Clinical Trials for Behavioural Addiction
Currently, there is one ongoing clinical trial investigating new treatment approaches for behavioural addiction. This trial is exploring how nalmefene, a medication that affects the brain’s reward system, may help reduce cravings in people experiencing gambling disorder, sexual addiction, or food addiction. The study is being conducted in France and aims to evaluate whether this medication can provide additional benefit when used alongside standard treatments.
Clinical trial locations
Study on Nalmefene and Placebo for Reducing Cravings in Patients with Gambling Disorder, Sexual Addiction, or Food Addiction
This clinical trial is investigating whether nalmefene can help reduce the intensity of cravings in people living with behavioural addictions. The study focuses specifically on three types of behavioural addiction: gambling disorder, sexual addiction, and food addiction.
Who can participate?
To be eligible for this study, participants must meet several criteria:
- Be at least 18 years old
- Currently be receiving care, or starting care, in addiction treatment departments for gambling disorder, food addiction, or sexual addiction
- Be able to regularly track and report episodes of strong cravings on a weekly basis
- Be affiliated with or a beneficiary of the French social security system
- Have experienced at least one craving episode with an intensity of 4 out of 10 or higher in the week before joining the study
For women participating in the study, additional requirements apply regarding pregnancy prevention measures or confirmation of post-menopausal status. This includes using adequate contraception with a negative pregnancy test, being post-menopausal, or having undergone surgical sterilization.
Who cannot participate?
The exclusion criteria for this trial may seem contradictory at first glance, as they list the same conditions that the study is designed to treat. This likely reflects specific subtypes or severity levels that are not suitable for the study protocol. Participants should discuss their individual circumstances with the research team to determine eligibility.
What is the goal of the trial?
The main purpose of this research is to assess how effective nalmefene is at reducing the intensity, frequency, and duration of craving episodes when used alongside usual treatment for behavioural addictions. Participants will keep a weekly diary to track their cravings throughout the study period. Researchers will compare the changes in craving intensity from the beginning to the end of treatment, and they will also evaluate overall clinical improvement and any side effects that participants experience.
How does the study work?
Participants will be randomly assigned to receive either nalmefene or a placebo (an inactive substance that looks like the medication). The nalmefene is provided as 18 mg tablets, and the dosage may be adjusted up to a maximum of 36 mg per day depending on how well each person tolerates it. Importantly, participants will continue their usual treatment for their behavioural addiction throughout the study.
During the treatment phase, participants will maintain a weekly diary recording the intensity, frequency, and duration of their craving episodes. At the end of the treatment period, researchers will assess changes in these craving patterns. A follow-up assessment will take place four weeks after treatment ends to evaluate any lasting effects and review any changes in daily behaviours related to gambling, sex, or food.
About the investigational drug
Nalmefene is a medication that works by affecting the brain’s reward system. Specifically, it blocks certain receptors in the brain that are involved in reinforcing addictive behaviours, which can help decrease the urge to engage in these activities. While nalmefene is being studied for behavioural addictions in this trial, it is not yet widely established in medical practice for these specific conditions. The medication is classified as an opioid receptor modulator and is taken orally in tablet form.
Summary
Currently, research into treatments for behavioural addiction is limited, with only one active clinical trial identified. This trial is taking place exclusively in France and represents an important step in exploring pharmacological approaches to managing behavioural addictions. The focus on nalmefene is particularly noteworthy, as this medication targets the brain’s reward pathways, which are central to addictive behaviours.
The study’s approach of adding nalmefene to existing treatments, rather than replacing them, reflects a practical understanding that behavioural addictions often require comprehensive care. By tracking craving intensity through patient diaries, researchers are taking a patient-centred approach to measuring treatment effectiveness. The inclusion of a follow-up period after treatment ends will provide valuable information about whether any benefits persist over time.
For individuals living with gambling disorder, sexual addiction, or food addiction in France, this trial may offer an opportunity to access a potential new treatment option while contributing to scientific understanding of these challenging conditions.
