CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 288 enrolled
Drug / intervention
Acamprosate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03818191
NCT03818191Phase 4Completed

Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

Mayo Clinic·interventional·Posted Jan 28, 2019·Updated Dec 17, 2024

In Brief

A Phase 4 clinical trial evaluating Acamprosate and Placebo for Alcohol Use Disorder. Completed, enrolled 288 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 28, 2019
Enrollment StartJul 15, 2019
Primary CompletionNov 4, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.4 years ago

Interventions

Acamprosatedrug

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

Placeboother

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