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BACLAD: Baclofen for the Treatment of Alcohol Dependence

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT01266655
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
38.9
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Baclofen for the Treatment of Alcohol Dependence - BACLAD
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Total abstinence from alcohol and cumulative abstinence duration [13-16 weeks (depending on the individually tolerated baclofen dose)]

Secondary Outcome Measures

  1. Number of adverse events [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01266655
Other Study ID Numbers:
  • BACLAD
First Posted:
Dec 24, 2010
Last Update Posted:
Sep 5, 2014
Last Verified:
Sep 1, 2014
Additional relevant MeSH terms:
Alcoholism
Baclofen

Study Results

No Results Posted as of Sep 5, 2014