Alcohol Use Disorder
Conditions
Brief summary
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).
Interventions
DRUGCyproheptadine
3-month treatment
DRUGAlpress LP
3-month treatment
Sponsors
ECSOR
Kinnov Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean quantity of alcohol consumed per day in the three groups | weeks 9 to 12 |
Countries
France
Outcome results
None listed