CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 293 enrolled
Drug / intervention
Ondansetron +1 moredrug
Likely dose
Ondansetron 0.33 mgfrom 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/NCT02354703
NCT02354703Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder

University of Maryland, Baltimore·interventional·Posted Feb 3, 2015·Updated Jan 14, 2022

In Brief

A Phase 2 clinical trial evaluating Ondansetron and Placebo for Alcohol Use Disorder. Completed, enrolled 293 participants across 3 sites.

Detailed Summary

The primary study objective is to determine the efficacy of ondansetron (0.33 mg twice daily) administered orally for a period of 16 weeks in reducing risky drinking among currently drinking subjects with alcohol use disorder who have selected genotypes at the serotonin transporter and receptor genes. The secondary objective is to assess the safety and tolerability of ondansetron in subjects with alcohol use disorder who have selected genotypes at the serotonin transporter and receptor genes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
CollaboratorsUniversity of Pennsylvania

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 3, 2015
Enrollment StartAug 1, 2015
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.4 years ago

Interventions

Ondansetrondrug

Ondansetron (0.33 mg) bid+ BBCET counseling

Placebodrug

Placebo + BBCET counseling