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RecruitingPHASE3INTERVENTIONAL

NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions

This clinical trial is investigating a medication called Nalmefene to see if it helps people manage strong urges, or 'craving', associated with behavioural addictions like gambling, food, or sexual addiction. Many people experience these addictions, which can have serious effects on their lives. Currently, there isn't an approved medication specifically for these conditions. Researchers believe Nalmefene, which has shown promise in reducing cravings in similar conditions, could offer a new way to help. Participants will receive either Nalmefene or a dummy pill (placebo) alongside their regular treatment, and researchers will compare how well each group manages their cravings. This is a Phase 3 study, which means it's a key step in understanding if Nalmefene could be a future treatment option.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Nantes University Hospital
Enrolment target
266
Start
31 Mar 2023
Estimated completion
01 Jul 2027

What is this study about?

This study is about understanding how to better help people who experience behavioural addictions such as problem gambling, difficulties with food (sometimes called food addiction), or obsessive sexual behaviours. These conditions can be very challenging and impact many aspects of a person's life, sometimes leading to other health issues or mental health struggles.

A common thread across these behavioural addictions, and even with drug and alcohol problems, is something called 'craving'. This isn't just a mild desire; it's a very strong, uncontrollable urge to engage in a particular behaviour. This craving often makes it harder for people to stop or cut down, leading to a cycle that can be tough to break. Currently, there aren't any specific medications approved to treat these types of cravings.

However, there's a particular type of medication, called opioid receptor antagonists, that has shown potential. These medications work by affecting certain brain chemicals, which can reduce the feelings of excitement associated with these behaviours and, importantly, lessen the cravings. This study is focusing on one such medication, Nalmefene, which previous research suggests might be safer and effective. Researchers want to see if Nalmefene, when taken along with a person's usual care, can help reduce craving across different behavioural addictions.

Key takeaways

  • This study explores a new medication, Nalmefene, for behavioural addictions.
  • It focuses on reducing 'craving' for gambling, food, or sex.
  • Participants will receive either Nalmefene or a placebo, alongside their usual treatment.
  • The study aims to find an effective medication where currently none exist.
  • All participants are given existing care; the study medicine is an additional treatment.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You must have been diagnosed with either a gambling disorder, food addiction, or sexual addiction, and be receiving or starting care for this condition in an addiction treatment centre. You’ll also need to be able to keep a weekly record of your cravings.

There are also some requirements for women who could become pregnant. They would need to be using reliable birth control, or have gone through menopause, or have had certain surgical procedures. All participants must provide written permission to take part, and be part of the French social security system.

However, you can't join if you’re already taking other medications specifically aimed at reducing cravings for behavioural addictions (like naltrexone or bupropion, among others). Also, if you have any health condition that would make it unsafe for you to take Nalmefene, you would not be able to participate.

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.

  1. Are you 18 years or older?
  2. Do you have a diagnosed gambling disorder, food addiction, or sexual addiction?
  3. Are you receiving or starting addiction care?
  4. Can you regularly track and report your cravings?
  5. Are you NOT currently taking other specific anti-craving medications for addiction?
Answer every question to see your result.

What does participation involve?

The detailed information on participation, including the number of visits, assessments, medication schedule, follow-up, and total duration, is not provided in the brief or detailed description. Generally, in a Phase 3 trial like this, you would likely have regular clinic visits, receive either the study drug (Nalmefene) or a placebo (a dummy pill), and be asked to keep a diary of your cravings. You might also have blood tests and other health checks. The study would likely last several weeks or months. Full details would be explained by the study team.

Potential risks and benefits

Taking part in this study could offer the potential benefit of helping to reduce your cravings and improve your ability to manage your addiction. The medication being tested, Nalmefene, has been studied before and is believed to have a good safety profile, but like all medications, it could have side effects. You will be closely monitored for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

  • CHU de Besançon
    Verified postcode
    Besançon, France· Not yet recruiting
  • CHU de Bordeaux
    Verified postcode
    Bordeaux, France· Recruiting
  • CHRU de Brest
    Verified postcode
    Brest, France· Recruiting
  • CHU de Clermont Ferrand
    Verified postcode
    Clermont-Ferrand, France· Recruiting
  • CHU de Dijon
    Verified postcode
    Dijon, France· Not yet recruiting
  • CH de La Rochelle
    Verified postcode
    La Rochelle, France· Recruiting
  • Hospices Civils de Lyon
    Verified postcode
    Lyon, France· Recruiting
  • CHU de Montpellier
    Verified postcode
    Montpellier, France· Not yet recruiting
  • CHU de Nantes
    Verified postcode
    Nantes, France· Recruiting
  • CHU de Nîmes
    Verified postcode
    Nîmes, France· Recruiting
  • Hôpitaux Universitaires de Strasbourg
    Verified postcode
    Strasbourg, France· Recruiting
  • CHRU de Tours
    Verified postcode
    Tours, France· Recruiting

Common questions

What is 'craving' in this study?

In this study, 'craving' means a very strong, uncontrollable urge or desire to engage in behaviours related to your addiction. It's more than just wanting something; it's a powerful impulse.

What is Nalmefene?

Nalmefene is a medication that works by affecting certain chemicals in your brain. It's thought to help reduce the 'reward' feeling from addictive behaviours and lessen cravings.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medication but does not contain any active drug. In this study, some people will get Nalmefene and some will get the placebo to see if the medication has a real effect.

Will I still receive my usual treatment during the study?

Yes, this study tests Nalmefene "in addition to treatment as usual." This means you will continue to receive your regular care and support for your addiction alongside either Nalmefene or the placebo.

Why is this study important?

This study is important because currently there are no approved medications specifically for behavioural addictions. If Nalmefene proves effective, it could offer a new and much-needed treatment option for people struggling with these conditions.

How to find out more

Marie GRALL-BRONNEC

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

Interested in taking part?

Register your interest

Share your details and the research team for "NAlmefene Versus Placebo in Addition to Treatment as Usual o…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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