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

What this Trial Is About

Researchers are studying behavioural addictions including gambling disorder, food addiction, and sexual addiction, which can have serious consequences and are often linked with other psychiatric or addictive disorders and high suicide attempt rates. This trial evaluates whether nalmefene, an opioid receptor antagonist, can reduce craving, a key symptom shared by these addictions, when added to usual treatment. Nalmefene may have a better safety profile than a similar drug, naltrexone, and this study is the first to assess its effect across multiple behavioural addictions. Participants will receive either nalmefene or a placebo alongside their usual care. Nalmefene dosing starts at 18 mg daily in the first week and may increase to 36 mg daily in the second week if side effects are mild. Depending on safety and side effects, the dose is maintained or adjusted during weeks 3 to 5, with treatment stopped if severe reactions occur. The placebo group follows a similar dosing schedule with tablets instead of nalmefene. Treatment lasts 5 weeks, followed by 4 weeks of monitoring without treatment. During the trial, participants will regularly record their craving episodes in weekly diaries. Researchers will assess changes in the intensity, frequency, and duration of cravings and addictive behaviours from the start of treatment through 4 weeks after treatment ends. Clinical improvement will be measured using standard scales, and safety will be monitored by tracking side effects. Additional data on psychiatric and addictive history will be collected at the start. Participation may last up to 9 weeks including follow-up.

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