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Acamprosate: Genes Associated With Response (ACAM)
This study is currently recruiting participants.
Study NCT00662571   Information provided by Mayo Clinic
First Received: April 14, 2008   Last Updated: October 13, 2009   History of Changes

April 14, 2008
October 13, 2009
May 2008
May 2011   (final data collection date for primary outcome measure)
Aim 1: To determine the relationship between genetically determined variation in the NMDA receptor and treatment response to acamprosate. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662571 on ClinicalTrials.gov Archive Site
Aim 2: To determine the relationship between genetically determined variation in the mGluR5 receptor and treatment response to acamprosate. [ Time Frame: 6months ] [ Designated as safety issue: No ]
Same as current
 
Acamprosate: Genes Associated With Response
A Pilot Probe Study of Acamprosate: Genes Associated With Response

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.

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 dependent subjects may be influenced by genetically controlled variation in the functionality of the N-methyl-D-aspartate receptor (NMDA) and/or the type 5 metabotropic glutamate receptor (mGluR5). Hypothesis confirmation could lead to development of effective individualized treatment recommendations for alcohol dependent patients based on pharmacogenomically relevant genetic variations.

The general goal is to identify genetic polymorphic variants that differentiate subjects continuously abstinent for six months while taking acamprosate from relapsed subjects. The initial analysis will determine whether any of ten polymorphisms in four target genes (GRIN1, GRIN2A and GRIN2B that code for the NMDA receptor and GRM5 that codes for the type mGluR5 receptor) are associated with successful abstinence. Subsequent analyses will examine whether variation in a comprehensive set of 383 linkage disequilibrium haplotype tagged single nucleotide polymorphisms of these four genes predicts successfully abstinent subjects.

Phase IV
Observational
Case Control, Retrospective
Alcoholism
Drug: acamprosate

Our hypothesis is that effective acamprosate response in alcohol dependent subjects may be influenced by genetically controlled variation in the functionality of the N-methyl-D-aspartate receptor (NMDA) and/or the type 5 metabotropic glutamate receptor (mGluR5). Hypothesis confirmation could lead to development of effective individualized treatment recommendations for alcohol dependent patients based on pharmacogenomically relevant genetic variations.

There will be no placebo drug given. Just measurement of genetic response.

 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
April 2012
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or females, Age 18-80.
  2. 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).
  3. Prior enrollment in the IRB approved protocol "Developing a DNA Repository for Genomic Studies of Addiction: A Pilot Study".

Exclusion Criteria:

  1. Inability to provide informed consent.
  2. Inability to speak English.
  3. History of hypersensitivity or allergic reaction to acamprosate.
  4. Moderate to severe renal impairment, as determined by a creatinine level > 1.5 mg/dL.
  5. Diagnosis of primary biliary cirrhosis, chronic active hepatitis, and drug-induced hepatic insufficiency, as noted in the medical record.
  6. Women who are pregnant, lactating, or are planning to become pregnant during the next year.
  7. 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.

Both
18 Years to 80 Years
No
Contact: David Mrazek, M.D. 507-255-9412 mrazek.david@mayo.edu
Contact: Mark Frye, M.D. 507-255-9412 frye.mark@mayo.edu
United States
 
NCT00662571
David Mrazek, M.D., Mayo Clinic
07-007204, P20-acam
Mayo Clinic
Samuel C. Johnson Foundation
Principal Investigator: David Mrazek, M.D. Mayo Clinic, Department of Psychiatry
Mayo Clinic
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP