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AlcoholismACAMNCT00662571

Acamprosate: Genes Associated With Response

An observational study of Alcoholism, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Alcoholism
What is being tested?
acamprosate
How many people
485 participants
Where
1 siteUnited States
Study dates
May 2008to Feb 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects selected from Mayo Clinics Addiction programs.

Who may be able to join

  • 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".

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A 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.

Read the 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.

Conditions
Alcoholism
Being tested
acamprosate
Keywords
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
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acamprosateDrug

    Also called Campral is the brand name of acamprosate.

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

Study groups in NCT00662571
Study groupRoleWhat they receive
AOur 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.
Receives: Drug: acamprosate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aim 1: To determine the relationship between genetically determined variation in the NMDA receptor and treatment response to acamprosate.

    Measured: 6 months

Secondary outcomes (1)

  1. Aim 2: To determine the relationship between genetically determined variation in the mGluR5 receptor and treatment response to acamprosate.

    Measured: 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00662571
Sponsor's protocol ID
07-007204
Other IDs
P20-acam
Acronym
ACAM
Status last verified
Mar 2013
First submitted
14 Apr 2008
Last updated
22 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Ho MF, Zhang C, Cohan JS, Tuncturk M, Heider RM, Coombes BJ, Biernacka J, Moon I, Skime M, Ho AM, Ngo Q, Skillon C, Croarkin PE, Oesterle TS, Karpyak VM, Li H, Weinshilboum RM. IL17RB genetic variants are associated with acamprosate treatment response in patients with alcohol use disorder: A proteomics-informed genomics study. Brain Behav Immun. 2024 Aug;120:304-314. doi: 10.1016/j.bbi.2024.06.007. Epub 2024 Jun 8.

    PubMed 38852760

  • Ho MF, Zhang C, Moon I, Biernacka J, Coombes B, Ngo Q, Skillon C, Skime M, Oesterle T, Croarkin PE, Karpyak VM, Li H, Weinshilboum RM. Epigenetic regulation of GABA catabolism in iPSC-derived neurons: The molecular links between FGF21 and histone methylation. Mol Metab. 2023 Nov;77:101798. doi: 10.1016/j.molmet.2023.101798. Epub 2023 Sep 7.

    PubMed 37689244

  • Karpyak VM, Coombes BJ, Geske JR, Pazdernik VM, Schneekloth T, Kolla BP, Oesterle T, Loukianova LL, Skime MK, Ho AM, Ngo Q, Skillon C, Ho MF, Weinshilboum R, Biernacka JM. Genetic predisposition to major depressive disorder differentially impacts alcohol consumption and high-risk drinking situations in men and women with alcohol use disorder. Drug Alcohol Depend. 2023 Feb 1;243:109753. doi: 10.1016/j.drugalcdep.2022.109753. Epub 2022 Dec 24.

    PubMed 36608483

  • Ho MF, Zhang C, Moon I, Wei L, Coombes B, Biernacka J, Skime M, Choi DS, Frye M, Schmidt K, Gliske K, Braughton J, Ngo Q, Skillon C, Seppala M, Oesterle T, Karpyak V, Li H, Weinshilboum R. Genome-wide association study for circulating FGF21 in patients with alcohol use disorder: Molecular links between the SNHG16 locus and catecholamine metabolism. Mol Metab. 2022 Sep;63:101534. doi: 10.1016/j.molmet.2022.101534. Epub 2022 Jun 22.

    PubMed 35752286

  • Karpyak VM, Biernacka JM, Geske JR, Abulseoud OA, Brunner MD, Chauhan M, Hall-Flavin DK, Lewis KA, Loukianova LL, Melnyk GJ, Onsrud DA, Proctor BD, Schneekloth TD, Skime MK, Wittkopp JE, Frye MA, Mrazek DA. Gender-specific effects of comorbid depression and anxiety on the propensity to drink in negative emotional states. Addiction. 2016 Aug;111(8):1366-75. doi: 10.1111/add.13386. Epub 2016 May 5.

    PubMed 27009547

Questions about this trial

What is this clinical trial studying?

An observational study of Alcoholism, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00662571, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.

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