Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

University of Maryland Baltimore (UMB)

Status and phase: Terminated; Phase 2

Conditions: Alcoholism; Alcohol Abuse

Treatments: Drug: Ondansetron; Drug: Placebo; Behavioral: BASICS Plus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00890149

2R01AA010522-13 (U.S. NIH Grant/Contract)

HP-00063000

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Ondansetron

Experimental group

Description:

Ondansetron + BASICS Plus

Treatment:

Behavioral: BASICS Plus

Drug: Ondansetron

Placebo

Placebo Comparator group

Description:

Placebo + BASICS Plus

Treatment:

Behavioral: BASICS Plus

Drug: Placebo