Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Study Overview
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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

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.

Official Title
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Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Conditions
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Alcohol Abuse, Alcoholism

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Placebo
* Behavioral: BASICS Plus


Participation Criteria
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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 Exclusion Criteria: Please contact site for additional information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br>Ondansetron + BASICS Plus | Drug: Ondansetron<br>* Ondansetron (4ug/kg bid),<br>* Other names: Zofran;Behavioral: BASICS Plus<br>* Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.<br>|
| Placebo Comparator: Placebo<br>Placebo + BASICS Plus | Drug: Placebo<br>* Placebo bid<br>* Other names: Sugar pill;Behavioral: BASICS Plus<br>* Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping | Throughout the study | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol abuse, binge drinking, severe drinking, alcoholism, heavy drinking