Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

Alcohol Use Disorder Clinical Trial

Official title:

Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818191
• Other study ID #: 18-006428
• Secondary ID: 1R01AA027486-011
• Status: Completed
• Phase: Phase 4
• Start date: July 15, 2019
• Est. completion date: November 4, 2023

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: November 4, 2023
• Est. primary completion date: November 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age 18 to85; DSM-5 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 35 days);

3. Ability to provide informed consent

4. Ability to speak English

5. Willingness to use the study medications for 3 months and attend follow-up visits.

6. 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).

7. Willingness to discontinue previously prescribed acamprosate for a period of at least 3 days before randomization to study medication (acamprosate or placebo).

Exclusion Criteria:

1. Hypersensitivity or allergy to acamprosate

2. Current use of wellbutrin and not willing to switch to an acceptable antidepressant medication

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 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

7. 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.

8. Current use of Naltrexone and not willing to stop and switch to Acamprosate/Placebo

9. Current use of Antabuse.

10. Active suicidal ideation or any unstable medical or psychiatric condition as determined by responses to PRISM or by the investigator.

11. Status of involuntary or court-ordered admission at time of consent.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

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

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

Locations

Country	Name	City	State
United States	Hazelden Betty Ford Foundation	Center City	Minnesota
United States	Hazelden Betty Ford Foundation	Newberg	Oregon
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Timeline Follow Back	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.	will be defined as continuous sobriety (yes/no) during 3 months of treatment
Secondary	Alcohol Timeline Follow Back	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.	The number of days until first alcohol use assessed by TLFB during 3 months of treatment

External Links

•   Mayo Clinic Clinical Trials