Phase 4
N=288
Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03818191 ↗Enrolled (actual)
288
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back — 66; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acamprosate (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back |
66; 39 | — |
| SECONDARY Day Until First Alcohol Use (Relapse) - Alcohol Timeline Follow Back |
80; 82 | — |
| SECONDARY Days Until First Relapse (Heavy Relapse) - Timeline Follow Back |
81; 82.5 | — |
| SECONDARY Cumulative Abstinence Duration - Timeline Follow Back |
96.57; 96.01 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 to85; DSM-5 diagnosis of AUD determined by PRISM;
- Completion of alcohol detoxification (CIWA score 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.
Data sourced from ClinicalTrials.gov (NCT03818191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.