Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects

Double-blind, Randomised, Parallel-group, Three-arm, Dose Range, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy, Tolerability and Safety of a Combination of Cypropheptadine and Prazosin on Alcohol Consumption in Patients With Severe Alcohol Use Disorder

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).

Inclusion Criteria:

• Severe alcohol use disorder
• High-risk alcohol consumption

Exclusion Criteria:

• Patient with orthostatic hypotension
• Patient with hypotension
• History of uncontrolled hypertension
• Patient at risk for urinary retention associated with urethroprostatic disorders
• Patient with a clinically-active malignancy
• Patient with a confirmed cirrhosis
• History of bronchial asthma
• History of uncontrolled hyperthyroidism
• History of cardiovascular disease not under control
• Severe psychiatric disorder
• History of alcohol withdrawal syndrome