At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Duloxetine Versus Pregabalin for Alcohol Dependence
In Brief
A Phase 2 clinical trial evaluating Pregabalin, Duloxetine, and 2 other interventions for Alcohol Dependence. Completed, enrolled 150 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
Standardized behavioral therapy 1 time per week for 12 week duration.
Standardized behavioral therapy 1 time per week for 12 week duration.
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy 1 time per week for 12 week duration.