Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Alcoholism Clinical Trial

Official title:

Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00890149
• Other study ID #: HP-00063000
• Secondary ID: 2R01AA010522-13
• Status: Terminated
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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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Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Intervention

Drug:
• Ondansetron
Ondansetron (4ug/kg bid),
• Placebo
Placebo bid

Behavioral:
• BASICS Plus
Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.

Locations

Country	Name	City	State
United States	Clinical Neurobehavioral Center	Columbia	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping	Throughout the study
Secondary	Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change	ICR Scale to abstain from using alcohol, ICR Scale for medication adherence, medication compliance,craving assessments	Throughout the study