Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

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.

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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