← Back to Search

Serotonin Antagonist

Ondansetron for Alcoholism

Phase 2 & 3
Waitlist Available
Led By Bankole Johnson, DSc, MD, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24)
Awards & highlights

Study Summary

Heavy drinking can cause serious health, family, and economic problems. Finding treatments that are effective in decreasing heavy drinking among alcohol-dependent individuals is, therefore, an important scientific and health goal. A novel and important strategy to enhance alcoholism treatment efforts uses a personalized medicine approach to optimize treatment effects by selecting the "right" patient therapeutically and potentially with a minimum of adverse events, for a specific medication. This study will extend findings from a randomized double-blind clinical trial of ondansetron, in which the medication was found to reduce drinking among individuals with certain genotypes (i.e., forms of DNA, the material that controls the inheritance of characteristics). The proposed study will address a number of limitations in the prior work, including testing the medication in both European-American and African-American samples.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent heavy drinking days
Secondary outcome measures
Drinks per drinking day
Measures of quality of life
Objective measure of treatment measure and adverse event using RNA
+2 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OndansetronExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,073 Total Patients Enrolled
7 Trials studying Alcoholism
26,616 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,285 Total Patients Enrolled
423 Trials studying Alcoholism
985,708 Patients Enrolled for Alcoholism
Bankole JohnsonLead Sponsor
8 Previous Clinical Trials
1,321 Total Patients Enrolled
6 Trials studying Alcoholism
1,116 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby Apr 2025