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

April 12, 2024 updated by: Kinnov Therapeutics

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France
        • Centre Hospitalier d'Abbeville
      • Agen, France
        • Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie
      • Astillé, France
        • clinique de la Bréhonnière
      • Bayonne, France
        • Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia
      • Bayonne, France
        • Centre Hospitalier de la Côte Basque - Service d'addictologie
      • Bersée, France
        • Cabinet Médical
      • Brest, France
        • CHRU Brest - Hôpital Cavale Blanche
      • Brest, France
        • HIA Clermont Tonnerre
      • Bron, France
        • Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier
      • Clermont-Ferrand, France
        • Centre Hospitalier Universitaire de Clermont-Ferrand
      • Créteil, France
        • Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie
      • Dijon, France
        • Centre Hospitalier Universitaire de Dijon - Service d'addictologie
      • La Couronne, France
        • Centre Hospitalier Camille Claudel
      • La Rochelle, France
        • Centre Hospitalier de La Rochelle
      • Le Puy-en-Velay, France
        • Centre Hospitalier Emile-Roux
      • Limoges, France
        • Centre hospitalier Esquirol - Pôle d'addictologie en Limousin
      • Lyon, France
        • Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse
      • Marseille, France
        • CHU Provences-Alpes Côte d'Azur Hôpital Publique
      • Marseille, France
        • Clinique Saint Barnabé
      • Montpellier, France
        • Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques
      • Nancy, France
        • Hôpital St-Julien
      • Nantes, France
        • Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu
      • Nice, France
        • Centre Hospitalier universitaire de Nice - Hôpital Archet II
      • Nîmes, France
        • Hôpital Universitaire Carémeau
      • Orléans, France
        • Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive
      • Orléans, France
        • Centre Médico-Psychologique Saint-Marc
      • Paris, France
        • Centre Hospitalier Sainte-Anne
      • Paris, France
        • Hôpital Fernand-Widal
      • Pau, France
        • Centre Hospitalier de Pau - Unité d'addictologie
      • Rennes, France
        • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif
      • Saint-Martin-d'Hères, France
        • Centre Ambulatoire de Santé Mentale
      • Saint-Nazaire, France
        • Centre Hospitalier de Saint-Nazaire
      • Saint-Rémy, France
        • Association Hospitalière de Bourgogne Franche-Comté
      • Tours, France
        • cabinet médical du Dr El-Ayoubi
      • Épagny, France
        • Centre Hospitalier Annecy Genevois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the mean quantity of alcohol consumed per day in the three groups
Time Frame: weeks 9 to 12
weeks 9 to 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinnov Therapeutics

Collaborators

ECSOR

Investigators

  • Study Director: Alain Puech, Kinnov Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2019

Primary Completion (Actual)

October 28, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KT-100-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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