An fMRI study in healthy volunteers to investigate the effects of a new medication for pain on experimental hyperalgesia and its neural correlates.
REC Ref: 16/SC/0404
Version 1.0, 28th February 2017
Chief Investigator: Professor Irene Tracey, Oxford Centre for functional MRI of the Brain, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford, OX3 9DU.
Study Sponsor: Abide Therapeutics
What is the purpose of the research?
You are being invited to take part in a clinical research study to evaluate an investigational drug for the treatment of pain. An investigational drug is a medicinal product that is still being studied to evaluate its efficacy, safety or mode of action. The health authorities have not approved this investigational drug for use in patients. This study will investigate what happens in the brain when the drug is given, and whether this brain activity is consistent with a painkilling effect.
Am I eligible to take part?
We are looking for healthy right-handed men, aged 18-55, who speak fluent English and are not on any medications. If you decide that you would like to take part, a member of the research team will go through the eligibility criteria with you in more detail.
What will the study involve?
The study involves 5 visits to the John Radcliffe hospital in Oxford:
Visit 1: The first visit is a screening visit during which we will check that you are eligible to take part in the rest of the study. It lasts about 5 hours. During this time we will examine you, ask you some questions, and do some blood and urine tests. We will also do an ECG (electrical recording of your heart). You will complete a short MRI brain scan, and we will test how you respond to capsaicin cream on your leg. Capsaicin is the substance that makes chilli peppers hot, and it can produce a temporary burning sensation.
Visits 2-4: These are the treatment visits. On one of the visits you will receive a dose of the investigational medication, on another of the visits you will receive a placebo pill, and on the remaining visit you will not take anything at all. You will then have capsaicin cream applied to your leg for about an hour, after which you will have an MRI scan of your brain. For a small period of the scan, a researcher will test whether or not it is painful to touch the area around the cream using a special touch probe. During this visit we will take blood and urine samples, ECGs, and will ask you to answer some questionnaires. This will all take up to around 8 hours, but there will be some gaps during this time, so we recommend that you bring a book.
On the visits in which you receive the investigational medication or placebo, we ask you to stay with us overnight in a private ensuite room. There will be no study activities to perform overnight, and you will be free to get on with your own work/reading/entertainment etc., but a nurse will be on hand in the unlikely event that you feel unwell. In the morning a member of the research team will assess you before you go home.
Visit 5: This is a follow-up visit lasting 1-2 hours. You will be examined by a doctor, asked some questions about any changes that may have taken place since we last saw you, and we will do some final blood tests.
Will I be reimbursed for my time?
Yes. You will be reimbursed £100 for visit 1, £200 for each visit in which you receive the investigational medication or placebo, £100 for the no treatment visit, and £50 for the follow-up visit. The maximum reimbursement if you complete the whole study is £650.
What restrictions would apply if I take part?
If you decide to take part in the study, we would ask that you follow these guidelines:
- Not to eat or drink anything except water for 8 hours prior to arriving for visits 2-4.
- Not to use any recreational drugs during the study
- Not to take part in any other clinical study involving an investigational treatment whilst you are participating in this study.
- Not to use any prescription medications or over-the-counter medications or dietary supplements during the study unless absolutely necessary, and to inform the research team if this is the case.
- If you are a smoker, not to smoke more than 4 cigarettes per day during the study. In addition, you will need to abstain from smoking and nicotine containing products during each study visit.
- Not to consume excessive amounts of alcohol or caffeinated beverages, and to adhere to any specific restrictions given during the study.
- Not to eat grapefruit or drink grapefruit juice at all during the study.
- Not to take up any new strenuous exercise during the study (you can continue with anything that you do already).
- To use a condom with female partners during the study and for 3 months afterwards.
We will go through all of this with you in more detail if you decide that you might like to take part.
Do I have to take part?
No. It is up to you to decide if you want to take part in this study, and you can withdraw at any time.
I’d like to take part or I have further questions. What do I do next?
Email team members Dean Fido (firstname.lastname@example.org) or Sarah Waldman (email@example.com). Alternatively give them a call on 01865 222725. They will be happy to answer any questions that you have. If you’d like to take part, they will give you some more information about the study, and will arrange a time to speak to you on the phone in order run through the study in details and to check that you are eligible to take part.