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

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.
 
ClinicalTrials.gov Identifier: NCT01738282
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
Ethypharm

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alcohol Dependence Drug: Baclofen Drug: Placebo (for baclofen) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence [ Time Frame: Day 168 ]
  4. 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 ]
  5. 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

  6. 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

  7. Recording of safety data [ Time Frame: Day 210 ]
    Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Sponsors and Collaborators
Ethypharm
Investigators
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Principal Investigator: Michel REYNAUD, MD Villejuif, France
More Information
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Responsible Party: Ethypharm
ClinicalTrials.gov Identifier: NCT01738282    
Other Study ID Numbers: ALP 2011007/002
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Keywords provided by Ethypharm:
baclofene
Alcohol dependence
Maintenance of abstinence
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
 Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action