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

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ClinicalTrials.gov Identifier: NCT04108104
Recruitment Status : Active, not recruiting
First Posted : September 27, 2019
Last Update Posted : September 13, 2021
Sponsor:
Collaborator:
ECSOR
Information provided by (Responsible Party):
Greenpharma S.A.S. ( Kinnov Therapeutics )

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
Alcohol Use Disorder Drug: Cyproheptadine Drug: Alpress LP Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : November 30, 2019
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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 Name: Periactine®

Drug: Alpress LP
3-month treatment
Other Name: 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 Name: Periactine®

Drug: Alpress LP
3-month treatment
Other Name: 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 Name: Periactine®

Drug: Alpress LP
3-month treatment
Other Name: Prazosin




Primary Outcome Measures :
  1. Change in the mean quantity of alcohol consumed per day in the three groups [ Time Frame: weeks 9 to 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108104


Locations
Show Show 35 study locations
Sponsors and Collaborators
Kinnov Therapeutics
ECSOR
Investigators
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Study Director: Alain Puech Kinnov Therapeutics
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Responsible Party: Kinnov Therapeutics
ClinicalTrials.gov Identifier: NCT04108104    
Other Study ID Numbers: KT-100-001
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cyproheptadine
Prazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents