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Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Information source: University of Maryland
ClinicalTrials.gov processed this data on November 27, 2014
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: Not yet recruiting

Sponsored by: Bankole A. Johnson

Official(s) and/or principal investigator(s):
Bankole Johnson, DSc,MD,PhD, Principal Investigator, Affiliation: University of Maryland, Baltimore County

Overall contact:
Maria Johnson, D.M.D., Phone: 6672142003, Email: mjohnson@psych.umaryland.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

Maria Johnson, D.M.D., Phone: 6672142003, Email: mjohnson@psych.umaryland.edu

Clinical Neurobehavioral Center, Ellicot City, Maryland 21043, United States; Not yet recruiting
Maria Johnson, D.M.D., Phone: 410-328-6738, Email: mjohnson2@peds.umaryland.edu
Nanci Henningsen, Phone: 410-328-6803, Email: nhenning@psych.umaryland.edu
Bankole Johnson, DSc, MD, PhD, Principal Investigator
Additional Information

Starting date: September 2014
Last updated: August 26, 2014

Page last updated: November 27, 2014

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