Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

NCT00890149 | Terminated Phase 2 DMC

• 2 other identifiers: HP-000630002R01AA010522-13
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Alcohol Abuse; Alcoholism

Keywords

alcohol abuse; binge drinking; severe drinking; alcoholism; heavy drinking

Outcome Measures

Primary Outcomes (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.

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

  Throughout the study

Secondary Outcomes (1)

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

  Throughout the study

Study Arms (2)

Ondansetron

EXPERIMENTAL

Ondansetron + BASICS Plus

Drug: Ondansetron; Behavioral: BASICS Plus

Placebo

PLACEBO COMPARATOR

Placebo + BASICS Plus

Drug: Placebo; Behavioral: BASICS Plus

Interventions

Ondansetron DRUG

Ondansetron (4ug/kg bid),

Also known as: Zofran

Ondansetron

Placebo DRUG

Placebo bid

Also known as: Sugar pill

Placebo

BASICS Plus BEHAVIORAL

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

Ondansetron; Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Please contact site for additional information

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Clinical Neurobehavioral Center

Columbia, Maryland, 21045, United States

Location

MeSH Terms

Conditions

Alcoholism; Binge Drinking

Interventions

Ondansetron; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol Drinking; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Carbohydrates

Study Officials

• Bankole Johnson, DSc,MD,PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

US (1)