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

Alcohol Use Disorder Clinical Trial

— COCKTAIL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108104
• Other study ID #: KT-100-001
• Status: Completed
• Phase: Phase 2
• Start date: November 30, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2024
• Source: Greenpharma S.A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: January 31, 2022
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Cyproheptadine
3-month treatment
• Alpress LP
3-month treatment

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Kinnov Therapeutics	ECSOR

Country where clinical trial is conducted

France, 

References & 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 co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the mean quantity of alcohol consumed per day in the three groups		weeks 9 to 12