Assessing Toxicity of Waterpipe Tobacco Smoking in Laboratory and Naturalistic Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Comparing Cotinine Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
研究概览
简要总结
Waterpipe smoking is a tobacco use method in which smoke passes through a partially-filled water jar. Burning charcoal heats the waterpipe tobacco which produces the smoke that the user inhales. Waterpipe smoking was associated with increased risk for coronary heart and pulmonary diseases. This Waterpipe Study will inform the FDA on regulating waterpipe tobacco products and reduce the harm of it use. This study will be conducted at homes of hookah smokers, in natural settings, aimed to determine the effects of waterpipe smoking practices on physiological injury markers and biomarkers of toxicity of waterpipe tobacco smoking. The investigators will employ a repeated measures design. The investigators will recruit a sample of 50 adult male and female exclusive waterpipe smokers and a control sample of 25 male and female non-smokers via intercept interviews from San Diego County, California communities. Waterpipe smokers will smoke one waterpipe tobacco head (10g) of Starbuzz during 3 separate sessions with a 7-day washout period before each session, as follows: Session 1, Smoking waterpipe tobacco using 1 quick-light charcoal and room temperature water in the waterpipe jar, Session 2, Smoking waterpipe tobacco using 1 quick-light charcoal and adding ice cubes to the water in the waterpipe jar, and Session 3, Smoking waterpipe tobacco without charcoal using a charcoal-free electrically heated waterpipe head to heat the tobacco, and room temperature water in the waterpipe jar. The following data will be collected: a) Tobacco Use History, b) 4-week Tobacco Exposure Diary, c) Waterpipe Use Session Form, d) Carbon monoxide (CO) exposure: Micro+ Smokerlyzer® CO monitor will be used for exhaled CO pre and 2 minutes post each smoking session, e) Pulmonary function testing and measuring blood pressure, heart rate and respiratory rate, and f) 6 first morning urine samples: pre and post the 3 sessions to measure urinary cotinine, a metabolite of nicotine, 4-(methylnitrosamino)-1- (3-pyridyl)-1-butanol (NNAL) and NNAL-glucuronides (total NNAL), metabolites of the lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), 1-hydroxypyrene (1-HOP), a metabolite of the genotoxic carcinogen pyrene, and S-phenylmercapturic acid (SPMA), a metabolite of the human hematotoxicant and leukemogen benzene. The investigators will explore exposure levels to furan, a liver toxicant and carcinogen, among waterpipe smokers via measuring its urinary metabolite, L-2-(acetylamino)-6-(2,5-dihydro-2-oxo-1H-pyrrol-1-yl)-1-hexanoic acid (Furan-BDA-NAL).
详细描述
Globally, 1 in 3 adults or 1.2 billion people smoke. The World Health Organization (WHO) estimated that tobacco is responsible for the death of 1 in 10 adults worldwide, about 6 million premature deaths each year. In the United States (U.S.), cigarette smoking is responsible for more than 480,000 deaths per year, including nearly 42,000 deaths resulting from secondhand smoke exposure. Tobacco use is the single leading most preventable cause of disease, disability, and mortality in the U.S. Tobacco research tends to focus on cigarettes; however, the rise in waterpipe (WP) tobacco use globally warrants studying all aspects of its toxicity. In 2005, the WHO called for a better understanding of WP tobacco smoking. In 2007, the American Lung Association labeled WP smoking as an emerging deadly trend. WP tobacco use was associated with increased risk for Chronic obstructive pulmonary disease (COPD), heart diseases, lung cancers, oral and esophageal cancers.
COPD is a major public health problem leading to airflow obstruction. In the U.S., tobacco smoke is a key factor in the development of COPD, which was the third leading cause of death in the U.S. in 2014. WP smoking decreases respiratory quality of life in adults. Studies found that pulmonary function following WP smoking was impaired as measured by forced expiratory volume (FEV1), forced vital capacity (FVC), FEV1/FVC, and Forced Expiratory Flow (FEF25-75%). Studies investigating acute cardiovascular injury markers due to WP smoking showed significant increases in heart rate, and in systolic and diastolic blood pressure.
In 2014, the U.S. Food and Drug Administration (FDA) initiated regulation WP tobacco. The FDA proposed that the manufacturers of WP tobacco disclose to the FDA their products' ingredients and report harmful and potentially harmful constituents (HPHCs). A review study showed that exposures to HPHCs are 10-100 times higher in WP tobacco smoke than in cigarette smoke. To inform the FDA on the regulation of WP tobacco products, and reduce the harm of it use, the investigators propose a Waterpipe Project in a natural setting to determine the differential effects of WP smoking practices on physiological injury markers, and biomarkers of toxicants and carcinogens.
