NCT04108104 (COCKTAIL) is a Phase 2 clinical trial of Cyproheptadine in Alcohol Use Disorder, sponsored by Kinnov Therapeutics.

Who is sponsoring NCT04108104?

NCT04108104 is sponsored by Kinnov Therapeutics.

What drugs are being tested in NCT04108104?

Interventions in NCT04108104: Cyproheptadine, Alpress LP.

What condition does NCT04108104 study?

NCT04108104 studies Alcohol Use Disorder.

Is NCT04108104 still recruiting?

NCT04108104 is currently completed. Last updated 15 April 2024.

Last reviewed 2024-04-15 · How we verify

NCT04108104: COCKTAIL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 15 April 2024

What this trial tests

Phase 2 trial testing Cyproheptadine in Alcohol Use Disorder in 154 participants. Completed in 31 January 2022.

Timeline

30 November 2019

Primary endpoint
28 October 2021

31 January 2022

Quick facts

Lead sponsor	Kinnov Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	154
Start date	30 November 2019
Primary completion	28 October 2021
Estimated completion	31 January 2022
Sites	35 locations across France

Drugs / interventions tested

Cyproheptadine (CYPROHEPTADINE) — full drug profile →
Alpress LP — full drug profile →

Conditions studied

Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Kinnov Therapeutics — full company profile →

Who can join

Adults 18 to 65, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Comorbid alcohol and cannabis use disorders increase mortality in patients with eating disorders
Stryhn L, Mejldal A, Guala M, Støving R, et al · · 2022
An innovative combination of cypropheptadine and prazosin for the treatment of alcohol use disorder: a double-blind, randomised, parallel-group, three-arm, multicentre, placebo-controlled phase 2 trial
Aubin H, Puech A. · · 2022
The association between social media use and mental health among adolescents and young adults
Koronczai B, Demetrovics Z. · · 2022
Adverse childhood experience referring to parental relationship is associated with the risk of alcohol dependence and with COMT Val158Met polymorphism, but out of gene-environment interactions
Merkulova T, Chuprova N, Solovieva M, Nikolishin A, et al · · 2022

Verify or expand the search:

Other trials of Cyproheptadine

Trials testing the same drug.

NCT06751290 — The Use of Cyproheptadine in Pediatric Feeding Disorders · Phase 4 · active not recruiting
NCT06175273 — Pediatric Oncology Nutrition Intervention Trial · Phase 2, PHASE3 · completed
NCT04979221 — Effect of Cyproheptadine on Ventilatory Support-free Days in Critically Ill Patients With COVID-19 · Phase 3 · unknown
NCT04488081 — I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients · Phase 2 · active not recruiting

Other recruiting trials for Alcohol Use Disorder

Currently open trials in the same condition.

NCT06860607 — Environment and Alcohol: A Pilot Study · Phase 1 · recruiting
NCT07325266 — Human Laboratory Study of Apremilast for Alcohol Use Disorder · Phase 2 · recruiting
NCT07046819 — Tirzepatide in MetALD · Phase 2 · recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
NCT07056894 — Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis · NA · recruiting

Other Kinnov Therapeutics trials

Trials by the same sponsor.

NCT06147622 — A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04108104 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kinnov Therapeutics
Last refreshed: 15 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04108104.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing