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Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Primary Purpose

Alcohol Abuse, Alcoholism

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ondansetron

Placebo

BASICS Plus

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring alcohol abuse, binge drinking, severe drinking, alcoholism, heavy drinking

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinical Neurobehavioral Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ondansetron

Placebo

Arm Description

Ondansetron + BASICS Plus

Placebo + BASICS Plus

Outcomes

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.

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

ICR Scale to abstain from using alcohol, ICR Scale for medication adherence, medication compliance,craving assessments

Full Information

NCT ID

NCT00890149

First Posted

April 27, 2009

Last Updated

May 24, 2023

Sponsor

University of Maryland, Baltimore

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00890149

Brief Title

Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Official Title

Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Difficulty recruiting target sample

Study Start Date

September 2015 (Actual)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Maryland, Baltimore

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Abuse, Alcoholism

Keywords

alcohol abuse, binge drinking, severe drinking, alcoholism, heavy drinking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ondansetron

Arm Type

Experimental

Arm Description

Ondansetron + BASICS Plus

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo + BASICS Plus

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Other Intervention Name(s)

Zofran

Intervention Description

Ondansetron (4ug/kg bid),

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar pill

Intervention Description

Placebo bid

Intervention Type

Behavioral

Intervention Name(s)

BASICS Plus

Intervention Description

Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.

Primary Outcome Measure Information:

Title

Description

Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping

Time Frame

Throughout the study

Secondary Outcome Measure Information:

Title

Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change

Description

ICR Scale to abstain from using alcohol, ICR Scale for medication adherence, medication compliance,craving assessments

Time Frame

Throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bankole Johnson, DSc,MD,PhD

Organizational Affiliation

University of Maryland, Baltimore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Neurobehavioral Center

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

A IPD sharing plan has not been developed.

Learn more about this trial

Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

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