Study on Hydrocortisone and Food Exposure Therapy for Patients with Binge Eating Disorder

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What is this study about?

This clinical trial is focused on studying Binge Eating Disorder, a condition where individuals frequently consume large amounts of food and feel a lack of control over their eating habits. The study will explore the effectiveness of a treatment that combines food exposure therapy with a medication called Hydrocortisone. Hydrocortisone is a type of glucocorticoid, which is a hormone that can influence stress responses in the body. The trial will compare the effects of this combination treatment to a placebo, which is a substance with no active medication, to see if it helps reduce cravings for food in people with Binge Eating Disorder.

The purpose of the study is to determine if the combination of food exposure therapy and hydrocortisone is more effective than food exposure therapy alone in reducing food cravings. Participants will undergo sessions where they are exposed to real food while taking either hydrocortisone or a placebo. The study will monitor changes in food cravings, feelings of losing control over eating, and emotional responses to food over a period of time. The goal is to see if the treatment can help decrease the desire to binge eat and improve control over eating habits.

Participants will be involved in the study for a period that includes treatment sessions and follow-up assessments. The study will track the decrease in food cravings and other related behaviors both shortly after treatment and up to one month later. This research aims to provide insights into new ways to help individuals manage Binge Eating Disorder more effectively.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of Binge Eating Disorder (BED), and ability to understand and comply with trial procedures.

2 initial assessment

An initial assessment is conducted to evaluate baseline levels of food craving, fear of loss of control over eating, and other related factors.

3 treatment phase

Participants receive either a placebo or hydrocortisone tablets. Hydrocortisone is administered orally at a dosage of 10 mg.

The treatment involves exposure to real food with response prevention (ERP) to assess its impact on food craving and related behaviors.

4 follow-up assessment

A follow-up assessment is conducted 3-7 days after treatment to measure changes in food craving and other primary endpoints.

Secondary endpoints such as fear of loss of control over eating, arousal/distress, and food intake are also evaluated.

5 long-term follow-up

Participants are monitored for a month after treatment to assess long-term effects on food craving, binge eating episodes, and other related behaviors.

Who Can Join the Study?

  • Patients must have Binge Eating Disorder (BED), which is a condition where a person frequently eats large amounts of food and feels unable to stop.
  • Participants can be either male or female and must be between the ages of 18 and 40. The upper age limit is set to avoid any effects from hormonal changes related to menopause.
  • Participants must provide written informed consent, which means they agree to take part in the study after being fully informed about it, following international guidelines and local laws.
  • Participants must be able to understand what the trial is about and what procedures it involves, and they must be able to follow these procedures.

Who Cannot Join the Study?

  • Individuals who are not diagnosed with Binge Eating Disorder cannot participate. Binge Eating Disorder is a condition where a person frequently eats large amounts of food and feels unable to stop.
  • Participants must be within a specific age range, typically adults, to be eligible.
  • Both males and females can participate, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
03.01.2024

Trial locations

Investigated drugs:

Cortisol is a hormone that is naturally produced by the adrenal glands. In this clinical trial, it is used to enhance the effects of food exposure therapy. The goal is to see if combining cortisol with therapy can better reduce cravings for food in individuals with Binge Eating Disorder.

Food Exposure Therapy with Response Prevention (ERP) is a type of behavioral therapy used in this trial. It involves exposing individuals to food in a controlled setting while preventing their usual response, such as binge eating. The aim is to help reduce cravings and change eating behaviors in people with Binge Eating Disorder.

Investigated diseases:

Binge Eating Disorder – Binge Eating Disorder is characterized by recurrent episodes of eating large quantities of food, often quickly and to the point of discomfort. Individuals with this disorder may feel a lack of control during these episodes and experience feelings of shame or guilt afterward. Unlike other eating disorders, binge eating is not followed by purging behaviors such as vomiting or excessive exercise. The disorder can lead to weight gain and associated health issues over time. It often involves emotional distress and can be triggered by stress, negative emotions, or boredom. The frequency and severity of binge eating episodes can vary among individuals.

Trial ID:
2024-515475-35-00
Protocol code:
2020-01131
Trial Phase:
Therapeutic exploratory (Phase II)

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