Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
Information source: University of Virginia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Abuse
Intervention: Ondansetron (Drug); Sugar Pill (Other); BASICS Plus (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Virginia 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: uvacare@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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study
Primary outcome: Reduction in alcohol use
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:
- Males and females who have given written informed consent.
- Between the ages of 18 and 25 years Also, patients must weigh ≥40 kg and ≤155 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 one episode of binge or heavy drinking on one day of the week, for each of
the 4 weeks prior to enrollment. For men and women, that is ≥5 and ≥4 drinks/drinking
day, respectively.
- Negative urine drug screen at enrollment.
- 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:
- Any current axis I DSM-IV psychiatric disorder other than nicotine dependence.
- Elevation of liver enzymes—serum glutamic oxaloacetic transaminase (SGOT), serum
glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate
dehydrogenase (LDH).
- Severe alcohol withdrawal symptoms that, in the physician's opinion, require
inpatient treatment.
- Serious medical comorbidity requiring medical intervention or close supervision, or
any condition that can interfere with the receipt of ondansetron.
- Females who are pregnant, lactating, or not adhering to an acceptable form of
contraception at any time during the study.
- Received inpatient or outpatient treatment for alcohol dependence within the last 30
days.
- Compelled to participate in an alcohol treatment program to maintain their liberty.
- Members of the same household.
- Current treatment (previous month) with any medications having a potential effect on
alcohol consumption and related behaviors or mood.
Locations and Contacts
Mindy Borszich, Phone: 1-888-882-2345, Email: uvacare@virginia.edu
UVA CARE, Charlottesville, Virginia 22911, United States; Recruiting
UVA CARE Richmond, Richmond, Virginia 23294, United States; Recruiting
Additional Information
Starting date: January 2009
Ending date: June 2014
Last updated: April 29, 2009
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