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Baclofen for the Treatment of Alcohol Dependence (BACLAD)

This study has been completed.
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: December 23, 2010
Last updated: September 4, 2014
Last verified: September 2014
There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.

Condition Intervention Phase
Alcohol Dependence Drug: Baclofen Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Baclofen for the Treatment of Alcohol Dependence - BACLAD

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Total abstinence from alcohol and cumulative abstinence duration [ Time Frame: 13-16 weeks (depending on the individually tolerated baclofen dose) ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 24 weeks ]

Enrollment: 56
Study Start Date: February 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baclofen Drug: Baclofen
Baclofen will be administered orally for a maximum of 20 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams t.i.d.; subsequently, the daily dose of baclofen will be increased to a maximum of 90 milligrams t.i.d. within 4 weeks. In case of intolerance, dosage can be decreased to a minimum of 10 mg t.i.d.. Patients will receive maximum tolerated dosage of baclofen for 12 weeks. Medication will then gradually be tapered over a maximum of 4 weeks.
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of alcohol dependence according to ICD-10 (International Classification of Mental and Behavioural Disorders, 10th revision) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th revision) criteria
  • An alcohol intake of at least two heavy drinking days per week on average (men ≥ 5 drinks per day; women ≥ 4 drinks per day) and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification (one standard drink is equal to 12 g absolute alcohol)
  • Last alcohol consumption within 7-21 days before randomisation
  • Sufficient German language capabilities

Exclusion Criteria:

  • Pregnancy and/or currently breastfeeding
  • Clinical significant medical conditions or observed abnormalities
  • Psychiatric illness undergoing treatment with psychoactive drugs
  • Epilepsy or epileptiform convulsions
  • Addiction to drugs other than nicotine
  Contacts and Locations
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Please refer to this study by its identifier: NCT01266655

Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Andreas Heinz, Prof., M.D. Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Germany
  More Information

Responsible Party: Prof. A. Heinz, M.D., Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin Identifier: NCT01266655     History of Changes
Other Study ID Numbers: BACLAD
Study First Received: December 23, 2010
Last Updated: September 4, 2014

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders processed this record on July 21, 2017