Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/2/2019 |
| Start Date: | April 1, 2019 |
| End Date: | December 31, 2020 |
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.
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.
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.
We found this trial at
3
sites
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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