Baclofen for the Treatment of Alcohol Dependence

Alcohol Dependence Clinical Trial

— BACLAD  

Official title:

Baclofen for the Treatment of Alcohol Dependence - BACLAD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266655
• Other study ID #: BACLAD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 23, 2010
• Last updated: September 4, 2014
• Start date: February 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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
Placebo

Locations

Country	Name	City	State
Germany	Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total abstinence from alcohol and cumulative abstinence duration		13-16 weeks (depending on the individually tolerated baclofen dose)	No
Secondary	Number of adverse events		24 weeks	Yes