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

Study Overview
=================
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).

Official Title
-----------------
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

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Drug: Cyproheptadine
* Drug: Alpress LP


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose group<br>Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration). | Drug: Cyproheptadine<br>* 3-month treatment<br>* Other names: Periactine®;Drug: Alpress LP<br>* 3-month treatment<br>* Other names: Prazosin;|
| Experimental: High-dose group<br>Periactine® (Cyproheptadine 12 mg/day; three times 4 mg: morning, noon and evening) and Alpress® (10 mg [2 tablets of 5 mg] once a day slow-release: evening administration) | Drug: Cyproheptadine<br>* 3-month treatment<br>* Other names: Periactine®;Drug: Alpress LP<br>* 3-month treatment<br>* Other names: Prazosin;|
| Placebo Comparator: Placebo group<br>Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening) | Drug: Cyproheptadine<br>* 3-month treatment<br>* Other names: Periactine®;Drug: Alpress LP<br>* 3-month treatment<br>* Other names: Prazosin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean quantity of alcohol consumed per day in the three groups |  | weeks 9 to 12 |