Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects
COCKTAIL
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
1 other identifier
interventional
154
1 country
35
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2019
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
November 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedApril 15, 2024
April 1, 2024
1.9 years
September 25, 2019
April 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the mean quantity of alcohol consumed per day in the three groups
weeks 9 to 12
Study Arms (3)
Low-dose group
EXPERIMENTALPeriactine® (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
EXPERIMENTALPeriactine® (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
PLACEBO COMPARATORPlacebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
Interventions
3-month treatment
Eligibility Criteria
You may qualify if:
- Severe alcohol use disorder
- High-risk alcohol consumption
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kinnov Therapeuticslead
- ECSORcollaborator
Study Sites (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
Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie
Créteil, France
Centre Hospitalier Universitaire de Dijon - Service d'addictologie
Dijon, France
Centre Hospitalier Annecy Genevois
Épagny, France
Centre Hospitalier Camille Claudel
La Couronne, France
Centre Hospitalier de La Rochelle
La Rochelle, France
Centre Hospitalier Emile-Roux
Le Puy-en-Velay, France
Centre hospitalier Esquirol - Pôle d'addictologie en Limousin
Limoges, France
Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse
Lyon, France
CHU Provences-Alpes Côte d'Azur Hôpital Publique
Marseille, France
Clinique Saint Barnabé
Marseille, France
Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques
Montpellier, France
Hôpital St-Julien
Nancy, France
Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu
Nantes, France
Centre Hospitalier universitaire de Nice - Hôpital Archet II
Nice, France
Hôpital Universitaire Carémeau
Nîmes, France
Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive
Orléans, France
Centre Médico-Psychologique Saint-Marc
Orléans, France
Centre Hospitalier Sainte-Anne
Paris, France
Hôpital Fernand-Widal
Paris, France
Centre Hospitalier de Pau - Unité d'addictologie
Pau, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif
Rennes, France
Centre Ambulatoire de Santé Mentale
Saint-Martin-d'Hères, France
Centre Hospitalier de Saint-Nazaire
Saint-Nazaire, France
Association Hospitalière de Bourgogne Franche-Comté
Saint-Rémy, France
cabinet médical du Dr El-Ayoubi
Tours, France
Related Publications (1)
Aubin HJ, Berlin I, Guiraud J, Bruhwyler J, Batel P, Perney P, Trojak B, Bendimerad P, Guillou M, Bisch M, Grall-Bronnec M, Labarriere D, Delsart D, Questel F, Moirand R, Bernard P, Trovero F, Pham HP, Tassin JP, Puech A. Prazosin and cyproheptadine in combination in the treatment of alcohol use disorder: A randomized, double-blind, placebo-controlled trial. Addiction. 2024 Jul;119(7):1211-1223. doi: 10.1111/add.16484. Epub 2024 Apr 10.
PMID: 38597214RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alain Puech
Kinnov Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2019
First Posted
September 27, 2019
Study Start
November 30, 2019
Primary Completion
October 28, 2021
Study Completion
January 31, 2022
Last Updated
April 15, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share