Contact information
Type
Scientific
Primary contact
Dr Robert David Rogers
ORCID ID
Contact details
Department of Psychiatry
University of Oxford
Warneford Hospital
Headington
Oxford
OX3 7JX
United Kingdom
+44 (0)1865 226399
robert.rogers@psych.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176131698
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/11/2003
Overall trial end date
31/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Healthy volunteer
Age group
Not Specified
Gender
Not Specified
Target number of participants
15 healthy people
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2003
Recruitment end date
31/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Oxford
OX3 7JX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Oxford Radcliffe Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary