Status:
COMPLETED
Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 n...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2023
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT03818191
Start Date
July 15 2019
End Date
November 4 2023
Last Update
December 17 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hazelden Betty Ford Foundation
Center City, Minnesota, United States, 55012
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
3
Hazelden Betty Ford Foundation
Newberg, Oregon, United States, 97132