Baclofen for the Treatment of Alcohol Dependence (BACLAD)

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01266655
First received: December 23, 2010
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266655

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

No publications provided

Responsible Party: Prof. A. Heinz, M.D., Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT01266655     History of Changes
Other Study ID Numbers: BACLAD
Study First Received: December 23, 2010
Last Updated: September 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 29, 2014