Trial | NCT04108104  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    154
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 Started
Nov 30
2019
Primary Completion
Oct 28
2021
Study Completion
Jan 31
2022
Last Update
Jan 20
2023

Drug Alpress LP

3-month treatment

  • Other names: Prazosin

Drug Cyproheptadine

3-month treatment

  • Other names: Periactine®

Low-dose group Experimental

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

High-dose group Experimental

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 group Placebo Comparator

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

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
No Results Posted