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

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Cyproheptadine
Alpress LP
Sponsored by
Kinnov Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low-dose group

High-dose group

Placebo group

Arm Description

Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).

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)

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

Outcomes

Primary Outcome Measures

Change in the mean quantity of alcohol consumed per day in the three groups

Secondary Outcome Measures

Full Information

First Posted
September 25, 2019
Last Updated
January 19, 2023
Sponsor
Kinnov Therapeutics
Collaborators
ECSOR
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1. Study Identification

Unique Protocol Identification Number
NCT04108104
Brief Title
Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinnov Therapeutics
Collaborators
ECSOR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose group
Arm Type
Experimental
Arm Description
Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
Arm Title
High-dose group
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
Intervention Type
Drug
Intervention Name(s)
Cyproheptadine
Other Intervention Name(s)
Periactine®
Intervention Description
3-month treatment
Intervention Type
Drug
Intervention Name(s)
Alpress LP
Other Intervention Name(s)
Prazosin
Intervention Description
3-month treatment
Primary Outcome Measure Information:
Title
Change in the mean quantity of alcohol consumed per day in the three groups
Time Frame
weeks 9 to 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Puech
Organizational Affiliation
Kinnov Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier d'Abbeville
City
Abbeville
Country
France
Facility Name
Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie
City
Agen
Country
France
Facility Name
clinique de la Bréhonnière
City
Astillé
Country
France
Facility Name
Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia
City
Bayonne
Country
France
Facility Name
Centre Hospitalier de la Côte Basque - Service d'addictologie
City
Bayonne
Country
France
Facility Name
Cabinet Médical
City
Bersée
Country
France
Facility Name
CHRU Brest - Hôpital Cavale Blanche
City
Brest
Country
France
Facility Name
HIA Clermont Tonnerre
City
Brest
Country
France
Facility Name
Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier
City
Bron
Country
France
Facility Name
Centre Hospitalier Universitaire de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie
City
Créteil
Country
France
Facility Name
Centre Hospitalier Universitaire de Dijon - Service d'addictologie
City
Dijon
Country
France
Facility Name
Centre Hospitalier Camille Claudel
City
La Couronne
Country
France
Facility Name
Centre Hospitalier de La Rochelle
City
La Rochelle
Country
France
Facility Name
Centre Hospitalier Emile-Roux
City
Le Puy-en-Velay
Country
France
Facility Name
Centre hospitalier Esquirol - Pôle d'addictologie en Limousin
City
Limoges
Country
France
Facility Name
Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse
City
Lyon
Country
France
Facility Name
CHU Provences-Alpes Côte d'Azur Hôpital Publique
City
Marseille
Country
France
Facility Name
Clinique Saint Barnabé
City
Marseille
Country
France
Facility Name
Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques
City
Montpellier
Country
France
Facility Name
Hôpital St-Julien
City
Nancy
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu
City
Nantes
Country
France
Facility Name
Centre Hospitalier universitaire de Nice - Hôpital Archet II
City
Nice
Country
France
Facility Name
Hôpital Universitaire Carémeau
City
Nîmes
Country
France
Facility Name
Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive
City
Orléans
Country
France
Facility Name
Centre Médico-Psychologique Saint-Marc
City
Orléans
Country
France
Facility Name
Centre Hospitalier Sainte-Anne
City
Paris
Country
France
Facility Name
Hôpital Fernand-Widal
City
Paris
Country
France
Facility Name
Centre Hospitalier de Pau - Unité d'addictologie
City
Pau
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif
City
Rennes
Country
France
Facility Name
Centre Ambulatoire de Santé Mentale
City
Saint-Martin-d'Hères
Country
France
Facility Name
Centre Hospitalier de Saint-Nazaire
City
Saint-Nazaire
Country
France
Facility Name
Association Hospitalière de Bourgogne Franche-Comté
City
Saint-Rémy
Country
France
Facility Name
cabinet médical du Dr El-Ayoubi
City
Tours
Country
France
Facility Name
Centre Hospitalier Annecy Genevois
City
Épagny
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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