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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

Cortisol – Cortisol is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in enhancing food exposure therapy for Binge Eating Disorder. The main therapeutic indication being explored is the reduction of food cravings in individuals with this disorder. At the molecular level, cortisol works by influencing the body's stress response, potentially altering the way the brain processes cravings and stress-related eating behaviors. It is classified as a glucocorticoid, a type of steroid hormone that affects various bodily functions, including metabolism and immune response.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515475-35-00Protocol code2020-01131Estimated enrolment50 patientsSponsorUniversitaetsmedizin Goettingen

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).