Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia
ClinicalTrials.gov Identifier:
NCT00890149
First received: April 27, 2009
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Alcohol Abuse
Alcoholism
Drug: Ondansetron + BASICS Plus
Drug: Placebo + BASICS Plus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping


Secondary Outcome Measures:
  • Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
    ICR Scale to abstain from using alcohol, ICR Scale for medication adherence, medication compliance,craving assessments


Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890149

Contacts
Contact: Mindy Borszich 1-888-882-2345 mcb3x@virginia.edu
Contact: Eva Jenkins-Mendoza (434)243-0562 emj9c@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Addiction Research and Education Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Mindy Borszich    888-882-2345    mcb3x@virginia.edu   
Contact: Eva Jenkins-Mendoza    (434)243-0562    emj9c@virginia.edu   
Principal Investigator: Bankole Johnson, DSc, MD, PhD         
Sub-Investigator: Nassima Ait-Daoud Tiouririne, M.D.         
UVA CARE Richmond Recruiting
Richmond, Virginia, United States, 23294
Contact: Mindy Borszich    888-882-2345    mcb3x@virginia.edu   
Contact: Eva Jenkins-Mendoza    (434)243-0562    emj9c@virginia.edu   
Principal Investigator: Bankole Johnson, DSc, MD, PhD         
Sub-Investigator: Nassima Ait-Daoud Tiouririne, MD         
Sponsors and Collaborators
Bankole Johnson
Investigators
Principal Investigator: Bankole Johnson, DSc,MD,PhD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT00890149     History of Changes
Other Study ID Numbers: 13610, 2R01AA010522-13
Study First Received: April 27, 2009
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
alcohol abuse
binge drinking
severe drinking
alcoholism
heavy drinking

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
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

ClinicalTrials.gov processed this record on July 28, 2014