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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ethypharm
ClinicalTrials.gov Identifier:
NCT01738282
First received: November 26, 2012
Last updated: January 8, 2014
Last verified: January 2014
  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:


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
Estimated Study Completion Date: July 2014
Estimated 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
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

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
CSAPA
Lille, France
CHRU
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 Fernand Widal
Paris, France
Hopital Cochin
Paris, France
Hopital Bichat Claude Bernard
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

No publications provided

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: January 8, 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
Mental Disorders
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014