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Anti-emetic

Ondansetron for Alcoholism

Phase 2
Waitlist Available
Led By Bankole Johnson, DSc, MD, PhD
Research Sponsored by Bankole Johnson
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 throughout the study
Awards & highlights

Summary

The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Secondary study objectives
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: TopiramateExperimental Treatment1 Intervention
Topiramate + cognitive behavioral therapy
Group II: Ondansetron + TopiramateExperimental Treatment1 Intervention
Ondansetron + Topiramate + cognitive behavioral therapy
Group III: OndansetronExperimental Treatment1 Intervention
Ondansetron + cognitive behavioral therapy
Group IV: PlaceboPlacebo Group1 Intervention
Placebo + cognitive behavioral therapy

Find a Location

Who is running the clinical trial?

Bankole JohnsonLead Sponsor
8 Previous Clinical Trials
1,001 Total Patients Enrolled
6 Trials studying Alcoholism
796 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
823 Previous Clinical Trials
1,160,986 Total Patients Enrolled
432 Trials studying Alcoholism
778,147 Patients Enrolled for Alcoholism
Bankole Johnson, DSc, MD, PhDPrincipal InvestigatorUniversity of Virginia
3 Previous Clinical Trials
220 Total Patients Enrolled
3 Trials studying Alcoholism
220 Patients Enrolled for Alcoholism
~16 spots leftby Sep 2025
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