Due to economic pressures, health care delivery is being restructured in the United States. Consequently, the treatment of the alcohol withdrawal syndrome (AWS) is now occurring more frequently in outpatient settings. Benzodiazepines (BZS) have been the primary medication treatment for AWS in North American for 30 years. However, a growing number of preclinical and clinical studies suggest that the anticonvulsant carbamazepine (CBZ) is equal in overall efficacy to BZS for the treatment of AWS. Further, there are several reasons to believe that CBZ may be superior to BZS for the treatment of AWS in outpatients, including the fact that CBZ has little abuse potential and the drug does not interact with alcohol to enhance CNS depression. Moreover, given its purported """"""""anti-kindling"""""""" properties, CBZ may be more efficacious for the treatment of AWS is patients who have had a history of multiple previous detoxifications and, therefore, may be more likely to present with more serious alcohol withdrawal symptoms. The present study represents a double-blind, placebo controlled clinical trial comparing the efficacy of the BZ lorazepam, to CBZ in outpatient alcoholics who meet DSM-IV criteria for a diagnosis of uncomplicated AWS. The two medication groups will be stratified on the basis of past history of detoxifications, and will be balanced for potentially important baseline characteristics. Subjects enrolled in the study will receive medications for 5 consecutive days in a """"""""fixed dose taper"""""""" method. The will return for follow-up evaluation one week later. The primary dependent variable, severity of AWS, will be determined by the CIWA-Ar. Other dependent variables (e.g., side effect checklist, visual analog scales, cognitive assessments) will be assessed for secondary analyses, as well.
The aim of this project is to provide relevant clinical information for primary care practitioners who will be treating AWS in ambulatory outpatient settings. Additionally, information will be obtained which will enhance our scientific knowledge regarding the effects of alcohol withdrawal-induced neuronal sensitization and the efficacy of the two classes of medications for the treatment of AWS.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Specialized Center (P50)
Project #
5P50AA010761-02
Application #
6233897
Study Section
Project Start
1996-12-01
Project End
1997-11-30
Budget Start
1996-10-01
Budget End
1997-09-30
Support Year
2
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Medical University of South Carolina
Department
Type
DUNS #
183710748
City
Charleston
State
SC
Country
United States
Zip Code
29425
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