Clinical trial NCT00890149: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alcohol Abuse
Alcoholism
Keywords: alcohol abuse
binge drinking
severe drinking
alcoholism
heavy drinking
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2009-04-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Throughout the study
Secondary outcomes:
measure: Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Clinical Neurobehavioral Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Bankole Johnson, DSc,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: