Alcohol Dependence
Conditions
Interventions
Product Name: Baclofen
Product Code: Baclofen
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Baclofen
CAS Number: 1134-47-0
Current Sponsor code: Baclofen
Concentration unit: mg milligram(s)
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Alcohol dependence according to ICD-10 and DSM-IV - Age 18 to =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of baclofen in alcohol dependence. 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: - Safety and tolerability - Drop-out rate - 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 | — |
Countries
Germany
Outcome results
None listed