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Acamprosate to Reduce Symptoms of Alcohol Withdrawal

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Markus Heilig, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00106106
First received: March 19, 2005
Last updated: January 10, 2012
Last verified: January 2012
Results First Received: November 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Conditions: Alcohol-Related Disorders
Alcohol Dependence
Alcoholism
Healthy Volunteer
Interventions: Procedure: NMR-spectroscopy
Drug: Oral 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
No text entered.

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

Reporting Groups
  Description
Placebo For subjects randomized to placebo control, placebo doses were given every 8 hours.
Acamprosate For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.

Participant Flow:   Overall Study
    Placebo     Acamprosate  
STARTED     26     23  
Completed Both MRS Scans     18     15  
COMPLETED     22 [1]   19 [2]
NOT COMPLETED     4     4  
[1] Although 22 subjects completed all other assessments for the study, only 18 completed both MRS scans
[2] Although 19 subjects completed all other assessments for the study, only 15 completed both MRS scans



  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
  Description
Placebo For subjects randomized to placebo control, placebo doses were given every 8 hours.
Acamprosate For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
Total Total of all reporting groups

Baseline Measures
    Placebo     Acamprosate     Total  
Number of Participants  
[units: participants]
  26     23     49  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     23     49  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  35.1  ± 6.1     35.0  ± 5.8     35.1  ± 6.5  
Gender  
[units: participants]
     
Female     11     8     19  
Male     15     15     30  
Region of Enrollment  
[units: participants]
     
United States     26     23     49  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 4   [ Time Frame: Day 4 ]

2.  Primary:   Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 25   [ Time Frame: Day 25 ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Markus A. Heilig, M.D., Ph.D.
Organization: NIH/National Institute on Alcohol Abuse and Alcoholism
phone: 301-435-9386
e-mail: mheilig@mail.nih.gov


Publications:
Publications automatically indexed to this study:

Responsible Party: Markus Heilig, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00106106     History of Changes
Other Study ID Numbers: 050120, 05-AA-0120
Study First Received: March 19, 2005
Results First Received: November 30, 2011
Last Updated: January 10, 2012
Health Authority: United States: Federal Government