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Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00890149
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : August 21, 2017
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Alcohol Abuse Alcoholism Drug: Ondansetron + BASICS Plus Drug: Placebo + BASICS Plus Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
Actual Study Start Date : September 2015
Primary Completion Date : September 2016
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ondansetron
Ondansetron + BASICS Plus
Drug: Ondansetron + BASICS Plus
Ondansetron (4ug/kg bid), Brief Alcohol Screening and Intervention for College Students
Other Name: Zofran
Placebo Comparator: Placebo
Placebo + BASICS Plus
Drug: Placebo + BASICS Plus
Placebo bid, Brief Alcohol Screening and Intervention for College Students
Other Name: Sugar pill

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: Throughout the study ]
    Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping

Secondary Outcome Measures :
  1. Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change [ Time Frame: Throughout the study ]
    ICR Scale to abstain from using alcohol, ICR Scale for medication adherence, medication compliance,craving assessments

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890149

United States, Maryland
Clinical Neurobehavioral Center
Columbia, Maryland, United States, 21045
Sponsors and Collaborators
Bankole A. Johnson
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Bankole Johnson, DSc,MD,PhD University of Maryland
More Information

Responsible Party: Bankole A. Johnson, Chair of Department Psychiatry, University of Maryland
ClinicalTrials.gov Identifier: NCT00890149     History of Changes
Other Study ID Numbers: HP-00063000
2R01AA010522-13 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Bankole A. Johnson, University of Maryland:
alcohol abuse
binge drinking
severe drinking
heavy drinking

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents