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Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

NCT00890149•University of Maryland, Baltimore

Summary

This study will evaluate the efficacy of ondansetron + BASICS Plus in reducing severe or binge drinking among emerging adults. BASIC Plus (Brief Alcohol Screening and Intervention for College Students) has been the most validated brief intervention among college students. The BASICS program provides personal feedback, motivation, and strategies that enhance normative drinking patterns

Detailed Description

We propose to conduct a 9 week study to test the efficacy of ondansetron in a heavy drinking (non-dependent) emerging adult population. We will enroll individuals between the ages of 18 and 25 years as this period overlaps with the general population of those attending college and who can be defined as emerging adults. We will conduct a double-blind control study in which 150 individuals will be randomized into 2 groups, therefore the N will be 300.

Eligibility

Age

18 - 25 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•White Males and females who have given written informed consent.
•Ages 18 through 25;also, patients must weigh ≥40 kg and ≤140 kg.
•Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
•At least an average of one episode of binge or heavy drinking per week in the past month prior to enrollment. For men and women, that is ≥5 and ≥4 drinks/drinking day, respectively.They also need to report at least one day of heavy drinking within the 7 days prior to randomization.
•The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception.
•Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
•Answer an advertisement in the newspaper/radio/television, and express a wish to stop heavy drinking.
•Willingness to participate in behavioral treatments to stop heavy drinking

Exclusion Criteria

•Please contact site for additional information

Locations (1)

Clinical Neurobehavioral Center

Columbia, Maryland, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

September 1, 2016

Completion Date

March 1, 2017

Last Updated

May 26, 2023

Enrollment

ACTUAL participants

Conditions

Alcohol AbuseAlcoholism

Interventions

Ondansetron

DRUG

Placebo

DRUG

BASICS Plus

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Inclusion Criteria

Exclusion Criteria

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