Acamprosate in Alcoholics With Comorbid Anxiety or Depression

Summary

STUDY OBJECTIVES:

The primary objective of this study is to compare the safety and efficacy of acamprosate versus placebo in the treatment of alcohol dependence in adults with co-occurring mood or anxiety disorders (specifically, depression (MDE), generalized anxiety disorder (GAD) or social anxiety disorder). Secondary objectives are to evaluate the effect of acamprosate treatment on mood and anxiety disorders.

STUDY DESIGN:

This is a randomized, double-blind, placebo-controlled trial evaluating acamprosate in the treatment of alcohol dependence in adult outpatients with concurrent mood and/or anxiety disorders. The active study phase will be 12 weeks in duration. There will be a two-week screening period, followed by 12 weeks of study medication and a follow-up assessment at 14 weeks from randomization.

STUDY POPULATION:

A total of 90 (30 per site) men and women aged 18-60 years who have a current diagnosis of alcohol dependence as well as a current DSM-IV diagnosis of either MDE, GAD and/or social anxiety will be recruited to participate in this study. Only those individuals whose psychiatric disorders are stable will be randomized to acamprosate or placebo. Three sites will participate in this trial.

TREATMENTS:

Eligible participants will be randomly assigned to receive either acamprosate or matching placebo for 12 weeks.

EFFICACY ASSESSEMENTS:

The primary efficacy outcome measure will be cumulative days abstinent as measured by self-report.

Conditions

• Alcohol Dependence
• Major Depression
• Social Anxiety Disorder
• Generalized Anxiety Disorder

Interventions

DRUG

Acamprosate

2 333mg tablets three times daily

Sponsors & Collaborators

• Mclean Hospital

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Susan C Sonne, PharmD, BCPP · Medical University of South Carolina

• Jennifer S Potter, PhD · Mclean Hospital

• Richard Rosenthal, MD · Columbia University College of Physicians & Surgeons

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-04-30

Primary Completion

2010-09-30

Completion

2010-09-30

Countries

• United States

Study Locations