Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Acamprosate: Genes Associated With Response (ACAM)
This study is not yet open for participant recruitment.
Verified by Mayo Clinic, April 2008
Sponsors and Collaborators: Mayo Clinic
Samuel C. Johnson Foundation
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00662571
  Purpose

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.


Condition Intervention Phase
Alcoholism
 Drug: acamprosate
 Phase IV

MedlinePlus related topics: Alcoholism
Drug Information available for: Acamprosate Acamprosate calcium Ethanol Aspartic acid Glutamic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title: A Pilot Probe Study of Acamprosate: Genes Associated With Response

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental

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.

 Drug: acamprosate
acamprosate 333mg tabs, 2tabs 3times per day = 1998mg/day

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or females, Age 18-65.
  2. 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.
  8. Diagnosis of active substance dependence other than alcohol (i.e.: cannabis, caffeine, prescription use of barbiturates, benzodiazepines, opiates, or stimulants) according to DSM-IV-TR criteria as determined by the PRISM (nicotine is not exclusionary).
  9. Active suicidal ideation as determined by responses provided during PRISM or as determined by the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662571

Contacts
Contact: David Mrazek, M.D. 507-255-9412 mrazek.david@mayo.edu
Contact: Mark Frye, M.D. 507-255-9412 frye.mark@mayo.edu

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Samuel C. Johnson Foundation
Investigators
Principal Investigator: David Mrazek, M.D. Mayo Clinic, Department of Psychiatry
  More Information

Responsible Party: Mayo Clinic ( David Mrazek, M.D. )
Study ID Numbers: 07-007204, P20-acam
Study First Received: April 14, 2008
Last Updated: April 18, 2008
ClinicalTrials.gov Identifier: NCT00662571  
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
nucleotide polymorphisms
disequilibrium haplotype
acamprosate
differentiate
pharmacogenomic
effective individualized treatment
 alcohol dependent
N-methyl-D-aspartate receptor (NMDA)
metabotropic glutamate receptor
decreasing craving
abstinence maintenance

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
 Alcohol-Related Disorders
N-Methylaspartate
Acamprosate
Ethanol

Additional relevant MeSH terms:
Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services