Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

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

Study Overview

• Status: Terminated
• Conditions: Alcoholism; Alcohol Abuse
• Intervention / Treatment: Drug: Placebo; Drug: Ondansetron; Behavioral: BASICS Plus

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Clinical Neurobehavioral Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ondansetron; Ondansetron + BASICS Plus	Drug: Ondansetron; Ondansetron (4ug/kg bid),; Other Names: Zofran; Behavioral: BASICS Plus; Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.
Placebo Comparator: Placebo; Placebo + BASICS Plus	Drug: Placebo; Placebo bid; Other Names: Sugar pill; Behavioral: BASICS Plus; Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Bankole Johnson, DSc,MD,PhD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimated): April 29, 2009

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: binge drinking; alcohol abuse; heavy drinking; alcoholism; severe drinking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Ondansetron
• Other Study ID Numbers: HP-00063000; 2R01AA010522-13 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A IPD sharing plan has not been developed.