Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of Maryland
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bankole A. Johnson, University of Maryland
ClinicalTrials.gov Identifier:
NCT00890149
First received: April 27, 2009
Last updated: August 26, 2014
Last verified: August 2014
  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 Maryland:

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: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (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: Maria Johnson, D.M.D. 6672142003 mjohnson@psych.umaryland.edu
Contact: Nanci Henningsen 4103286803 nhenning@psych.umaryland.edu

Locations
United States, Maryland
Clinical Neurobehavioral Center Not yet recruiting
Ellicot City, Maryland, United States, 21043
Contact: Maria Johnson, D.M.D.    410-328-6738    mjohnson2@peds.umaryland.edu   
Contact: Nanci Henningsen    410-328-6803    nhenning@psych.umaryland.edu   
Principal Investigator: Bankole Johnson, DSc, MD, PhD         
Sponsors and Collaborators
Bankole A. Johnson
Investigators
Principal Investigator: Bankole Johnson, DSc,MD,PhD University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Bankole A. Johnson, Chair of Department Psychiatry, University of Maryland
ClinicalTrials.gov Identifier: NCT00890149     History of Changes
Other Study ID Numbers: 13610, 2R01AA010522-13
Study First Received: April 27, 2009
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced 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 September 22, 2014