ClinicalTrials.gov
ClinicalTrials.gov Menu

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

November 26, 2012
November 30, 2012
July 30, 2014
December 2012
July 2014   (Final data collection date for primary outcome measure)
Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168. [ Time Frame: Day 168 ]
Same as current
Complete list of historical versions of study NCT01738282 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alcohol Dependence
  • Drug: Baclofen
  • Drug: Placebo (for baclofen)
  • 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
    Intervention: 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
    Intervention: Drug: Placebo (for baclofen)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
Same as current
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01738282
ALP 2011007/002
Yes
Not Provided
Not Provided
Ethypharm
Ethypharm
Not Provided
Principal Investigator: Michel REYNAUD, MD Villejuif, France
Ethypharm
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP