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

Sponsor
Kinnov Therapeutics (Other)
Overall Status
Completed
CT.gov ID
NCT04108104
Collaborator
ECSOR (Other)
154
Enrollment
35
Locations
3
Arms
26.1
Actual Duration (Months)
4.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
154 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 30, 2019
Actual Primary Completion Date :
Oct 28, 2021
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low-dose group

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
3-month treatment
Other Names:
  • Periactine®

    • Drug: Alpress LP
    3-month treatment
    Other Names:
  • Prazosin

    		•
    Experimental: High-dose group

    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
    3-month treatment
    Other Names:
  • Periactine®

    • Drug: Alpress LP
    3-month treatment
    Other Names:
  • Prazosin

    		•
    Placebo Comparator: Placebo group

    Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)

    Drug: Cyproheptadine
    3-month treatment
    Other Names:
  • Periactine®

    • Drug: Alpress LP
    3-month treatment
    Other Names:
  • Prazosin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the mean quantity of alcohol consumed per day in the three groups [weeks 9 to 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier d'Abbeville Abbeville France
    2 Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie Agen France
    3 clinique de la Bréhonnière Astillé France
    4 Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia Bayonne France
    5 Centre Hospitalier de la Côte Basque - Service d'addictologie Bayonne France
    6 Cabinet Médical Bersée France
    7 CHRU Brest - Hôpital Cavale Blanche Brest France
    8 HIA Clermont Tonnerre Brest France
    9 Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier Bron France
    10 Centre Hospitalier Universitaire de Clermont-Ferrand Clermont-Ferrand France
    11 Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie Créteil France
    12 Centre Hospitalier Universitaire de Dijon - Service d'addictologie Dijon France
    13 Centre Hospitalier Camille Claudel La Couronne France
    14 Centre Hospitalier de La Rochelle La Rochelle France
    15 Centre Hospitalier Emile-Roux Le Puy-en-Velay France
    16 Centre hospitalier Esquirol - Pôle d'addictologie en Limousin Limoges France
    17 Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse Lyon France
    18 CHU Provences-Alpes Côte d'Azur Hôpital Publique Marseille France
    19 Clinique Saint Barnabé Marseille France
    20 Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques Montpellier France
    21 Hôpital St-Julien Nancy France
    22 Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu Nantes France
    23 Centre Hospitalier universitaire de Nice - Hôpital Archet II Nice France
    24 Hôpital Universitaire Carémeau Nîmes France
    25 Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive Orléans France
    26 Centre Médico-Psychologique Saint-Marc Orléans France
    27 Centre Hospitalier Sainte-Anne Paris France
    28 Hôpital Fernand-Widal Paris France
    29 Centre Hospitalier de Pau - Unité d'addictologie Pau France
    30 Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif Rennes France
    31 Centre Ambulatoire de Santé Mentale Saint-Martin-d'Hères France
    32 Centre Hospitalier de Saint-Nazaire Saint-Nazaire France
    33 Association Hospitalière de Bourgogne Franche-Comté Saint-Rémy France
    34 cabinet médical du Dr El-Ayoubi Tours France
    35 Centre Hospitalier Annecy Genevois Épagny France

    Sponsors and Collaborators

    • Kinnov Therapeutics
    • ECSOR

    Investigators

    • Study Director: Alain Puech, Kinnov Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kinnov Therapeutics
    ClinicalTrials.gov Identifier:
    NCT04108104
    Other Study ID Numbers:
    • KT-100-001
    First Posted:
    Sep 27, 2019
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alcoholism
    Alcohol Drinking
    Cyproheptadine
    Prazosin

    Study Results

    No Results Posted as of Mar 15, 2022