Brain Imaging of Opioid Therapy
Research type
Research Study
Full title
Brain Imaging of Opioid Therapy in Individuals with Persistent Pain (BIOTIPP) – a double blind, randomized, placebo controlled crossover study
IRAS ID
132233
Contact name
Irene Tracey
Contact email
Sponsor organisation
University of Oxford
Research summary
Opioids or morphine-like medications are often used to relieve pain. However, the amount of pain relief afforded by opioids varies between people. Furthermore, tolerance to opioids develops over time for many people, which can limit the effectiveness of the medication for chronic pain. At the moment, long-term effects of opioids cannot be easily predicted in the individual person. In this research, we would explore the potential that MRI brain imaging has for deriving predictors of opioid effects in patients with chronic, non-cancer pain. Suitable patients may be those whose doctors are already planning to start strong opioids for pain relief. Participating patients would be enrolled in a short crossover study of placebo and morphine treatments, each lasting for 2 weeks. Standardized and validated questionnaires would be used to record the effects of the treatments. Brain responses to mild heat pain under remifentanil, an ultra-short acting intravenous opioid, would be measured to provide objective indicators of opioid tolerance. Blood tests would be performed to measure opioid medication levels and sex hormones because these influence brain responses to pain. After which, patients may be prescribed strong opioids by the doctor. All patients would be followed up for their clinical outcomes by the researchers for up to one year. Data from MRI brain scanning and other scientific measures of opioid effects would be generated for each patient during the crossover trial. These data would be analyzed to identify potential predictors of the clinical effectiveness of opioids for chronic pain. General Practices within the Thames Valley Comprehensive Local Research Network would serve as patient identification centres. The study itself would be based at the Oxford University Centre for the Functional Magnetic Resonance Imaging of the Brain, which is based at John Radcliffe Hospital (Oxford, United Kingdom). Funding from the study comes from an academic-led investigational grant from Grunenthal, as well as the Oxford NIHR Biomedical Research Centre.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/0001
Date of REC Opinion
19 Feb 2014
REC opinion
Further Information Favourable Opinion