NCT03096860已完成不适用
Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total volume smoke inhaled
研究概览
简要总结
The purpose of the current study is to investigate in a prospective randomized cross-over trial, the impact of alcohol versus a placebo drink on smoking behavior and topography (duration and frequency of puffing), abuse liability, and toxicity. It is hypothesized that drinking alcohol before smoking will be associated with longer puffs and shorter duration between puffs and greater abuse liability and toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Report using hookah at least 1 time per month over the past 6 months
- •Are at least 21 years old
- •Speak and understand English
- •Do not currently suffer from lung disease including asthma, CF, or COPD
- •Do not currently suffer from heart disease
- •Are not currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study
- •No current, regular use of >5 cigarettes or other tobacco products (e.g., e-cig, cigar, etc.) per month.
- •No current marijuana use > 5 times per month
- •No use of illicit drugs during the past 30 days
- •willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours and abstain from alcohol for at least 24 hours prior to each of the two sessions
- •Live within 25 miles of the study location.
- •Have a friend who is eligible and willing to participate.
- •Consume 2 or more or one or more drinks per episode for men and women, respectively
- •Drink alcohol at least one time per week
- •Not currently be seeking treatment for alcohol use
- •Able to answer at least two hookah-specific screening questions from the screener.
排除标准
- •Hookah use less than one time per month over the past 6 months
- •Under the age of 21
- •Unwilling to abstain from alcohol for 24 hours and tobacco and nicotine products 12 hours prior to each study visit
- •Live more than 25 miles from the study location
- •Pregnant or breast feeding or plan to become pregnant or begin breast feeding at any point in the study -
研究组 & 干预措施
Alcohol consumption and hookah
Experimental
干预措施: Active alcohol consumption (Other)
Placebo consumption and hookah
Placebo Comparator
干预措施: Placebo consumption (Other)
结局指标
主要结局
Total volume smoke inhaled
时间窗: up to 2 hours
hookah topography
次要结局
未报告次要终点
研究者
Eleanor Leavens
Principal Investigator
Oklahoma State University
研究点 (2)
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