Acamprosate in Alcoholics With Comorbid Anxiety or Depression
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.
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.
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.
Eligible participants will be randomly assigned to receive either acamprosate or matching placebo for 12 weeks.
The primary efficacy outcome measure will be cumulative days abstinent as measured by self-report.
Social Anxiety Disorder
Generalized Anxiety Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Use of Acamprosate in Individuals With Alcohol Dependence and Comorbid Anxiety or Depression|
- Percent Days Drinking [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]This 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.
- Liebowitz Social Anxiety Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.
- Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]This is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.
|Study Start Date:||April 2006|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
2 333mg tablets three times daily
Placebo Comparator: 2
Matching placebo tablets
2 333mg tablets three times daily
Participants who meet all inclusion criteria and none of the exclusion criteria will be randomized to receive either acamprosate or placebo in a 1:1 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 MADRS,HAM-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330174
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|United States, New York|
|Columbia University College of Physicians & Surgeons|
|New York, New York, United States, 10025|
|United States, South Carolina|
|Behavioral Health Services of Pickens County|
|Pickens, South Carolina, United States, 29671|
|Principal Investigator:||Susan C Sonne, PharmD, BCPP||Medical University of South Carolina|
|Principal Investigator:||Jennifer S Potter, PhD||Mclean Hospital|
|Principal Investigator:||Richard Rosenthal, MD||Columbia University College of Physicians & Surgeons|