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Study on Nalmefene and Placebo for Reducing Cravings in Patients with Gambling Disorder, Sexual Addiction, or Food Addiction

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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 the effects of a medication called nalmefene on individuals with certain types of behavioral addictions. These addictions include gambling disorder, sexual addiction, and food addiction. The study aims to see if nalmefene can help reduce the intensity of cravings that people with these addictions experience. Participants in the study will receive either nalmefene or a placebo, which is a substance that looks like the medication but does not have any active ingredients.

The purpose of the study is to assess how effective nalmefene is when used alongside the usual treatment for these addictions. Participants will be asked to regularly report their craving episodes over the course of the study. The study will track changes in the intensity, frequency, and duration of these cravings from the start to the end of the treatment period. Additionally, the study will look at overall clinical improvement and any side effects experienced by participants.

The study will last for a period of time, during which participants will take the medication or placebo and report their experiences. The goal is to gather information on how nalmefene affects cravings and whether it can be a helpful addition to existing treatments for behavioral addictions. This information will help researchers understand the potential benefits and any risks associated with using nalmefene for these conditions.

The research process

The trial runs in 6 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, you will be required to provide your written informed consent. This confirms your understanding and agreement to participate in the clinical trial.

    You must be at least 18 years old and have been diagnosed with a behavioral addiction such as gambling disorder, sexual addiction, or food addiction.

    You will need to be affiliated with the French social security system or be a beneficiary of it.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current condition. This includes reporting any craving episodes you have experienced, with an intensity of at least 4 out of 10 on a scale called the Numerical Rating Scale (NRS).

    Women participating in the study must meet specific criteria regarding pregnancy prevention or post-menopausal status.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive either nalmefene or a placebo. Nalmefene is provided in 18 mg film-coated tablets.

    The dosage may be adjusted to a maximum of 36 mg per day, depending on your tolerance.

    You will continue your usual treatment for behavioral addiction alongside the study medication.

  4. Step 4

    Weekly diary

    You will be required to maintain a weekly diary to record the intensity, frequency, and duration of your craving episodes.

    This diary will help assess the variation in your craving episodes from the start to the end of the treatment.

  5. Step 5

    End of treatment assessment

    At the end of the treatment, an assessment will be conducted to evaluate the changes in your craving episodes.

    The primary focus will be on the variation in the intensity of your cravings, as recorded in your weekly diary.

  6. Step 6

    Follow-up

    A follow-up assessment will occur four weeks after the end of the treatment to evaluate any lasting effects.

    This will include a review of your craving episodes and any changes in your daily life behaviors related to gambling, sex, or food.

Who can join the trial?

12 criteria

  • Must be a male or female who is 18 years or older.
  • Must be a patient who is already receiving care or starting care in departments that treat addictions for a behavioral addiction, which includes:
    • Gambling disorder
    • Food addiction
    • Sexual addiction
    • Must be able to regularly assess and report their craving episodes (strong desires to engage in addictive behavior) on a weekly diary.
    • Must provide their written informed consent (agreement to participate after understanding the study).
    • Must be affiliated with the French social security system or be a beneficiary of such a system.
    • Must have experienced at least one episode of craving with an intensity of 4 out of 10 or higher on the NRS (Numeric Rating Scale) during the week before joining the study.
    • Women must meet one of the following criteria at the time of joining:
      • Use adequate contraceptive measures as recommended and have a negative pregnancy test before receiving the first dose of the study drug.
      • Be post-menopausal (over 50 years of age with no menstrual periods for at least 12 months after stopping all external hormone treatments).
      • If under 50 years of age, have been without menstrual periods for at least 12 months after stopping external hormone treatments and have hormone levels that match post-menopausal levels.
      • Have undergone irreversible surgical sterilization (such as removal of the uterus, both ovaries, or both fallopian tubes).

Who cannot join the trial?

3 criteria

  • Patients with **gambling disorder** cannot participate. This means if you have a strong urge to gamble that affects your life, you are not eligible.
  • Patients with **sexual addiction** cannot participate. This refers to having an uncontrollable urge to engage in sexual activities.
  • Patients with **food addiction** cannot participate. This means if you have an overwhelming desire to eat that affects your life, you are not eligible.
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Investigated drugs

Nalmefene is a medication used in this clinical trial to help reduce cravings in people with certain behavioral addictions, such as gambling disorder, sexual addiction, and food addiction. It works by affecting the brain's reward system, which can help decrease the urge to engage in addictive behaviors. In this study, nalmefene is being tested to see how well it can reduce the intensity of craving episodes when added to the usual treatment that patients are already receiving.

What is already known about the treatment

Nalmefene – Nalmefene is administered orally in tablet form and is currently being studied for its effectiveness in treating behavioral addictions such as gambling disorder, sexual addiction, and food addiction. It is not yet widely established in medical practice for these conditions, but it is being evaluated in clinical trials. The main therapeutic indication is to reduce the intensity of craving episodes in patients with these behavioral addictions. At the molecular level, nalmefene works by blocking certain receptors in the brain that are involved in the reward system, which helps to decrease the urge to engage in addictive behaviors. It is classified as an opioid receptor modulator.

Investigated diseases

  • Gambling Disorder

    Gambling Disorder is characterized by a persistent and recurrent problematic gambling behavior that leads to significant impairment or distress. Individuals with this disorder often experience an increasing need to gamble with more money to achieve the desired excitement. They may become restless or irritable when attempting to cut down or stop gambling. The disorder progresses as individuals continue to gamble despite negative consequences, such as financial loss or damaged relationships. Over time, they may resort to lying or illegal acts to finance their gambling. The behavior becomes more compulsive, and the individual may lose control over their gambling activities.

  • Sexual Addiction

    Sexual Addiction, also known as hypersexual disorder, involves an excessive preoccupation with sexual fantasies, urges, or behaviors that are difficult to control. Individuals with this condition may spend a significant amount of time engaging in sexual activities, often at the expense of other important life areas. The disorder progresses as the individual continues to engage in these behaviors despite negative consequences, such as relationship issues or legal problems. Over time, the compulsive nature of the behavior can lead to a loss of control and an inability to resist the urge to engage in sexual activities. The individual may experience distress or impairment in social, occupational, or other important areas of functioning. The behavior often becomes more frequent and intense, leading to further negative impacts on the individual's life.

  • Food Addiction

    Food Addiction is characterized by an uncontrollable urge to consume certain foods, often high in sugar, fat, or salt, despite negative consequences. Individuals with this condition may experience cravings and a loss of control over their eating habits. The disorder progresses as the individual continues to consume these foods in large quantities, leading to physical and emotional distress. Over time, the compulsive eating behavior can result in weight gain, health problems, and difficulties in daily functioning. The individual may experience feelings of guilt or shame about their eating habits but find it challenging to stop. The behavior often becomes more frequent and intense, further impacting the individual's health and well-being.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500085-96-00Protocol codeRC21_0336Estimated enrolment266 patientsSponsorCentre Hospitalier Universitaire De Nantes

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