Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03818191
The ClinicalTrials.gov registry entry for NCT03818191 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03818191 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.