High-dose baclofen for the treatment of alcohol addiction.
Completed
- Conditions
- alcohol dependence (AD)
- Registration Number
- NL-OMON22245
- Lead Sponsor
- Academisch Medisch Centrum (AMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Male and Female patients, aged between 18-60 years;
2. Participants have a current DSM-IV diagnosis of alcohol dependence;
Exclusion Criteria
1. Participants with current severe psychiatric disorders (schizophrenia, schizoaffective disorder,bulimia/anorexia, or ADHD requiring medication) besides depression, bipolar disorder and anxiety;
2. Participants with serious medical illnesses (Parkison’s disease, gastric ulcer, duodenal ulcer, cerebrovascular disease, respiratory insufficiency, hepatic or renal insufficiency, and epilepsy);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is abstinence, measured in time to the first relapse.
- Secondary Outcome Measures
Name Time Method Key secondary outcome measures are the total alcohol consumption and the number of heavy drinking days.<br /><br>Other secondary outcome measures are craving, depression, anxiety, side effects and biological markers.