Influence of CBD on Episodic Memory in Healthy Subjects
A study testing Verum in people with Healthy, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Verum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Aug 2018to 8 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Division of Cognitive Neuroscience
Basel, 4055
About this study
Official title: Randomized Placebo Controlled Cross-over Study Investigating the 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.
- Conditions
- Healthy
- Being tested
- Verum, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerumDrug
Also called Cannabidinol (CBD) e-Liquid
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
PlaceboDrug
Also called e-Liquid
Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.
| Study group | Role | What they receive |
|---|---|---|
| Verum/Placebo | Experimental | This group will start with CBD and after washout will receive placebo. Receives: Drug: Verum; Drug: Placebo |
| Placebo/Verum | Experimental | This group will start with placebo and will receive CBD after washout. Receives: Drug: Verum; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal memory task
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.
Measured: Timepoint 21 minutes after first medication.
Secondary outcomes (1)
Working memory
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.
Measured: Timepoint 15 minutes after medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start13 Aug 2018
- Primary completion8 Dec 2018
- Study completion8 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Janine Hotz, Study chair, Universität Basel, Birmannsgasse 8, CH-4055 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627117
- Sponsor's protocol ID
- 2018-01125
- Other IDs
- 2018
- Acronym
- CoIL-Basel
- Status last verified
- Sep 2020
- First submitted
- 11 Jul 2018
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo Controlled Cross-over Study Investigating the Influence of CBD on Episodic Memory in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03627117
- Acronym / sponsor ID
- CoIL-Basel / 2018-01125
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum/Placebo | Experimental | Drug: Verum, Drug: PlaceboThis group will start with CBD and after washout will receive placebo. |
| Placebo/Verum | Experimental | Drug: Verum, Drug: PlaceboThis group will start with placebo and will receive CBD after washout. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerumAlso: Cannabidinol (CBD) e-LiquidSingle 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 | Drug | Placebo/Verum, Verum/Placebo |
| PlaceboAlso: e-LiquidSingle vape of 0.25ml e-liquid La Baronne Jaune, BORDO2. | Drug | Placebo/Verum, Verum/Placebo |
Primary outcome
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.
1 secondary outcome
Working memory
Time frame: Timepoint 15 minutes after medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janine Hotz study chair
Universität Basel, Birmannsgasse 8, CH-4055 Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum in people with Healthy, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal memory task (time frame: Timepoint 21 minutes after first medication.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.