Acamprosate Treatment Outcome

Overview

Información sobre este estudio

The purpose of this project is to identify biomarkers by discovery of genomic and metabolomic markers associated with response to acamprosate treatment. To achieve this we will use “pharmacometabolomics-informed pharmacogenomics” such as generation a panel of iPSCs (stem cells) to discover biomarkers.  A new prospective randomized placebo-controlled trial of 3 month long treatment with acamprosate/placebo will provide new biospecimens, in addition to previously collected biospecimens, to enable the search for genetic and metabolomic biomarkers associated with sobriety or relapse in participants of this new study.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

Autumn Timm

(507)293-3876

Timm.Autumn@mayo.edu

Albert Lea, Minn.

Investigador principal de Mayo Clinic

Tyler Oesterle, M.D., M.P.H.

Cerrado para la inscripción

Contact information:

Monica Walton CCRP

(507) 422-0689

Walton.Monica@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20467294

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