Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects (COCKTAIL)
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| ClinicalTrials.gov Identifier: NCT04108104 |
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Recruitment Status :
Completed
First Posted : September 27, 2019
Last Update Posted : January 20, 2023
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcohol Use Disorder | Drug: Cyproheptadine Drug: Alpress LP | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 154 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | November 30, 2019 |
| Actual Primary Completion Date : | October 28, 2021 |
| Actual Study Completion Date : | January 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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).
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Drug: Cyproheptadine
3-month treatment
Other Name: Periactine® Drug: Alpress LP 3-month treatment
Other Name: Prazosin |
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Experimental: 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)
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Drug: Cyproheptadine
3-month treatment
Other Name: Periactine® Drug: Alpress LP 3-month treatment
Other Name: Prazosin |
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Placebo Comparator: Placebo group
Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
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Drug: Cyproheptadine
3-month treatment
Other Name: Periactine® Drug: Alpress LP 3-month treatment
Other Name: Prazosin |
- Change in the mean quantity of alcohol consumed per day in the three groups [ Time Frame: weeks 9 to 12 ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108104
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| Study Director: | Alain Puech | Kinnov Therapeutics |
| Responsible Party: | Kinnov Therapeutics |
| ClinicalTrials.gov Identifier: | NCT04108104 |
| Other Study ID Numbers: |
KT-100-001 |
| First Posted: | September 27, 2019 Key Record Dates |
| Last Update Posted: | January 20, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Alcoholism Alcohol Drinking Drinking Behavior Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cyproheptadine Prazosin Antihypertensive Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipruritics Dermatologic Agents Gastrointestinal Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Serotonin Antagonists Serotonin Agents Anti-Allergic Agents |