Alcohol Dependence
Conditions
Brief 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.
Interventions
DRUGBaclofen
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.
DRUGPlacebo
Placebo
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total abstinence from alcohol and cumulative abstinence duration | 13-16 weeks (depending on the individually tolerated baclofen dose) |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events | 24 weeks |
Countries
Germany
Outcome results
None listed