NCT00890149

Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Abuse
• Alcoholism

Interventions

Type	Name	Description
DRUG	Ondansetron	Ondansetron (4ug/kg bid),
DRUG	Placebo	Placebo bid
BEHAVIORAL	BASICS Plus	Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2017-03-01
• First posted: 2009-04-29
• Last updated: 2023-05-26

Locations

1 site across 1 country: United States