Glucocorticoid enhancement of food exposure therapy in Binge Eating Disorder
This research study is investigating a new way to help people with Binge Eating Disorder. The main goal is to see if a drug called hydrocortisone, which is similar to a natural body hormone, can reduce intense cravings for food. Researchers will check if participants experience fewer cravings when they are around real food, typically 3 to 7 days after receiving the treatment. The study will also look at how this treatment affects feelings of losing control over eating, stress, and general food cravings, both shortly after treatment and up to one month later. It's a Phase II study, meaning it's an early-stage trial trying to find out if the treatment works and what dose might be best.
At a glance
What is this study about?
This research study is exploring a new approach for people who experience Binge Eating Disorder. This condition involves eating a large amount of food quickly, often feeling a loss of control, and afterwards experiencing feelings like guilt or shame. The study is investigating a medication called hydrocortisone, which is similar to a hormone your body naturally produces called cortisol. Cortisol plays a role in how your body handles stress and also affects appetite.
The main idea behind this study is to see if giving hydrocortisone can help reduce the strong urges and cravings people with Binge Eating Disorder often feel when they are around food. Specifically, the researchers want to find out if participants experience less intense food cravings when presented with real food in the days following the treatment. This is considered an early-stage study (Phase II), which means it's one of the first steps in testing a new treatment. These types of studies help us understand if a treatment is effective and safe before it moves on to larger trials.
Beyond just cravings, the study will also look at other important aspects. For example, it will check if the treatment helps reduce feelings of fear about losing control over eating, how much stress or upset people feel around food, and if it affects how much food people actually eat. They will also track if binge eating episodes and overeating become less frequent after the treatment. This comprehensive look helps researchers understand the full picture of how the treatment might help.
Key takeaways
- The study uses hydrocortisone to try and reduce food cravings in Binge Eating Disorder.
- It's an early-stage (Phase II) trial to see if the treatment works.
- Researchers will check for reduced cravings and feelings of losing control around food.
- Participants will receive either hydrocortisone or a dummy pill (placebo).
- It aims to see effects within days and again after one month.
- Age 18 and over, open to all genders.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
More detailed specific requirements will be discussed with you by the research team. Things like your current health, any other medications you’re taking, and whether you have certain other conditions will be carefully considered to make sure the study is a good fit for you and that it's safe for you to take part.
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 Binge Eating Disorder?
- Are you able to attend clinic visits as required?
- Are you willing to potentially receive either the study drug or a placebo?
- Are you comfortable with the study tracking your food cravings and eating habits?
What does participation involve?
If you decide to take part, you would receive either the study medication (hydrocortisone) or a placebo. A placebo is a dummy pill that looks just like the study medication but contains no active drug. This helps researchers understand if any changes are due to the medication itself or other factors. You would take these capsules as directed by the study team.
Over the course of the study, you would have several visits to the clinic. These visits would involve assessments to measure your food cravings, feelings about eating, and possibly your actual food intake. This would happen both a few days after you start treatment and again about one month later. The study team would also track how often you experience binge eating or overeating episodes. The exact number of visits, tests, and the total length of your participation would be explained in detail before you agree to join.
Potential risks and benefits
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Common questions
What is Binge Eating Disorder?
It's a condition where a person regularly eats a lot of food in a short time, often feeling a loss of control, and feels upset or guilty afterwards.
What is hydrocortisone?
It's a medication that acts like a natural hormone in your body called cortisol, which is involved in stress and appetite.
What is a 'placebo'?
A placebo is a 'dummy pill' that looks real but contains no active medicine. It helps researchers see if the real drug is making a difference.
Will I know if I'm getting the real medicine or the placebo?
No, often in these studies, neither you nor the study team will know who is getting which. This helps keep the results fair and unbiased.
How long will I be in the study?
The study looks at effects a few days after treatment and then again after one month. The full duration of your involvement, including all visits, will be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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