Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
Information source: University of Virginia
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Abuse; Alcoholism
Intervention: Ondansetron + BASICS Plus (Drug); Placebo + BASICS Plus (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Bankole Johnson Official(s) and/or principal investigator(s):
Bankole Johnson, DSc,MD,PhD, Principal Investigator, Affiliation: University of Virginia
Overall contact:
Mindy Borszich, Phone: 1-888-882-2345, Email: mcb3x@virginia.edu
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
Clinical Details
Official title: Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 25 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mindy Borszich, Phone: 1-888-882-2345, Email: mcb3x@virginia.edu
Carl Vogel Center, Washington, District of Columbia 20005, United States; Not yet recruiting
Katelyn Hobbs, Phone: 434-924-9416, Email: kkh4q@hscmail.mcc.virginia.edu
Eva Jenkins-Mendoza, Phone: (434)243-0562, Email: emj9c@virginia.edu
Bankole Johnson, DSc, MD, PhD, Principal Investigator
Nassima Ait-Daoud Tiouririne, MD, Sub-Investigator
University of Virginia Center for Addiction Research and Education, Charlottesville, Virginia 22911, United States; Recruiting
Mindy Borszich, Phone: 888-882-2345, Email: mcb3x@virginia.edu
Eva Jenkins-Mendoza, Phone: (434)243-0562, Email: emj9c@virginia.edu
Bankole Johnson, DSc, MD, PhD, Principal Investigator
Nassima Ait-Daoud Tiouririne, M.D., Sub-Investigator
UVA CARE Richmond, Richmond, Virginia 23294, United States; Recruiting
Mindy Borszich, Phone: 888-882-2345, Email: mcb3x@virginia.edu
Eva Jenkins-Mendoza, Phone: (434)243-0562, Email: emj9c@virginia.edu
Bankole Johnson, DSc, MD, PhD, Principal Investigator
Nassima Ait-Daoud Tiouririne, MD, Sub-Investigator
Additional Information
UVA CARE Website
Starting date: January 2009
Last updated: February 3, 2012
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