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

Kinnov Therapeutics

Status and phase: Completed; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: Cyproheptadine; Drug: Alpress LP

Study type: Interventional

Funder types: Other

Identifiers

NCT04108104

KT-100-001

Details and patient eligibility

About

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).

Enrollment: 154 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 3 patient groups, including a placebo group

Low-dose group

Experimental group

Description:

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

Treatment:

Drug: Alpress LP

Drug: Cyproheptadine

High-dose group

Experimental group

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)

Treatment:

Drug: Alpress LP

Drug: Cyproheptadine

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Alpress LP

Drug: Cyproheptadine