Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330174
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2006-05-25
Brief Title:
Acamprosate in Alcoholics With Comorbid Anxiety or Depression
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
The Use of Acamprosate in Individuals With Alcohol Dependence and Comorbid Anxiety or Depression
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 andor 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
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 andor 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 andor 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
Detailed Description:
Participants who meet all inclusion criteria and none of the exclusion criteria will be randomized to receive either acamprosate or placebo in a 11 ratio Participants will be instructed to take 2 333 mg tablets three times a day Participants will be seen weekly for 12 weeks an again 14 weeks from randomization At each weekly visit participants will be asked about substance use and possible adverse events They will also have their vital signs and weight measured at each visit Psychiatric assessments including the MADRSHAM-A Liebowitz Social Anxiety Scale and Hospital Anxiety and Depression Scale will be performed at weeks 2 4 8 and 12 Alcohol craving will be assessed using the Obsessive Compulsive Drinking Scale at baseline and monthly A urine drug screen will also be performed monthly A clinical global impressions scale will be completed for both psychiatric and alcohol abuse symptoms at every visit A breath alcohol test will be performed at every visit and a urine drug screen will be performed at baseline and monthly during the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None