Baclofen for the Treatment of Alcohol Dependence - BACLAD
- Conditions
- Alcohol Dependence
- Registration Number
- EUCTR2010-021861-62-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Alcohol dependence according to ICD-10 and DSM-IV
- Age 18 to < 65 years
- Males and females
- Alcohol consumption of a minimum of 2 severe drinking days per week in average (defined as = 5 drinks per day for males and = 4 drinks per day for females) as well as an average comsumtion of 21 drinks or more per week for males and 14 drinks or more per week for females in the last 4 weeks before detoxication
- last alcohol comsumption within the last 7-21 days before randomisation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
- Pregnancy and/or lactation
- Clinically significant internal, psychiatric or neurological disorders
- Psychiatric disorders which are treated with psychoactive substances
- Epilepsy or epileptiform seizures
- Known intolerabilty of baclofen or another component
- Terminal renal insufficiency
- Other addictive disorders (besides nicotine)
- Gastroinstestinal ulcera
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of baclofen in alcohol dependence.<br><br>Primary outcome: total abstinence and cumulative abstinence duration within 12 weeks of treatment (individually maximum tolerated dose) - in comparison to placebo;Secondary Objective: Secondary outcomes:<br>- Safety and tolerability<br>- Drop-out rate<br>- Changes in psychiatric measures such as depressivity, anxiety, craving ;Primary end point(s): Primary outcome: total abstinence and cumulative abstinence duration within 12 weeks of treatment (individually maximum tolerated dose) - in comparison to placebo
- Secondary Outcome Measures
Name Time Method