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Completed

NCT Number: NCT01738282

Efficacy and Safety of Baclofen 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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen

Drug

Placebo (for baclofen)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ethypharm

Industry

Registry information

Official study 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

Acronym: ALPADIR

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2012
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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