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Acamprosate to Reduce Symptoms of Alcohol Withdrawal
This study has been completed.
Study NCT00106106   Information provided by National Institutes of Health Clinical Center (CC)

First Received on March 19, 2005.   Last Updated on January 10, 2012   History of Changes
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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.

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
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1.  Primary:   Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 4   [ Time Frame: Day 4 ]
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2.  Primary:   Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 25   [ Time Frame: Day 25 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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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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:
Daeppen JB, Gache P, Landry U, Sekera E, Schweizer V, Gloor S, Yersin B. Symptom-triggered vs fixed-schedule doses of benzodiazepine for alcohol withdrawal: a randomized treatment trial. Arch Intern Med. 2002 May 27;162(10):1117-21.
Liskow BI, Goodwin DW. Pharmacological treatment of alcohol intoxication, withdrawal and dependence: a critical review. J Stud Alcohol. 1987 Jul;48(4):356-70. Review.
Mayo-Smith MF. Pharmacological management of alcohol withdrawal. A meta-analysis and evidence-based practice guideline. American Society of Addiction Medicine Working Group on Pharmacological Management of Alcohol Withdrawal. JAMA. 1997 Jul 9;278(2):144-51.

Publications automatically indexed to this study:
Umhau JC, Momenan R, Schwandt ML, Singley E, Lifshitz M, Doty L, Adams LJ, Vengeliene V, Spanagel R, Zhang Y, Shen J, George DT, Hommer D, Heilig M. Effect of acamprosate on magnetic resonance spectroscopy measures of central glutamate in detoxified alcohol-dependent individuals: a randomized controlled experimental medicine study. Arch Gen Psychiatry. 2010 Oct;67(10):1069-77.


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





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