Worldwide, the WP is used in Africa, Asia, China, India, and the Middle East. Adolescents and young adults in the U.S. are experimenting with WP smoking. The 2014 U.S. National College Health Assessment II found that nearly one third of U.S. undergraduate college students (38.2% of men and 31.4% of women), reported ever using WP tobacco, and 11.6% of men and 8.3% of women reported current use (past 30 days). Among high school students, the 2013 U.S. National Youth Tobacco Survey showed that 15.1% of boys and 13.5% of girls reported ever WP use.
The WP (hookah) consists of a head, a body, a hose, and a water jar. The tobacco is placed in the head and covered with a perforated aluminum foil to allow air-flow. Burning charcoal is placed on top of the aluminum foil. Upon deep inhalation via the WP hose, suction forces hot air through the head, heating and combusting the tobacco to produce the smoke that is forced down the WP body, into and out of the water in the airtight jar, and through the hose into the smoker's mouth and respiratory system. Smokers inhale charcoal toxicant emissions in addition to those from the WP tobacco. Charcoal combustion contributes greatly to benzene, carbon monoxide (CO) and carcinogenic yields. CO is a smoke toxicant that reduces the blood's ability to transport oxygen to various organs, including the brain, and can cause dizziness, headache, syncope and nausea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Waterpipe smoking
In a repeated measures design, 50 adult male and female exclusive WP smokers will smoke WP tobacco weekly over a 3-week study period with 3 WP smoking practices.
干预措施: Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke (Device)
Control
A total of 25 adult make and female nonsmokers will be recruited as a control.
结局指标
主要结局
Comparing Cotinine Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
时间窗: On 2 days for each of two smoking sessions, smokers will provide 2 first morning spot urine samples--one urine sample on the morning of the day of the smoking session, and one urine sample on the morning of the following day.
Investigators will assess change in creatinine-adjusted urinary levels of cotinine (a metabolite of the addictive drug nicotine) in ng/mL, from pre-to post, at each of 2 waterpipe tobacco smoking sessions. For each of the 2 smoking sessions, smokers will provide two first morning spot urine samples--the day of the smoking session and the following morning. The two waterpipe tobacco smoking sessions are as follows: 1) using charcoal to heat the tobacco, and 2) using a charcoal-free electronic waterpipe head to heat the tobacco.
Comparing S-phenyl-mercapturic Acid (SPMA) Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
时间窗: On 2 days for each of two smoking sessions, smokers will provide 2 first morning spot urine samples--one urine sample on the morning of the day of the smoking session, and one urine sample on the morning of the following day.
Investigators will assess change in creatinine-adjusted urinary levels of SPMA (a metabolite of the human hematotoxicant and leukemogen benzene) in pmol/mL, from pre-to post, at each of 2 waterpipe tobacco smoking sessions. For each of the 2 smoking sessions, smokers will provide two first morning spot urine samples--the day of the smoking session and the following morning. The two waterpipe tobacco smoking sessions are as follows: 1) using charcoal to heat the tobacco, and 2) using a charcoal-free electronic waterpipe head to heat the tobacco.
Comparing 1-hydroxypyrene (1-HOP) But Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
时间窗: On 2 days for each of two smoking sessions, smokers will provide 2 first morning spot urine samples--one urine sample on the morning of the day of the smoking session, and one urine sample on the morning of the following day.
Investigators will assess change in creatinine-adjusted urinary levels of 1-HOP (a metabolite of the genotoxic carcinogen pyrene) in pmol/ML, from pre-to post, at each of 2 waterpipe tobacco smoking sessions. For each of the 2 smoking sessions, smokers will provide two first morning spot urine samples--the day of the smoking session and the following morning. The two waterpipe tobacco smoking sessions are as follows: 1) using charcoal to heat the tobacco, and 2) using a charcoal-free electronic waterpipe head to heat the tobacco.
Comparing Exhaled Carbon Monoxide Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
时间窗: Assessment will be taken immediately before starting to smoke, and immediately at conclusion of each of the 2 smoking sessions.
measuring exhaled CO using a Micro+ Smokerlyzer® carbon monoxide (CO) monitor for exhaled CO before and after each of two waterpipe tobacco smoking sessions, investigators will determine the differential change, pre-to-post waterpipe tobacco smoking, between heating by charcoal vs heating by electric head
Comparing Systolic Blood Pressure Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration=31 min).
The investigators will determine the differential effects of WP smoking practices on change in systolic blood pressure in mm/Hg after each of two WP smoking sessions: 1) using charcoal to heat the tobacco, and 2) using a charcoal-free electronic waterpipe head to heat the tobacco.
Comparing Diastolic Blood Pressure Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration=31 min).
