The effect of Cannabidiol (CBD) on paranoid cognitions in humans
| ISRCTN | ISRCTN11082858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11082858 |
| Secondary identifying numbers | 3.2d30.5.13 |
- Submission date
- 11/07/2013
- Registration date
- 16/08/2013
- Last edited
- 02/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The aim of this study is to find out about the effect of Cannabidiol (CBD) on brain function. CBD comes from the cannabis plant, but does not produce a 'high' as its effects in humans are almost undetectable except for mild sedation at high doses. The researchers want to learn more about the effect of CBD on the human mind in a simulated version of everyday life.
Who can participate?
People who are currently attending the OASIS clinic who are not currently taking any psychiatric mediation, aged between 18 and 50, who are physically well, with no history of major illness.
What does the study involve?
The study involves two blocks of 5 days each. On day 1 of each block participants are given a capsule containing either CBD or placebo (dummy) in a random order. They are then given a box containing the remaining doses, and are asked to take a dose of CBD in the evenings for the next 3 days. On the 5th day of each block participants have the experimental session, where a small blood sample is taken to test how much CBD is in their body. They are then be asked to complete some questionnaires and finally complete the virtual-reality bus ride, followed by a simulated public-speaking task. Their heart rate is measured and small saliva samples are taken. The CBD week results are compared with the placebo week results.
What are the possible benefits and risks of participating?
Participants are paid £28 per day they are involved in the study, which is 10 days in total giving a maximum of £280. They are collected from home by taxi and dropped back home at the end of each day. Some people may experience mild sedation after taking CBD, so participants are asked not to drive, operate heavy machinery or engage in hazardous activities during the days they take any capsules. There are no documented effects of CBD on the heart or the nervous system aside from mild sedation, and no adverse effects have been recorded. It can very occasionally happen that some people experience a degree of nausea or disturbances in their vision after being in the virtual reality. Therefore if at any time they wish to stop, they can stop immediately.
Where is the study run from?
Institute of Psychiatry, King's College London (UK)
When is study starting and how long is it expected to run for?
July 2013 to August 2015
Who is funding the study?
The study is funded by an unrestricted grant from GW Pharma (UK)
Who is the main contact?
Dr Paul Morrison
paul.morrison@kcl.ac.uk
Contact information
Scientific
M5.06.02 Psychosis Studies
5th Floor, Main Building
Institute of Psychiatry
16 DeCrespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)207 848 0057 |
|---|---|
| paul.morrison@kcl.ac.uk |
Study information
| Study design | Randomised cross-over design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The effect of Cannabidiol (CBD) on paranoid cognitions in humans: a randomised controlled trial |
| Study acronym | CBD VR2 |
| Study objectives | CBD decreases perceived social threat and their endocrine sequelae. |
| Ethics approval(s) | National Research Ethics Service (NRES) Committee London, 30/05/2013 |
| Health condition(s) or problem(s) studied | Paranoid cognitions |
| Intervention | All participants will receive Cannabidiol (CBD) on one occasion, and placebo on the other. The order of administrations will be randomised and double-blinded. The drugs will be administered as oral capsules, 3 x 100 mg being taken twice a day (total dose per day is 600 mg). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cannabidiol |
| Primary outcome measure | 1. Autonomic arousal using pulse and respiratory rates and saliva swabs to measure cortisol 2. Paranoid thinking using the State-Social Paranoid Scale and the Cape-(state version) 3. Affective processing using the Beck Anxiety Inventory, the Bond and Lader Visual Analogue Scale and the Negative-Self-Statement-Scale |
| Secondary outcome measures | Cognitive functioning using the Letter-Number-Span to measure working memory, and the Hopkins-Verbal-Learning-Task-Revised |
| Overall study start date | 22/07/2013 |
| Completion date | 22/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Aged 18-50 years 2. English as first language 3. Patient at OASIS service |
| Key exclusion criteria | 1. Subjects who have been diagnosed with a major mental or physical illness (epilepsy, schizophrenia, bipolar disorder) 2. Subjects must not have had previous treatment with antipsychotic or mood stabilising drugs 3. Pregnancy 4. Drug/alcohol dependence |
| Date of first enrolment | 22/07/2013 |
| Date of final enrolment | 01/01/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE5 8AF
United Kingdom
Sponsor information
University/education
Institute of Psychiatry
16 DeCrespigny Park
London
SE5 8AF
England
United Kingdom
| Website | http://www.kcl.ac.uk/iop/index.aspx |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/09/2020: No publications found.
18/09/2017: No publications found, verifying study status with principal investigator.
