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Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients (ALPADIR)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01738282

First Posted: November 30, 2012

Last Update Posted: July 30, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Ethypharm

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 Intervention Model: Parallel Assignment Masking: Double (Participant, 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 ]

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 ]
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 ]
Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence [ Time Frame: 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) [ Time Frame: Day 168 ]
Drinking characteristics for patients having a relapse between Day 1 and Day 210 [ Time Frame: 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
Change in craving, addiction and Quality of Life scales [ Time Frame: Day 210 ]
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 ]
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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): 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
First Submitted:	November 26, 2012
First Posted:	November 30, 2012
Last Update Posted:	July 30, 2014
Last Verified:	July 2014

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

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