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

PHASE3RecruitingINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2027

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."

Trial Locations (13)

17000

RECRUITING

CH de La Rochelle, La Rochelle

21000

NOT_YET_RECRUITING

CHU de Dijon, Dijon

29200

RECRUITING

CHRU de Brest, Brest

30000

RECRUITING

CHU de Nîmes, Nîmes

33000

RECRUITING

CHU de Bordeaux, Bordeaux

34295

NOT_YET_RECRUITING

CHU de Montpellier, Montpellier

37000

RECRUITING

CHRU de Tours, Tours

63000

RECRUITING

CHU de Clermont Ferrand, Clermont-Ferrand

67000

RECRUITING

Hôpitaux Universitaires de Strasbourg, Strasbourg

69000

RECRUITING

Hospices Civils de Lyon, Lyon

94800

RECRUITING

Hôpital Paul Brousse, Villejuif

Unknown

NOT_YET_RECRUITING

CHU de Besançon, Besançon

RECRUITING

CHU de Nantes, Nantes

All Listed Sponsors
lead

Nantes University Hospital

OTHER