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Completed Phase 4 Interventional Results available

Acamprosate in Alcoholics With Comorbid Anxiety or Depression

ClinicalTrials.gov ID: NCT00330174

Public ClinicalTrials.gov record NCT00330174. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 7:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Use of Acamprosate in Individuals With Alcohol Dependence and Comorbid Anxiety or Depression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00330174
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
90 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2006
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010
Last update posted
Apr 12, 2015

2006 – 2010

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
McLean Hospital Belmont Massachusetts 02478
Columbia University College of Physicians & Surgeons New York New York 10025
Behavioral Health Services of Pickens County Pickens South Carolina 29671

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00330174, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2015 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00330174 live on ClinicalTrials.gov.

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