NCT00929344

Duloxetine Versus Pregabalin for Alcohol Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The Scripps Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Pregabalin	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.
DRUG	Duloxetine	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.
BEHAVIORAL	Standardized behavioral therapy	Standardized behavioral therapy 1 time per week for 12 week duration.
BEHAVIORAL	Standardized behavioral therapy	Standardized behavioral therapy 1 time per week for 12 week duration.
DRUG	Placebo	Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
BEHAVIORAL	Standardized behavioral therapy	Standardized behavioral therapy 1 time per week for 12 week duration.

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2009-06-29
• Last updated: 2017-05-04
• Results posted: 2017-03-28

Locations

1 site across 1 country: United States