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| Name | Class |
|---|---|
| ECSOR | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyproheptadine | Drug | 3-month treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean quantity of alcohol consumed per day in the three groups | weeks 9 to 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Puech | Kinnov Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Abbeville | Abbeville | France | ||||
| Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38597214 | Result | 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. |
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| Alpress LP | Drug | 3-month treatment |
|
|
| 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 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D011224 | Prazosin |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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