A functional magnetic imaging (fMRI) study of the effects of cannabis-based medicines (CMEs) on the neutral activity associated with noxious thermal stimulation in healthy human volunteers (CRI.FM024). Protocol V2. FINAL
| ISRCTN | ISRCTN58754671 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58754671 |
| Secondary identifying numbers | N0176131698 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert David Rogers
Scientific
Scientific
Department of Psychiatry
University of Oxford
Warneford Hospital
Headington
Oxford
OX3 7JX
United Kingdom
| Phone | +44 (0)1865 226399 |
|---|---|
| robert.rogers@psych.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A functional magnetic imaging (fMRI) study of the effects of cannabis-based medicines (CMEs) on the neutral activity associated with noxious thermal stimulation in healthy human volunteers (CRI.FM024). Protocol V2. FINAL |
| Study objectives | We wish to undertake an experimental study of the effects of cannabis-based medicines (CMEs) on the neutral activity associated with the experience of pain in healthy volunteer participants. Fifteen volunteers will complete an fMRI scanning protocol on 4 separate study days on each of which they will receive one of 3 CMEs or a placebo treatment. During the scanning protocol, volunteers will receive noxious thermal stimulation on the dorsum of the left hand. Differences in volunteers' ratings of the intensity of the pain experience, as well as differences in measures of neutral activity associated with this experience, will provide important new information about CMEs' putative analgesia and their underlying mechanisms. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sign and Symptoms: Pain |
| Intervention | 15 volunteers will complete an fMRI scanning protocol on 4 separate study days on each of which they will receive one of 3 CMEs or a placebo treatment. During the scanning protocol, volunteers will receive noxious thermal stimulation on the dorsum of the left hand. |
| Intervention type | Other |
| Primary outcome measure | 1. Volunteers' rating of pain during noxious thermal stimulation 2. BOLD response associated with thermal stimulation after the 3 CMEs treatments and the placebo treatment sessions. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2003 |
| Completion date | 31/10/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 15 healthy people |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 31/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Oxford
Oxford
OX3 7JX
United Kingdom
OX3 7JX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
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
02/11/2016: No publications found, verifying study status with principal investigator.
