EUCTR2010-021861-62-DE
Active, not recruiting
Not Applicable
Baclofen for the Treatment of Alcohol Dependence - BACLAD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Charité - Universitätsmedizin Berlin
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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)
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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