Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
02/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

02/11/2016: No publications found, verifying study status with principal investigator.