Clinical trial NCT04108104: Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Greenpharma S.A.S.
Sponsor class: OTHER
Collaborators: name: ECSOR
First posted: 2019-09-27
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in the mean quantity of alcohol consumed per day in the three groups
timeFrame: weeks 9 to 12
Secondary outcomes:
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Centre Hospitalier d'Abbeville
city: Agen
country: France
facility: Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie
city: Astillé
country: France
facility: clinique de la Bréhonnière
city: Bayonne
country: France
facility: Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque - Service d'addictologie
city: Bersée
country: France
facility: Cabinet Médical
city: Brest
country: France
facility: CHRU Brest - Hôpital Cavale Blanche
city: Brest
country: France
facility: HIA Clermont Tonnerre
city: Bron
country: France
facility: Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon - Service d'addictologie
city: La Couronne
country: France
facility: Centre Hospitalier Camille Claudel
city: La Rochelle
country: France
facility: Centre Hospitalier de La Rochelle
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile-Roux
city: Limoges
country: France
facility: Centre hospitalier Esquirol - Pôle d'addictologie en Limousin
city: Lyon
country: France
facility: Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse
city: Marseille
country: France
facility: CHU Provences-Alpes Côte d'Azur Hôpital Publique
city: Marseille
country: France
facility: Clinique Saint Barnabé
city: Montpellier
country: France
facility: Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques
city: Nancy
country: France
facility: Hôpital St-Julien
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu
city: Nice
country: France
facility: Centre Hospitalier universitaire de Nice - Hôpital Archet II
city: Nîmes
country: France
facility: Hôpital Universitaire Carémeau
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive
city: Orléans
country: France
facility: Centre Médico-Psychologique Saint-Marc
city: Paris
country: France
facility: Centre Hospitalier Sainte-Anne
city: Paris
country: France
facility: Hôpital Fernand-Widal
city: Pau
country: France
facility: Centre Hospitalier de Pau - Unité d'addictologie
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif
city: Saint-Martin-d'Hères
country: France
facility: Centre Ambulatoire de Santé Mentale
city: Saint-Nazaire
country: France
facility: Centre Hospitalier de Saint-Nazaire
city: Saint-Rémy
country: France
facility: Association Hospitalière de Bourgogne Franche-Comté
city: Tours
country: France
facility: cabinet médical du Dr El-Ayoubi
city: Épagny
country: France
facility: Centre Hospitalier Annecy Genevois
Study officials:
affiliation: Kinnov Therapeutics
name: Alain Puech
role: STUDY_DIRECTOR
References:
citation: 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.