Not yet recruitingPHASE2INTERVENTIONAL

Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial

This study is investigating if modafinil, a drug known to help with sleepiness, could reduce the common and often severe tiredness experienced by people with Crohn's disease (CD) or ulcerative colitis (UC). Many people with these conditions feel tired even when their illness is under control, and there aren't many effective treatments for this specific type of fatigue. This is a 'feasibility' study, which means its main goal is to test if a larger study on modafinil for IBD fatigue is possible to do. Participants will receive either modafinil or a dummy pill for 12 weeks. Researchers will monitor how many people join, complete the study, and how they feel about the treatment.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

Start

01 Feb 2026

Estimated completion

01 Feb 2028

Crohn Disease (CD)Ulcerative Colitis (UC)Fatigue

What is this study about?

Many people living with inflammatory bowel disease (IBD), like Crohn's disease and ulcerative colitis, often feel very tired, even when their gut health is managed. This tiredness isn't just about feeling sleepy; it can also affect your thinking, making it hard to concentrate (sometimes called 'brain fog'). Currently, there aren't many good treatments specifically for this kind of fatigue in IBD.

This study is looking into whether a medication called modafinil could help. Modafinil has been used for many years to help people with conditions like narcolepsy, where people have trouble staying awake during the day. It's known to help people feel more awake and can improve mental alertness quickly. The main purpose of this study is not to find a cure, but to see if it's practical and safe to run a larger, more detailed study on modafinil for IBD-related fatigue in the future. This is called a 'feasibility study'.

To do this, the study will compare modafinil with a 'placebo', which is a dummy tablet that looks exactly like the real drug but contains no active ingredient. This comparison helps researchers understand if any improvements are genuinely due to the modafinil or just because people expect to feel better. Half of the participants will receive modafinil, and the other half will receive the placebo. You won't know which one you're taking, and neither will the study team, until the study is over.

Key takeaways

This study investigates modafinil for fatigue in Crohn's disease and ulcerative colitis.
It's a small 'feasibility' study to check if a larger trial is possible.
Participants will receive either modafinil or a dummy pill (placebo) for 12 weeks.
You'll complete questionnaires about your fatigue and general well-being.
Appointments can be in person or sometimes online.
The findings will help decide if a bigger study should be done.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have a confirmed diagnosis of Crohn's disease or ulcerative colitis. You should also have been experiencing significant tiredness for at least six months that affects your daily life. Your IBD should be stable, meaning your gut inflammation levels (checked by a stool test) and red blood cell count (hemoglobin) should be within certain limits, and your thyroid and vitamin B12 levels should be normal. If you are a woman of childbearing age, you'll need to use effective contraception during the study and have a negative pregnancy test before starting.

There are also some reasons why you might not be able to join. For example, if you have certain mental health conditions like psychosis, bipolar disorder, or a history of drug or alcohol dependence, or if you're currently taking certain stimulant medications or specific other drugs, you wouldn't be eligible. The study also needs to make sure there are no reasons why modafinil wouldn't be suitable for you, based on current medical guidelines.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Crohn's disease or ulcerative colitis?
Have you had significant fatigue for 6 months or more?
Are your IBD, thyroid, and vitamin B12 levels generally stable?
Are you able to provide written consent to take part?
Are you currently not taking certain other stimulant or psychiatric medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like flipping a coin) to receive either modafinil or a dummy pill for 12 weeks. You'll start by taking one tablet, and if needed, you might gradually increase to two or three tablets. During the study, you'll have appointments after 6 and 12 weeks. These appointments can be in person at one of the hospitals in London, or sometimes online if that's easier for you.

Throughout the study, you'll complete various questionnaires. These will ask about your fatigue, your mental wellbeing, and your gut health. These questionnaires help the researchers understand how you're feeling and how the treatment might be affecting you. The total duration of your active involvement with the study medication and main follow-up will be 12 weeks, with additional checks as needed.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a medication that could help lessen your fatigue, or at least contributing to medical research that could help future patients with IBD-related fatigue. It's important to remember that because you might receive a dummy pill, there's no guarantee the treatment will help you personally. As with any medication, modafinil can have side effects, and some people might not respond well to it. The research team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom
St Mark's Hospital
Verified postcode
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom
King's College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is IBD fatigue?

IBD fatigue is a common and often severe tiredness that people with Crohn's disease or ulcerative colitis experience, even when their gut condition is well managed. It can affect physical energy and mental clarity.

What is modafinil and what does it do?

Modafinil is a medication that helps people feel more awake and can improve concentration. It's been used for a long time to treat conditions where people have excessive daytime sleepiness.

What does 'feasibility study' mean?

A feasibility study is a smaller trial designed to test if a larger study is possible to conduct. It looks at things like how many people are willing to join, finish the study, and how they feel about the treatment, rather than purely focusing on how effective the treatment is.

Will I know if I'm getting modafinil or the dummy pill?

No, neither you nor the study team will know whether you are receiving modafinil or the dummy pill until after the study is completed. This is called 'blinding' and helps keep the study fair.

Where will I have my appointments?

Your appointments can take place at specific hospitals in London or, if it's more convenient for you, some assessments can be done online.

How to find out more

Calum Moulton, MA MRCP MRCPsych PhD

calum.moulton@nhs.net +44 07384 799297 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.