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Alcohol Use DisorderPhase 2COCKTAILNCT04108104

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

A Phase 2 study testing Cyproheptadine and Alpress LP in people with Alcohol Use Disorder, run by Kinnov Therapeutics at 35 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Cyproheptadine and Alpress LP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
35 sitesFrance
Study dates
30 Nov 2019to 31 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe alcohol use disorder
  • High-risk alcohol consumption

Who cannot join

  • 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
Show all 11Show fewer
  • History of bronchial asthma
  • History of uncontrolled hyperthyroidism
  • History of cardiovascular disease not under control
  • Severe psychiatric disorder
  • History of alcohol withdrawal syndrome

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

France35 sites

  • Centre Hospitalier d'Abbeville

    Abbeville

  • Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie

    Agen

  • clinique de la Bréhonnière

    Astillé

  • Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia

    Bayonne

  • Centre Hospitalier de la Côte Basque - Service d'addictologie

    Bayonne

  • Cabinet Médical

    Bersée

  • CHRU Brest - Hôpital Cavale Blanche

    Brest

  • HIA Clermont Tonnerre

    Brest

  • Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier

    Bron

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand

  • Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie

    Créteil

  • Centre Hospitalier Universitaire de Dijon - Service d'addictologie

    Dijon

  • Centre Hospitalier Annecy Genevois

    Épagny

  • Centre Hospitalier Camille Claudel

    La Couronne

  • Centre Hospitalier de La Rochelle

    La Rochelle

  • Centre Hospitalier Emile-Roux

    Le Puy-en-Velay

  • Centre hospitalier Esquirol - Pôle d'addictologie en Limousin

    Limoges

  • Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse

    Lyon

  • CHU Provences-Alpes Côte d'Azur Hôpital Publique

    Marseille

  • Clinique Saint Barnabé

    Marseille

  • Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques

    Montpellier

  • Hôpital St-Julien

    Nancy

  • Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu

    Nantes

  • Centre Hospitalier universitaire de Nice - Hôpital Archet II

    Nice

  • Hôpital Universitaire Carémeau

    Nîmes

  • Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive

    Orléans

  • Centre Médico-Psychologique Saint-Marc

    Orléans

  • Centre Hospitalier Sainte-Anne

    Paris

  • Hôpital Fernand-Widal

    Paris

  • Centre Hospitalier de Pau - Unité d'addictologie

    Pau

  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif

    Rennes

  • Centre Ambulatoire de Santé Mentale

    Saint-Martin-d'Hères

  • Centre Hospitalier de Saint-Nazaire

    Saint-Nazaire

  • Association Hospitalière de Bourgogne Franche-Comté

    Saint-Rémy

  • cabinet médical du Dr El-Ayoubi

    Tours

Other trials in France

About this study

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

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).

Being tested
Cyproheptadine, Alpress LP
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyproheptadineDrug

    Also called Periactine®

    3-month treatment

  • Alpress LPDrug

    Also called Prazosin

    3-month treatment

Study groups in NCT04108104
Study groupRoleWhat they receive
Low-dose groupExperimentalPeriactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
Receives: Drug: Cyproheptadine; Drug: Alpress LP
High-dose groupExperimentalPeriactine® (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)
Receives: Drug: Cyproheptadine; Drug: Alpress LP
Placebo groupPlacebo comparatorPlacebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
Receives: Drug: Cyproheptadine; Drug: Alpress LP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the mean quantity of alcohol consumed per day in the three groups

    Measured: weeks 9 to 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2019
  2. Study start30 Nov 2019
  3. Primary completion28 Oct 2021
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04108104
Sponsor's protocol ID
KT-100-001
Acronym
COCKTAIL
Status last verified
Apr 2024
First submitted
25 Sep 2019
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38597214

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyproheptadine and Alpress LP in people with Alcohol Use Disorder, run by Kinnov Therapeutics at 35 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the mean quantity of alcohol consumed per day in the three groups (time frame: weeks 9 to 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04108104, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.

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