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Acamprosate in Alcoholics With Comorbid Anxiety or Depression

This study has been completed.
Mclean Hospital
Columbia University
Information provided by (Responsible Party):
Susan Sonne, Medical University of South Carolina Identifier:
First received: May 25, 2006
Last updated: April 10, 2015
Last verified: April 2015
Results First Received: May 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
Major Depression
Social Anxiety Disorder
Generalized Anxiety Disorder
Intervention: Drug: Acamprosate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from May 2006 to June 2008. The study was conducted at three sites including a rural community treatment program in South Carolina, an urban community treatment program in New York City, and at an academic setting at McLean Hospital in Belmont, MA

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Acamprosate Acamprosate tablets
Placebo Matching placebo tablets

Participant Flow:   Overall Study
    Acamprosate     Placebo  
STARTED     45     45  
COMPLETED     23     26  
NOT COMPLETED     22     19  
Withdrawal by Subject                 7                 7  
Lost to Follow-up                 4                 1  
Clinical deterioration                 1                 2  
Excessive missed visits                 3                 8  
Miscellaneous reasons                 7                 1  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Acamprosate Acamprosate tablets
Placebo Matching placebo tablets
Total Total of all reporting groups

Baseline Measures
    Acamprosate     Placebo     Total  
Number of Participants  
[units: participants]
  45     45     90  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     45     45     90  
>=65 years     0     0     0  
[units: years]
Mean (Standard Deviation)
  43.6  (9.9)     44.6  (8.7)     44.1  (9.3)  
[units: participants]
Female     16     19     35  
Male     29     26     55  
Region of Enrollment  
[units: participants]
United States     45     45     90  

  Outcome Measures
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1.  Primary:   Percent Days Drinking   [ Time Frame: 12 weeks ]

2.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: 12 weeks ]

3.  Secondary:   Liebowitz Social Anxiety Scale   [ Time Frame: 12 weeks ]

4.  Secondary:   Hospital Anxiety and Depression Scale   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Susan Sonne, PharmD, BCPP
Organization: Medical University of South Carolina
phone: 843.792.5221

Responsible Party: Susan Sonne, Medical University of South Carolina Identifier: NCT00330174     History of Changes
Other Study ID Numbers: CMP-MD-04
Study First Received: May 25, 2006
Results First Received: May 29, 2013
Last Updated: April 10, 2015
Health Authority: United States: Food and Drug Administration