Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Phase 2

Terminated

• Conditions: Alcohol Abuse; Alcoholism
• Interventions: Drug: Placebo; Drug: Ondansetron; Behavioral: BASICS Plus

• Registration Number: NCT00890149
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Study Timeline

• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-29
• Study Start: 2015-09
• Primary Completion: 2016-09
• Study Completion: 2017-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ondansetron	BASICS Plus	Ondansetron + BASICS Plus
Placebo	Placebo	Placebo + BASICS Plus
Placebo	BASICS Plus	Placebo + BASICS Plus
Ondansetron	Ondansetron	Ondansetron + BASICS Plus

Primary Outcome Measures

Name	Time	Method
Ondansetron + BASICS Plus shall be more effective at reducing severe or binge drinking among emerging adults. The treatment effect of ondansetron on reduction in severe or binge drinking shall be greatest in LL individuals.	Throughout the study	Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping

Secondary Outcome Measures

Name	Time	Method
Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change	Throughout the study	ICR Scale to abstain from using alcohol, ICR Scale for medication adherence, medication compliance,craving assessments

Trial Locations

Locations (1)

Clinical Neurobehavioral Center; 🇺🇸 Columbia, Maryland, United States