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

Brief summary:
Gabapentin treatment for alcohol dependence

Detailed description:
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.

Arms:
arm 1: 900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. arm 2: 1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks arm 3: placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

Interventions: intervention 1: Gabapentin 900mg intervention 2: behavioral counseling intervention 3: placebo intervention 4: gabapentin 1800mg
Intervention descriptions: intervention 1: 900 mg gabapentin daily for 12 weeks intervention 2: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info. intervention 3: lactose capsule compounded to mimic gabapentin capsules intervention 4: 1800 mg gabapentin daily for 12 weeks

Protocol document: