Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

Overview

About this study

The purpose of this study is to identify genetic and metabolomic biomarkers associated with acamprosate response in previously collected samples.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:  

  • Age 18 to 85 years old.
  • DSM-5 (14) diagnosis of AUD determined by PRISM.
  • Completion of alcohol detoxification (CIWA score < 5) and no alcohol for at least 7 days (but no more than 28 days).
  • Ability to provide informed consent.
  • Ability to speak English.
  • Willingness to use the study medications for 3 months and attend follow-up visits.
  • No chronic/daily use of benzodiazepines, opioids, or stimulants for a period of time determined by duration of the medication half-life before the initiation of study medication (acamprosate or placebo).
  • Willingness to discontinue previously prescribed acamprosate for a period of up to 3 days before randomization to study medication (acamprosate or placebo).

Exclusion Criteria: 

  • Hypersensitivity or allergy to Acamprosate or Escitalopram.
  • Refusal to switch to Escitalopram for treatment of anxiety or depressive disorders.
  • Renal impairment (creatinine level > 1.5 mg/dL).
  • Diagnosis of advanced liver disease indicated in the medical record or by a MELD score of above 10.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the next year.
  • Primary diagnosis of substance use disorder other than alcohol as determined by PRISM or in medical record review or secondary diagnosis of active (within the past year) benzo/sedative dependence, opioid dependence, stimulant dependence, heroin dependence, and/or cocaine dependence.
  • Refusal to abstain from any chronic/daily use of prescribed benzodiazepines, opioids, stimulants, cannabis related medication such as CBD or medical marijuana, during the course of participation.
  • Current use of Naltrexone or not willing to stop and switch to Acamprosate/Placebo.
  • Current use of Antabuse.
  • Active suicidal ideation or any unstable medical or psychiatric condition as determined by responses to PRISM or by the investigator.
  • Status of involuntary or court-ordered admission at time of consent.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Victor Karpyak, M.D., Ph.D.

Open for enrollment

Contact information:

Autumn Timm

(507)293-3876

Timm.Autumn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20467294

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