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ISRCTN
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ISRCTN58754671
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0176131698
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Sign and Symptoms: Pain
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/11/2003
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Anticipated end date
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31/10/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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15 healthy people
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Interventions
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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.
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Primary outcome measure(s)
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The dependent measures will be:
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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Oxford Radcliffe Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Robert David
Rogers
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Address
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Department of Psychiatry
University of Oxford
Warneford Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7JX
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Country
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United Kingdom
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Tel
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+44 (0)1865 226399
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Fax
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+44 (0)1865 713101
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Email
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robert.rogers@psych.ox.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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06/04/2011
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Date ISRCTN assigned
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30/09/2004
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