Acamprosate: Genes Associated With Response
Completed
Conditions studied: Alcoholism
In brief
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, only 36.1% of the subjects treated with acamprosate remained abstinent for 6 months. Having the ability to identify treatment responsive individuals would have a major impact on the use of acamprosate.
Key facts
- Study ID
- NCT00662571
- Run by
- Mayo Clinic
- People needed
- 485
- Starts
- 2008-05-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2013-03-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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".
You may not qualify if…
- 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.
- Active suicidal ideation as determined by responses provided during PRISM or as determined by the investigator.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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