Duloxetine Versus Pregabalin for Alcohol Dependence

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

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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• The Scripps Research Institute

  lead OTHER

Principal Investigators

• Barbara J Mason, Ph.D. · The Scripps Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• United States

Study Locations