Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes Through a Cancer Prevention and Biology Collaborative
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Binary indicator of study completion
研究概览
简要总结
This pilot randomized behavioral study evaluates the feasibility, adherence, and acceptability of an intervention to restrict flavored ready-to-drink (RTD) alcoholic beverages among young adults who regularly use both alcohol and e-cigarettes. Participants will complete a 2-week baseline period followed by a 2-week intervention period. Participants will be randomized to either avoid flavored RTD alcoholic beverages or continue their usual alcohol consumption.
Primary outcomes include feasibility, adherence, acceptability. Secondary outcomes include preliminary efficacy of flavored RTD restriction on alcohol consumption and e-cigarette use measured through daily electronic diaries; biomarkers of alcohol and nicotine exposure, including urinary ethyl glucuronide (EtG), urinary cotinine, and blood phosphatidylethanol (PEth).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being between 21 and 29 years old,
- •currently moderate alcohol drinking (i.e., at least 4 standard drinks per week in the past 3 months), with flavored RTD beverages comprising at least 50% of total alcohol consumption,
- •current regular e-cigarette use (i.e., 20 out of 30 days every month in the past 3 months),
- •English-speaking,
- •access to a smartphone for diary reporting.
排除标准
- •Being in current cessation treatment for substances of interest in the study,
- •Having serious or unstable psychiatric or medical conditions,
- •Being pregnant or breastfeeding,
- •Use of other psychoactive substances unless prescribed and stable.
- •Inability or unwillingness of the subject to give informed consent
研究组 & 干预措施
No-restriction Control Group
Participants assigned to the no-restriction control group will continue their usual alcohol and e-cigarette consumption.
Restriction Group
Participants assigned to the restriction group will be instructed to avoid flavored ready-to-drink alcoholic beverages for 2 weeks. They will not be asked to avoid unflavored alcoholic beverages or any e-cigarettes.
干预措施: Flavored Ready-to-Drink alcoholic beverage use restriction (Behavioral)
结局指标
主要结局
Binary indicator of study completion
时间窗: From enrollment to the end of treatment at 4 weeks
The primary endpoint is a binary indicator of completion of at least 75% of study visits and 75% of surveys.
次要结局
- Number of standard drinks consumed(From enrollment to the end of treatment at 4 weeks.)
- Number of vaping sessions(From enrollment to the end of treatment at 4 weeks.)
- Blood phosphatidylethanol 16:0/18:1 (PEth)(Week -2, at enrollment.)
- Urinary ethyl glucuronide (EtG)(Week -1, Week 0, Week 1, and Week 2 Study Visits.)
- Urinary cotinine concentrations(Week -1, Week 0, Week 1 and Week 2 Study Visits)
研究者
Roberta Freitas Lemos
Assistant Professor-Faculty
Medical University of South Carolina