Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects
NCT ID: NCT04108104
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2019-11-30
2022-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Medication Prazosin for Alcohol Dependence
NCT00762710
Prazosin Alcohol Dependence IVR Study
NCT00167687
PT150 Drug for Use in Alcohol Use Disorder
NCT06712602
Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
NCT04793685
Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin
NCT01916941
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
Cyproheptadine
3-month treatment
Alpress LP
3-month treatment
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)
Cyproheptadine
3-month treatment
Alpress LP
3-month treatment
Placebo group
Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
Cyproheptadine
3-month treatment
Alpress LP
3-month treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cyproheptadine
3-month treatment
Alpress LP
3-month treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* High-risk alcohol consumption
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ECSOR
UNKNOWN
Kinnov Therapeutics
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alain Puech
Role: STUDY_DIRECTOR
Kinnov Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier d'Abbeville
Abbeville, , France
Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie
Agen, , France
clinique de la Bréhonnière
Astillé, , France
Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia
Bayonne, , France
Centre Hospitalier de la Côte Basque - Service d'addictologie
Bayonne, , France
Cabinet Médical
Bersée, , France
CHRU Brest - Hôpital Cavale Blanche
Brest, , France
HIA Clermont Tonnerre
Brest, , France
Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier
Bron, , France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, , France
Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie
Créteil, , France
Centre Hospitalier Universitaire de Dijon - Service d'addictologie
Dijon, , France
Centre Hospitalier Annecy Genevois
Épagny, , France
Centre Hospitalier Camille Claudel
La Couronne, , France
Centre Hospitalier de La Rochelle
La Rochelle, , France
Centre Hospitalier Emile-Roux
Le Puy-en-Velay, , France
Centre hospitalier Esquirol - Pôle d'addictologie en Limousin
Limoges, , France
Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse
Lyon, , France
CHU Provences-Alpes Côte d'Azur Hôpital Publique
Marseille, , France
Clinique Saint Barnabé
Marseille, , France
Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques
Montpellier, , France
Hôpital St-Julien
Nancy, , France
Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu
Nantes, , France
Centre Hospitalier universitaire de Nice - Hôpital Archet II
Nice, , France
Hôpital Universitaire Carémeau
Nîmes, , France
Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive
Orléans, , France
Centre Médico-Psychologique Saint-Marc
Orléans, , France
Centre Hospitalier Sainte-Anne
Paris, , France
Hôpital Fernand-Widal
Paris, , France
Centre Hospitalier de Pau - Unité d'addictologie
Pau, , France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif
Rennes, , France
Centre Ambulatoire de Santé Mentale
Saint-Martin-d'Hères, , France
Centre Hospitalier de Saint-Nazaire
Saint-Nazaire, , France
Association Hospitalière de Bourgogne Franche-Comté
Saint-Rémy, , France
cabinet médical du Dr El-Ayoubi
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Aubin HJ, Berlin I, Guiraud J, Bruhwyler J, Batel P, Perney P, Trojak B, Bendimerad P, Guillou M, Bisch M, Grall-Bronnec M, Labarriere D, Delsart D, Questel F, Moirand R, Bernard P, Trovero F, Pham HP, Tassin JP, Puech A. Prazosin and cyproheptadine in combination in the treatment of alcohol use disorder: A randomized, double-blind, placebo-controlled trial. Addiction. 2024 Jul;119(7):1211-1223. doi: 10.1111/add.16484. Epub 2024 Apr 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KT-100-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.