Status:
COMPLETED
Acamprosate: Genes Associated With Response
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Samuel C. Johnson Foundation
Conditions:
Alcoholism
Eligibility:
All Genders
18-80 years
Brief Summary
In 2004, acamprosate was approved in the U.S. for abstinence maintenance, by decreasing craving, in alcoholic patients who have undergone detoxification. while a new anti-craving drug was encouraging,...
Detailed Description
The primary objective of this pharmacogenomic probe study of acamprosate is to identify genetic variations that predict response. Our hypothesis is that effective acamprosate response in alcohol depen...
Eligibility Criteria
Inclusion
- Male or females, Age 18-80.
- 2\. Primary diagnosis of alcohol dependence based on DSM-IV-TR criteria and determined by the Psychiatric Research Interview for Substance and Mental Disorders (PRISM) (stable mood and anxiety disorders will not be exclusionary).
- Prior enrollment in the IRB approved protocol "Developing a DNA Repository for Genomic Studies of Addiction: A Pilot Study".
Exclusion
- Inability to provide informed consent.
- Inability to speak English.
- History of hypersensitivity or allergic reaction to acamprosate.
- Moderate to severe renal impairment, as determined by a creatinine level \> 1.5 mg/dL.
- Diagnosis of primary biliary cirrhosis, chronic active hepatitis, and drug-induced hepatic insufficiency, as noted in the medical record.
- Women who are pregnant, lactating, or are planning to become pregnant during the next year.
- Any unstable active medical or additional psychiatric condition as determined by the investigator.
- 9\. Active suicidal ideation as determined by responses provided during PRISM or as determined by the investigator.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT00662571
Start Date
May 1 2008
End Date
February 1 2013
Last Update
March 22 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905