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

Phase 2

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Cyproheptadine; Drug: Alpress LP

• Registration Number: NCT04108104
• Lead Sponsor: Kinnov Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Study Start: 2019-11-30
• Primary Completion: 2021-10-28
• Study Completion: 2022-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose group	Alpress LP	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)
Low-dose group	Alpress LP	Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
Placebo group	Alpress LP	Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
Low-dose group	Cyproheptadine	Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
High-dose group	Cyproheptadine	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)
Placebo group	Cyproheptadine	Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)

Primary Outcome Measures

Name	Time	Method
Change in the mean quantity of alcohol consumed per day in the three groups	weeks 9 to 12

Trial Locations

Locations (35)

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

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

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