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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 14, 2008 | ||||||||
| Last Updated Date | October 13, 2009 | ||||||||
| Start Date ICMJE | May 2008 | ||||||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00662571 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Acamprosate: Genes Associated With Response | ||||||||
| Official Title ICMJE | A Pilot Probe Study of Acamprosate: Genes Associated With Response | ||||||||
| 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, 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. |
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| 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 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Retrospective | ||||||||
| Condition ICMJE | Alcoholism | ||||||||
| Intervention ICMJE | Drug: acamprosate | ||||||||
| Study Arms / Comparison Groups | 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. |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | April 2012 | ||||||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
9. Active suicidal ideation as determined by responses provided during PRISM or as determined by the investigator. |
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00662571 | ||||||||
| Responsible Party | David Mrazek, M.D., Mayo Clinic | ||||||||
| Study ID Numbers ICMJE | 07-007204, P20-acam | ||||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||||
| Collaborators ICMJE | Samuel C. Johnson Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||||||
| Verification Date | October 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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