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Baclofen for the Treatment of Alcohol Dependence (BACLAD)

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ClinicalTrials.gov Identifier: NCT01266655
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : September 5, 2014
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE December 23, 2010
First Posted Date  ICMJE December 24, 2010
Last Update Posted Date September 5, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2010)
Total abstinence from alcohol and cumulative abstinence duration [ Time Frame: 13-16 weeks (depending on the individually tolerated baclofen dose) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
Number of adverse events [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2010)
Tolerability and safety of the study medication [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baclofen for the Treatment of Alcohol Dependence
Official Title  ICMJE Baclofen for the Treatment of Alcohol Dependence - BACLAD
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Baclofen
    Intervention: Drug: Baclofen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Beck A, Pelz P, Lorenz RC, Charlet K, Geisel O, Heinz A, Wüstenberg T, Müller CA. Effects of high-dose baclofen on cue reactivity in alcohol dependence: A randomized, placebo-controlled pharmaco-fMRI study. Eur Neuropsychopharmacol. 2018 Nov;28(11):1206-1216. doi: 10.1016/j.euroneuro.2018.08.507. Epub 2018 Sep 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2010)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01266655
Other Study ID Numbers  ICMJE BACLAD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. A. Heinz, M.D., Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Heinz, Prof., M.D. Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP