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

Summary

Behavioural addictions (BAs) \[gambling disorder (GD), food addiction (FA), sexual addiction (SA)\] may lead to disastrous consequences. They are often associated with other addictive or psychiatric disorders, and high rates of suicide attempts. Epidemiological studies report prevalence reaching 2.7% for GD, 5% for SA, and up to 7.9% for FA.

Many similarities have been highlighted between BAs, as well as with substance use disorders. One core clinical similarity between those disorders is craving (uncontrollable urge to engage in rewarding behaviours), which has been consistently associated with diminished control over the behaviour and relapse.

At present, no pharmacological treatment has been approved for BAs, but several medications have been tested. Among them, two opioid receptor antagonists - naltrexone and nalmefene - appear the most promising. By decreasing dopamine neurotransmission in the reward circuitry, they reduce both excitement for rewarding behaviours and craving.

Compared to naltrexone, nalmefene seems to have a better safety. To date, no study investigated the efficacy of nalmefene as a pan-addiction treatment for BAs. Two clinical trials have demonstrated its efficacy for the treatment of GD, but no clinical trial was conducted for FA and SA.

The investigators hypothesise that nalmefene (36 mg/d), compared to a placebo, can have a therapeutic effect as an add-on to usual treatment for decreasing craving in several BAs.

Conditions

• Behavioural Addiction

Interventions

DRUG

Nalmefene

Week 1: 18 mg/d Week 2: 1. In the absence of ARs or in the presence of grade 1 or 2 ARs, 36 mg/d 2. In the presence of grade 3 ARs, 18 mg/d 3. In the presence of grade 4 ARs, treatment will be stopped immediately. Week 3 to week 5: 1. In case of acceptable safety profile at the 18mg/d dosage during week 2, the treatment will be maintained at the same dosage 2. In the presence of sustained grade 3 ARs at the 18mg/d dosage during week 2, the treatment will be stopped. 3. In case of acceptable safety profile at the 36mg/d dosage during week 2, the treatment will be maintained at the same dosage 4. In the presence of grade 3 ARs at the 36mg/d dosage during week 2, the treatment dosage will be decreased at 18mg/d 5. Whatever the dosage during week 2, in the presence of grade 4 ARs, the treatment will be stopped immediately.

DRUG

Placebo

Week 1: 1 tablet/d Week 2: 1. In the absence of ARs or in the presence of grade 1 or 2 ARs, 2 tablets/d 2. In the presence of grade 3 ARs, 1 tablet/d 3. In the presence of grade 4 ARs, the treatment will be stopped immediately. Week 3 to week 5: 1. In case of acceptable safety profile at the dosage of 1 tablet/d during week 2, the treatment will be maintained at the same dosage 2. In the presence of sustained grade 3 ARs at the dosage of 1 tablet/d during week 2, the treatment will be stopped. 3. In case of acceptable safety profile at the dosage of 2 tablets/d during week 2, the treatment will be maintained at the same dosage 4. In the presence of grade 3 ARs at the dosage of 2 tablets/d during week 2, the treatment dosage will be decreased at 1 tablet/d 5. Whatever the dosage during week 2, in the presence of grade 4 ARs, the treatment will be stopped immediately.

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Marie GRALL-BRONNEC · Nantes University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-31

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• France

Study Locations