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The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baclofen | Experimental | Baclofen 20mg tablet. Titration:increasing dosage regimen to reach the target dosage of 180 mg (9 tablets)in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks |
|
| Placebo | Placebo Comparator | Placebo tablet Titration:increasing dosage regimen to reach the target dosage of 9 tablets in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug |
| ||
| Placebo (for baclofen) |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168. | Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of the maintenance dose period (Day 168), i.e. 24 weeks | Day 168 | |
| Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of 4-week post treatment follow up period (Day 210), i.e. 30 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel REYNAUD, MD | Villejuif, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33012365 | Derived | Braillon A, Naudet F. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean. Mayo Clin Proc. 2020 Oct;95(10):2294-2295. doi: 10.1016/j.mayocp.2020.08.005. No abstract available. |
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|
| Day 210 |
| Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence | Day 168 |
| Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the level of drinking before withdrawal (Time Line Follow Back calendar/ World Health Organization criteria for risk of consumption) | Day 168 |
| Drinking characteristics for patients having a relapse between Day 1 and Day 210 | Time to relapse (Day 1 to first drinking day) Time to relapse to first high risk drinking day (>60g for a male, > 40g for a female) Percentage of drinking days from Day 1 to Day 210 Mean number of standard drinks per drinking day and classification according to World Health Organization criteria for the risk of consumption Percentage of high risk drinking days during the maintenance period at the target dosage (Day 50 to Day 168) compared to the percentage of high risk drinking days during the preceding 4 weeks of the withdrawal Percentage of drinking days during the maintenance period at the target dosage (Day 50 to Day 168) compared to the percentage of drinking days during the preceding 4 weeks of the withdrawal | Day 210 |
| Change in craving, addiction and Quality of Life scales | Clinical Global Impression (CGI), Alcohol dependence Quality of Life (AlQoL9), Obsessive Compulsive Drinking Scale (OCDS), Hospital Anxiety and Depression Scale (HAD), Visual Analogue Scale (VAS) craving scores and liver biomarkers | Day 210 |
| Recording of safety data | Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test | Day 210 |
| Bron |
| France |
| Clermont de l'Oise | France |
| CHU | Clermont-Ferrand | France |
| Hopital Beaujon | Clichy | France |
| Dax | France |
| Centre hospitalier | Dijon | France |
| Centre hospitalier | Erstein | France |
| Centre hospitalier | La Membrolle-sur-Choisille | France |
| Hopital Michallon | La Tronche | France |
| LArbresle | France |
| Centre hospitalier | Le Mans | France |
| CHRU | Lille | France |
| CSAPA | Lille | France |
| Limoges | France |
| Hopital de la Croix Rousse | Lyon | France |
| Hopital Sainte Marguerite | Marseille | France |
| Centre hospitalier | Montauban | France |
| Morlaix | France |
| Hopital Villemin | Nancy | France |
| CHU | Nantes | France |
| Centre hospitalier | Nice | France |
| CHRU | Nîmes | France |
| Hopital Bichat Claude Bernard | Paris | France |
| Hopital Cochin | Paris | France |
| Hopital Fernand Widal | Paris | France |
| Hopital Saint Anne | Paris | France |
| Centre hospitalier | Perpignan | France |
| Centre hospitalier | Pont-du-Casse | France |
| Reims | France |
| Hopital Pontchaillou | Rennes | France |
| Hopital de la Fraternité | Roubaix | France |
| Saint-Égrève | France |
| Hopital René Muret | Sevran | France |
| CSAPA | Seynod | France |
| Centre hospitalier intercommunal | Toulon | France |
| Hopital Brabois | Vandœuvre-lès-Nancy | France |
| Hopital Paul Brousse | Villejuif | 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 |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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