The investigators will investigate the differential effects of WP smoking practices on change in diastolic blood pressure in mm/Hg after each of two WP smoking sessions: 1) using charcoal to heat the tobacco, and 2) using a charcoal-free electronic waterpipe head to heat the tobacco.
Comparing Heart Rate Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration=31 min).
The investigators will investigate the differential effects of WP smoking practices on change in heart rate in beats per minute after each of two WP smoking sessions: 1) using charcoal to heat the tobacco, and 2) using a charcoal-free electronic waterpipe head to heat the tobacco.
Assess Difference in Cotinine Levels Between (a) Non-smokers vs. (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
时间窗: For smokers: Early morning on the smoking session day to early morning the day after. For non-smokers: early in the morning of the home visit.
Investigators will assess change in creatinine-adjusted urinary levels of cotinine (a metabolite of nicotine) in ng/mL, For a smoking session using charcoal to heat the tobacco, waterpipe smokers will provide two first morning spot urine samples--the morning of the day of the smoking session and the morning of the following day. The investigators will assess difference in urinary cotinine levels between (a) non-smokers vs. (b) waterpipe tobacco smokers after the waterpipe smoking session.
Assess Difference in Exhaled Carbon Monoxide Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
时间窗: For the smokers: Assessment will be taken immediately before starting to smoke, and immediately at conclusion of the smoking session. For the non-smokers: Assessment will be taken at the home visit.
measuring exhaled carbon monoxide levels before and after the waterpipe tobacco smoking session, investigators will compare the levels between (a) non-smokers and (b) waterpipe tobacco smokers after their smoking session
Assess Difference in SPMA Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
时间窗: For smokers: Early morning on the smoking session day to early morning the day after. For non-smokers: early in the morning of the home visit.
Investigators will assess change in creatinine-adjusted levels of SPMA (a metabolite of the human hematotoxicant and leukemogen benzene) in pmol/mL, For a smoking session using charcoal to heat the tobacco, waterpipe smokers will provide two first morning spot urine samples--the morning of the day of the smoking session and the morning of the following day. The investigators will assess difference in urinary cotinine levels between (a) non-smokers vs. (b) waterpipe tobacco smokers after the waterpipe smoking session.
Assess Difference in 1-HOP Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
时间窗: For smokers: Early morning on the smoking session day to early morning the day after. For non-smokers: early in the morning of the home visit.
Investigators will assess change in creatinine-adjusted urinary levels of 1-HOP (metabolite of the genotoxic carcinogen pyrene in pmol/mL, For a smoking session using charcoal to heat the tobacco, waterpipe smokers will provide two first morning spot urine samples--the morning of the day of the smoking session and the morning of the following day. The investigators will assess difference in urinary cotinine levels between (a) non-smokers vs. (b) waterpipe tobacco smokers after the waterpipe smoking session.
Assess Difference in Exhaled Carbon Monoxide Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
时间窗: For the smokers: Assessment will be taken immediately before starting to smoke, and immediately at conclusion of each of the smoking session. For the non-smokers: Assessment will be taken at the home visit.
measuring exhaled CO using a Micro+ Smokerlyzer® CO monitor for exhaled CO before and after the heating by charcoal waterpipe tobacco smoking session, investigators will compare the levels between (a) non-smokers and (b) waterpipe tobacco smokers after their smoking session
Assess Difference in Systolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration =31 min), or at one point during the non-smoker home visit.
measuring systolic blood pressure levels before and after the waterpipe tobacco smoking session, investigators will compare the levels between (a) non-smokers and (b) waterpipe tobacco smokers after their smoking session
Assess Difference in Diastolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration =31 min), or at one point during the non-smoker home visit.
measuring diastolic blood pressure levels before and after the waterpipe tobacco smoking session, investigators will compare the levels between (a) non-smokers and (b) waterpipe tobacco smokers after their smoking session
Assess Difference in Heart Rate Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration =31 min), or at one point during the non-smoker home visit.
measuring heart rate levels before and after the waterpipe tobacco smoking session, investigators will compare the levels between (a) non-smokers and (b) waterpipe tobacco smokers after their smoking session
Assess Difference in Cotinine Levels Between (a) Non-smokers vs. (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
时间窗: For smokers: Early morning on the smoking session day to early morning the day after. For non-smokers: early in the morning of the home visit.
Investigators will assess creatinine-adjusted urinary levels of cotinine (a metabolite of nicotine) in ng/mL. For a smoking session using an electric head to heat the tobacco, waterpipe smokers will provide two first morning spot urine samples--the morning of the day of the smoking session and the morning of the following day. The investigators will compare (a) non-smoker levels with (b) waterpipe tobacco smoker levels after their waterpipe smoking session.
