Acamprosate in Alcoholics With Comorbid Anxiety or Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00330174
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
Mclean Hospital
Columbia University
Information provided by (Responsible Party):
Susan Sonne, Medical University of South Carolina

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
Major Depression
Social Anxiety Disorder
Generalized Anxiety Disorder
Intervention: Drug: Acamprosate

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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
First Submitted: May 25, 2006
First Posted: May 26, 2006
Results First Submitted: May 29, 2013
Results First Posted: April 13, 2015
Last Update Posted: April 13, 2015