Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults - Full Text View

Sponsor:	Bankole Johnson
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):	Bankole Johnson, University of Virginia
ClinicalTrials.gov Identifier:	NCT00890149

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 II

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:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

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:	June 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

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

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, District of Columbia
Carl Vogel Center	Not yet recruiting
Washington, District of Columbia, United States, 20005
Contact: Katelyn Hobbs 434-924-9416 kkh4q@hscmail.mcc.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
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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Bankole Johnson, DSc,MD,PhD

University of Virginia

More Information

Additional Information:

UVA CARE Website This link exits the ClinicalTrials.gov site

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:	February 3, 2012
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 February 09, 2012