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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
266
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.
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.
CHU de Besançon
Besançon, France
NOT_YET_RECRUITINGCHU de Bordeaux
Bordeaux, France
RECRUITINGCHRU de Brest
Brest, France
RECRUITINGCHU de Clermont Ferrand
Clermont-Ferrand, France
RECRUITINGCHU de Dijon
Dijon, France
NOT_YET_RECRUITINGCH de La Rochelle
La Rochelle, France
RECRUITINGHospices Civils de Lyon
Lyon, France
RECRUITINGCHU de Montpellier
Montpellier, France
NOT_YET_RECRUITINGCHU de Nantes
Nantes, France
RECRUITINGCHU de Nîmes
Nîmes, France
RECRUITING...and 3 more locations
Variation of averaged intensity of craving episodes between start and end of treatment.
Variation of averaged intensity of craving episodes between start (during the week preceding initiation of treatment) and end (during the week preceding end of treatment) of treatment. Each craving episode will be reported by the patient on a weekly diary, with intensity assessed through a Numerical Rating Scale (NRS) form 0 to 10 (0=lowest intensity and 10= highest intensity).
Time frame: 5 weeks
Variation of averaged weekly frequency (number of episodes) of craving episodes between start and end of treatment.
Time frame: 5 weeks
Variation of averaged weekly duration (cumulative duration of all episodes) of craving episodes between start and end of treatment.
Time frame: 5 weeks
Variation of averaged weekly intensity, frequency and duration of craving episodes between start of treatment and 4 weeks after the end of treatment.
Time frame: 9 weeks (5 weeks of treatment +4 weeks of follow up after treatment)
Variation of averaged weekly frequency of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Time frame: 9 weeks
Variation of averaged weekly duration of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Time frame: 9 weeks
Variation of averaged weekly intensity of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Assessed through a Numerical Rating Scale (NRS) form 0 (lowest intensity) to 10 (highest intensity)
Time frame: 9 weeks
Overall clinical improvement, assessed though the Clinical Global Impression - Improvement (CGI-I) scale.
Time frame: 9 weeks
Overall clinical improvement, assessed though the GGI - Efficacy Index (CGI-EI).
Time frame: 9 weeks
Variation of averaged weekly use of psychoactive substances (including nicotine) and daily life behaviors of interest (gambling, sex, food) between start of treatment and 4 weeks after the end of treatment
Time frame: 9 weeks
Number, type and severity of self-reported adverse side effects, during either weeks of treatment at a dosage of 18 mg/d or 36 mg/d.
Time frame: 9 weeks
Mutation(s) associated with non-response to nalmefene treatment
Time frame: 9 weeks
Sociodemographic, medical and clinical data, especially psychiatric and addictive co-morbidities assessed with the Mini International Neuropsychiatric Interview - Simplified (MINI-S) and the age of the BA
Time frame: 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.