Assess Difference in SPMA Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
时间窗: For smokers: Early morning on the smoking session day to early morning the day after. For non-smokers: early in the morning of the home visit.
Investigators will assess creatinine-adjusted urinary levels of SPMA (a metabolite of benzene) in pmol/mL. For a smoking session using an electric head to heat the tobacco, waterpipe smokers will provide two first morning spot urine samples--the morning of the day of the smoking session and the morning of the following day. The investigators will compare (a) non-smoker levels with (b) waterpipe tobacco smoker levels after their waterpipe smoking session.
Assess Difference in 1-HOP Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
时间窗: For smokers: Early morning on the smoking session day to early morning the day after. For non-smokers: early in the morning of the home visit.
Investigators will assess creatinine-adjusted urinary levels of 1-HOP (a metabolite of pyrene, a polycyclic aromatic hydrocarbon) pmol/ML. For a smoking session using an electric head to heat the tobacco, waterpipe smokers will provide two first morning spot urine samples--the morning of the day of the smoking session and the morning of the following day. The investigators will compare (a) non-smoker levels with (b) waterpipe tobacco smoker levels after their waterpipe smoking session.
Assess Difference in Systolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration =31 min), or at one point during the non-smoker home visit.
For a smoking session using an electric head to heat the tobacco, investigators will measure systolic blood pressure levels before and after the waterpipe tobacco smoking session, and compare (a) non-smoker levels with (b) waterpipe tobacco smoker levels after their waterpipe smoking session.
Assess Difference in Diastolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration=31 min), or at one point during the non-smoker home visit.
For a smoking session using an electric head to heat the tobacco, investigators will measure diastolic blood pressure levels before and after the waterpipe tobacco smoking session, and compare (a) non-smoker levels with (b) waterpipe tobacco smoker levels after their waterpipe smoking session.
Assess Difference in Heart Rate Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
时间窗: Systolic & diastolic blood pressure and heart rate were assessed multiple times (at intervals>1 min) and averaged. Assessments were at the start and end of each smoking session (mean duration =31 min), or at one point during the non-smoker home visit.
For a smoking session using an electric head to heat the tobacco, investigators will measure heart rate levels before and after the waterpipe tobacco smoking session, and compare (a) non-smoker levels with (b) waterpipe tobacco smoker levels after their waterpipe smoking session.
次要结局
- Assess Difference in Urinary Furan-BDA-Lys Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session.(Early morning on day 1 to early morning on day 2)
- Assess Difference in Urinary L-2-(Acetylamino)-6-(2,5-dihydro-2-oxo-1H-pyrrol-1-yl)-1-hexanoic Acid (Furan-BDA-NAL) Between Levels at Post Waterpipe Tobacco Smoking Versus Non-smoker Levels.(For smokers: Early morning on day 1 to early morning on day 2. For non-smokers: early in the morning of the home visit.)
- Assess Difference in Urinary Furan-BDA-Lys Between Levels at Post Waterpipe Tobacco Smoking Versus Non-smoker Levels.(For smokers: Early morning on day 1 to early morning on day 2. For non-smokers: early in the morning of the home visit.)
- Assess Difference in Urinary N-acetyl-S-[1-(5-acetylamino-5-carboxylpentyl)-1H-pyrrol-3-yl]-L-cysteine (Furan-NAC-BDA-NAL) Between Levels at Post Waterpipe Tobacco Smoking Versus Non-smoker Levels.(For smokers: Early morning on day 1 to early morning on day 2. For non-smokers: early in the morning of the home visit.)
- Assess Difference in Urinary N-acetyl-S-[1-(5-amino-5-carboxylpentyl)-1H-pyrrol-3-yl]-L-cysteine (Furan-NAC-BDA-Lys) Between Levels at Post Waterpipe Tobacco Smoking Versus Non-smoker Levels.(For smokers: Early morning on day 1 to early morning on day 2. For non-smokers: early in the morning of the home visit.)
- Assess Difference in Urinary Furan-NAC-BDA-Lys Sulfoxide' Between Levels at Post Waterpipe Tobacco Smoking Versus Non-smoker Levels.(For smokers: Early morning on day 1 to early morning on day 2. For non-smokers: early in the morning of the home visit.)
- Assess Difference in Urinary Furan-BDA-NAL Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session.(Early morning on day 1 to early morning on day 2.)
- Assess Difference in Urinary Furan-NAC-BDA-NAL Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session(Early morning on day 1 to early morning on day 2)
- Assess Difference in Urinary Furan-NAC-BDA-Lys Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session(Early morning on day 1 to early morning on day 2)
- Assess Difference in Urinary Furan-NAC-BDA-Lys Sulfoxide Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session(Early morning on day 1 to early morning on day 2)
研究者
Nada Kassem
PI
San Diego State University