Status:
TERMINATED
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Abuse
Alcoholism
Eligibility:
All Genders
18-25 years
Phase:
PHASE2
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...
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 a...
Eligibility Criteria
Inclusion
- 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
- Please contact site for additional information
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00890149
Start Date
September 1 2015
End Date
March 1 2017
Last Update
May 26 2023
Active Locations (1)
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1
Clinical Neurobehavioral Center
Columbia, Maryland, United States, 21045