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OpenTrials
Completed

NCT Number: NCT03818191

Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

AUDs are difficult to treat, and relapse rates are high, with an estimated 80% of individuals with AUDs returning to alcohol use after completing addictions treatment. Novel treatment approaches are needed to enhance long term sobriety. The investigator's research team has been investigating the use of acamprosate to prevent relapse to alcohol use. Unfortunately despite being FDA approved and endorsed by the American Psychiatric Association only 10% of patients treated for AUD are prescribed acamprosate or other antidipsotropic medications. The number is higher for patients treated in programs affiliated with Mayo Clinic Addiction Services (approximately 20%) but is way less than expected. The most common reasons behind these low numbers are the understanding that not every patient benefits from the use of specific medication and the lack of biomarkers predictive of response. The purpose of this project is to identify such biomarkers by discovery of genomic and metabolomic markers associated with response to acamprosate treatment.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hazelden Betty Ford Foundation, Center City, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to85; DSM-5 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 35 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 which is determined by 3 x the medication half-life value (see addendum A) to be completed before the initiation of study medication (acamprosate or placebo).
  • Willingness to discontinue previously prescribed acamprosate for a period of at least 3 days before randomization to study medication (acamprosate or placebo).

Exclusion criteria

  • Hypersensitivity or allergy to acamprosate
  • Current use of wellbutrin and not willing to switch to an acceptable antidepressant medication
  • 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 and 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.

Treatment and study plan

acamprosate

Drug

The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.

Placebo

Other

The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.

Primary outcomes

  1. Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back

    Time frame: Will be defined as continuous sobriety (yes/no) during 3 months of treatment

    The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.

Secondary outcomes

  1. Day Until First Alcohol Use (Relapse) - Alcohol Timeline Follow Back

    Time frame: The number of days until first alcohol use (relapse) assessed by TLFB during 3 months of treatment

    The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.

  2. Days Until First Relapse (Heavy Relapse) - Timeline Follow Back

    Time frame: Number of days until first relapse (heavy relapse) between medication start and 3 months follow-up

    The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.

  3. Cumulative Abstinence Duration - Timeline Follow Back

    Time frame: Cumulative abstinence duration proportion: proportion of days over the length of 3 month follow-up during which participants were abstinent from alcohol use, a score range of 0 (drinking continuously) to 100 (maintain complete abstinence) is applied.

    The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2019
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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