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Baclofen for the Treatment of Alcohol Dependence (BACLAD)

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Baclofen
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Baclofen

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Total abstinence from alcohol and cumulative abstinence duration

Secondary Outcome Measures

Number of adverse events

Full Information

First Posted
December 23, 2010
Last Updated
September 4, 2014
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01266655
Brief Title
Baclofen for the Treatment of Alcohol Dependence
Acronym
BACLAD
Official Title
Baclofen for the Treatment of Alcohol Dependence - BACLAD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baclofen
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Total abstinence from alcohol and cumulative abstinence duration
Time Frame
13-16 weeks (depending on the individually tolerated baclofen dose)
Secondary Outcome Measure Information:
Title
Number of adverse events
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Heinz, Prof., M.D.
Organizational Affiliation
Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30217552
Citation
Beck A, Pelz P, Lorenz RC, Charlet K, Geisel O, Heinz A, Wustenberg T, Muller 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.
Results Reference
derived

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Baclofen for the Treatment of Alcohol Dependence

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