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Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

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ClinicalTrials.gov Identifier: NCT03818191
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Victor M. Karpyak, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Acamprosate Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
Estimated Study Start Date : July 5, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Acamprosate

All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial.

The most common side effect associated with acamprosate use is diarrhea, which occurs in approximately 16% of patients. Other frequently occurring side effects include asthenia, nausea, pruritus, and flatulence, headache, abdominal pain, flu syndrome, edema, weight gain, and myalgia.

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

Placebo Comparator: Placebo
All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial.
Other: Placebo
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Alcohol Timeline Follow Back [ Time Frame: The number of days until first alcohol use 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 70; DSM-5 (14) diagnosis of AUD determined by PRISM;
  2. Completion of alcohol detoxification (CIWA score < 5) and no alcohol for at least 7 days (but no more than 21 days);
  3. Ability to provide informed consent; and
  4. Willingness to use the study medications for 3 months and attend follow-up visits.

Exclusion Criteria:

  1. Hypersensitivity or allergy to acamprosate or escitalopram;
  2. Refusal to switch to or initiate escitalopram for treatment of anxiety or depressive disorders;
  3. Renal impairment (creatinine level >1.5 mg/dL);
  4. Diagnosis of advanced liver disease indicated in the medical record or by a MELD score of above 10;
  5. Women who are pregnant, breastfeeding, or planning to become pregnant during the next year;
  6. Primary diagnosis of substance use disorder other than alcohol as determined by PRISM;
  7. Current use of benzodiazepines, opioids or any other addictive medications
  8. Active suicidal ideation or any unstable medical or psychiatric condition as determined by responses to PRISM or by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818191


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Victor M Karpyak Mayo Clinic

Additional Information:
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Responsible Party: Victor M. Karpyak, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03818191     History of Changes
Other Study ID Numbers: 18-006428
1R01AA027486-01 ( U.S. NIH Grant/Contract )
1U01AA027487 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acamprosate
Alcohol Deterrents