Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Please contact site for additional information
研究组 & 干预措施
Placebo
Placebo + BASICS Plus
干预措施: Placebo (Drug)
Ondansetron
Ondansetron + BASICS Plus
干预措施: Ondansetron (Drug)
Ondansetron
Ondansetron + BASICS Plus
干预措施: BASICS Plus (Behavioral)
Placebo
Placebo + BASICS Plus
干预措施: BASICS Plus (Behavioral)
结局指标
主要结局
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.
时间窗: Throughout the study
Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping
次要结局
- Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change(Throughout the study)