Conditions: Alcohol Dependence
Keywords: Alcohol Alcohol treatment Alcoholism Alcohol Abuse Alcohol Dependence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Pregabalin intervention 2: Duloxetine intervention 3: Standardized behavioral therapy intervention 4: Standardized behavioral therapy intervention 5: Placebo intervention 6: Standardized behavioral therapy
Intervention descriptions: intervention 1: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. intervention 2: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. intervention 3: Standardized behavioral therapy 1 time per week for 12 week duration. intervention 4: Standardized behavioral therapy 1 time per week for 12 week duration. intervention 5: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. intervention 6: Standardized behavioral therapy 1 time per week for 12 week duration.

Protocol document: