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

Alcohol Dependence Clinical Trial

— ALPADIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738282
• Other study ID #: ALP 2011007/002
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2012
• Last updated: July 29, 2014
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Ethypharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Baclofen

• Placebo (for baclofen)

Locations

Country	Name	City	State
France	CHU	Clermont Ferrand
France	Hopital Beaujon	Clichy
France	Centre hospitalier	Dijon
France	Centre hospitalier	Erstein
France	Centre hospitalier	La Membrolle sur Choisille
France	Hopital Michallon	La Tronche
France	Centre hospitalier	Le Mans
France	CHRU	Lille
France	CSAPA	Lille
France	Hopital de la Croix Rousse	Lyon
France	Hopital Sainte Marguerite	Marseille
France	Centre hospitalier	Montauban
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	Hopital Pontchaillou	Rennes
France	Hopital de la Fraternité	Roubaix
France	Hopital René Muret	Sevran
France	CSAPA	Seynod
France	Centre hospitalier intercommunal	Toulon
France	Hopital Brabois	Vandoeuvre les Nancy
France	Hopital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Ethypharm

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168.		Day 168	No
Secondary	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		Day 168	No
Secondary	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		Day 210	No
Secondary	Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence		Day 168	No
Secondary	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)		Day 168	No
Secondary	Drinking characteristics for patients having a relapse between Day 1 and 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	Day 210	No
Secondary	Change in craving, addiction and Quality of Life scales	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	Day 210	No
Secondary	Recording of safety data	Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test	Day 210	Yes