Double-blind randomised, parallel-group, three-arm, multicentre, placebo-controlled study The primary objective is to demonstrate the superiority of the combination of Periactine® (cyproheptadine 8 mg/day or 12 mg/day) and Alpress® (prazosin 5 mg/day or 10 mg/day) over placebo on the reduction of the total alcohol consumption (TAC), in alcohol-dependent patients. 180 patients will be randomised into the two treatment groups (N=60 in the low-dose group and N=60 in the high-dose group) and the placebo group (N=60).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
3-month treatment
3-month treatment
Centre Hospitalier d'Abbeville
Abbeville, France
Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie
Agen, France
clinique de la Bréhonnière
Astillé, France
Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia
Bayonne, France
Centre Hospitalier de la Côte Basque - Service d'addictologie
Bayonne, France
Change in the mean quantity of alcohol consumed per day in the three groups
Time frame: weeks 9 to 12
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Cabinet Médical
Bersée, France
CHRU Brest - Hôpital Cavale Blanche
Brest, France
HIA Clermont Tonnerre
Brest, France
Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier
Bron, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
...and 25 more locations