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NCT00330174 · ClinicalTrials.gov registry record · Phase 4
Acamprosate in Alcoholics With Comorbid Anxiety or Depression
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
NCT00330174 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 90 participants.
The verdict
NCT00330174, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
Study 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.
Interventions
- DRUG Acamprosate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2006-04 |
| Est. Completion | 2010-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00330174
The ClinicalTrials.gov registry entry for NCT00330174 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acamprosate is the first listed.
NCT00330174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00330174 about?
NCT00330174 is a clinical study titled "Acamprosate in Alcoholics With Comorbid Anxiety or Depression". 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 anxiet...
What is the current status of trial NCT00330174?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2006-04. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00330174?
The interventions under investigation include: Acamprosate (DRUG).
Who is sponsoring clinical trial NCT00330174?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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