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NCT03818191 · ClinicalTrials.gov registry record · Phase 4
Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 288
- Enrollment target
NCT03818191: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT03818191 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 288 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03818191, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 288 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG Acamprosate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2023-11-04 |
| Phase | Phase 4 |
What the finished NCT03818191 record still lists
NCT03818191 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03818191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03818191 about?
NCT03818191 is a clinical study titled "Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome". 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...
What is the current status of trial NCT03818191?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 288 participants. The study started on 2019-07-15. Estimated completion is 2023-11-04.
What interventions are being tested in trial NCT03818191?
The interventions under investigation include: Placebo (OTHER), Acamprosate (DRUG).
Who is sponsoring clinical trial NCT03818191?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03818191's enrollment target sits among peer trials
288 298th of 2000 higher than 1,700 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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