Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-03-31

Brief Summary

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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

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Detailed Description

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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

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Alcohol Abuse Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ondansetron

Ondansetron + BASICS Plus

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

Ondansetron (4ug/kg bid),

BASICS Plus

Intervention Type BEHAVIORAL

Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.

Placebo

Placebo + BASICS Plus

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo bid

BASICS Plus

Intervention Type BEHAVIORAL

Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.

Interventions

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Ondansetron

Ondansetron (4ug/kg bid),

Intervention Type DRUG

Placebo

Placebo bid

Intervention Type DRUG

BASICS Plus

Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.

Intervention Type BEHAVIORAL

Other Intervention Names

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Zofran Sugar pill

Eligibility Criteria

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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