Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients (ALPADIR)
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| ClinicalTrials.gov Identifier: NCT01738282 |
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Recruitment Status :
Completed
First Posted : November 30, 2012
Last Update Posted : July 30, 2014
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Sponsor:
Ethypharm
Information provided by (Responsible Party):
Ethypharm
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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 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
MedlinePlus related topics:
Alcohol Use Disorder (AUD)
Drug Information available for:
Baclofen
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Baclofen |
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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
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Drug: Placebo (for baclofen) |
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 ]
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 ]
- 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
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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
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
Show 38 study locations
Sponsors and Collaborators
Ethypharm
Investigators
| Principal Investigator: | Michel REYNAUD, MD | Villejuif, France |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |