Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients (ALPADIR)
This study has been completed.
Sponsor:
Ethypharm
Information provided by (Responsible Party):
Ethypharm
ClinicalTrials.gov Identifier:
NCT01738282
First received: November 26, 2012
Last updated: July 29, 2014
Last verified: July 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence |
Drug: Baclofen Drug: Placebo (for baclofen) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicentric, Double Blind Study to Assess the Efficacy of Xylka® (Baclofen) at the Target Dosage of 180mg/Day Compared to Placebo, for Maintenance of Abstinence in Alcohol Dependent Patients |
Resource links provided by NLM:
MedlinePlus related topics:
Alcoholism and Alcohol Abuse
Drug Information available for:
Baclofen
U.S. FDA Resources
Further study details as provided by Ethypharm:
Primary Outcome Measures:
- Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168. [ Time Frame: Day 168 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: Day 168 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Day 210 ] [ Designated as safety issue: No ]
- Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence [ Time Frame: Day 168 ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Day 168 ] [ Designated as safety issue: No ]
- Drinking characteristics for patients having a relapse between Day 1 and Day 210 [ Time Frame: Day 210 ] [ Designated as safety issue: No ]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
- Change in craving, addiction and Quality of Life scales [ Time Frame: Day 210 ] [ Designated as safety issue: No ]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
- Recording of safety data [ Time Frame: Day 210 ] [ Designated as safety issue: Yes ]Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test
| Estimated Enrollment: | 316 |
| Study Start Date: | December 2012 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Baclofen
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
|
Drug: Baclofen |
|
Placebo Comparator: Placebo
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
|
Drug: Placebo (for baclofen) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients meeting DSM IV(Diagnosis and Statistical Manual of Mental Disorders, 4th edition) criteria for alcohol dependence
- Willing to participate in the study and express a desire to achieve the objective of continuous and long term abstinence after withdrawal
- Abstinent (last drinking) for a minimum of 3 days and maximum of 14 days
- At least one previous abstinence attempt
Exclusion Criteria:
- Need for a stay at the end of the withdrawal period in a health care and rehabilitation institution specialized in addiction
- Need for a heavy psychosocial out of hospital care
- History of baclofen intake, by prescription or self medication
- Porphyria
- Concomitant treatment with one or several drugs for the maintenance of abstinence
- Severe renal, cardiac or pulmonary disorder
- Epilepsy or history of epilepsy
- Concomitant treatment with psychotropic drugs, except antidepressants at stable dose for 2 months, diazepam and oxazepam
- Severe psychiatric disease (schizophrenia and bipolar disorder)
- Suicidal risk or history of suicide
- Clinically significant cognitive disorders
- Hepatic encephalopathy
- Ongoing dependence or within the last 12 months on other addictive substances (opioid, cocaine, cannabis, other substances or drugs…), excepted tobacco
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738282
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738282
Locations
| France | |
| Angers, France | |
| 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 | |
| L'Arbresle, France | |
| Centre hospitalier | |
| La Membrolle sur Choisille, France | |
| Hopital Michallon | |
| La Tronche, 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 | |
| Nimes, 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 Egreve, France | |
| Hopital René Muret | |
| Sevran, France | |
| CSAPA | |
| Seynod, France | |
| Centre hospitalier intercommunal | |
| Toulon, France | |
| Hopital Brabois | |
| Vandoeuvre les Nancy, France | |
| Hopital Paul Brousse | |
| Villejuif, France | |
Sponsors and Collaborators
Ethypharm
Investigators
| Principal Investigator: | Michel REYNAUD, MD | Villejuif, France |
More Information
| Responsible Party: | Ethypharm |
| ClinicalTrials.gov Identifier: | NCT01738282 History of Changes |
| Other Study ID Numbers: | ALP 2011007/002 |
| Study First Received: | November 26, 2012 |
| Last Updated: | July 29, 2014 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Keywords provided by Ethypharm:
|
baclofene Alcohol dependence Maintenance of abstinence |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 28, 2016