Waterpipe Smoking Clinical Trial
Official title:
Assessing Toxicity of Waterpipe Tobacco Smoking in Laboratory and Naturalistic Settings
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 Furan-BDA-NAL.
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.
A charcoal-free electrically heated WP head is commercially available. Users were satisfied
with this device because they did not have to deal with charcoal fire hazardous ambers and
ashes, in addition to enjoying the feeling of reduced harm. WP smokers normally use room
temperature water in the WP jar. However, other liquid media are gaining in popularity.
According to anecdotal evidence, "adding ice cubes in the WP jar has an enjoyable cooling
effect to the inhaled smoke". Smokers practice adding ice cubes at home, and for an extra
charge hookah lounges provide this option for customers. Toxic chemicals in WP tobacco smoke
include cotinine, a metabolite of the addictive drug 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; and Furan-BDA-NAL, a metabolite of the carcinogen furan.
METHODS. will compare exhaled CO, pulmonary functions, blood pressure, heart rate and
respiratory rate, and urinary levels of cotinine, NNAL, SPMA, and 1-HOP in first void WP
smoker urine samples the morning of, and the morning after a WP smoking session across 3
smoking practices. The investigators will recruit a sample of 50 adult male and female
exclusive WP smokers and a control sample of 25 male and female non-smokers. Participants
will be recruited and qualified via random intercept screen interviews from San Diego County,
California communities. Over a 3-week study period, WP smokers will smoke one WP tobacco head
(10g) of Starbuzz during 3 separate sessions with a 7-day washout period before each session
in their home in a natural setting: Week 1-Session 1, WP smokers will smoke using 1
quick-light charcoal and room temperature water in the WP jar, Week 2-Session 2, WP smokers
will smoke using 1 quick-light charcoal but adding ice cubes to the water in the WP jar, Week
3-Session 3, WP smokers will smoke WP tobacco without charcoal using the electric WP head and
room temperature water. The investigators will collect the following forms: a) Tobacco Use
History; b) 3-week Tobacco Use and Exposure Diaries; c) WP Smoking Session Day and Exposure
Form; and will measure d) CO exposure: Micro+ Smokerlyzer® CO monitor will be used for
exhaled CO two minutes pre and post each smoking session; e) Pulmonary function testing and
measuring blood pressure, heart rate and respiratory rate pre and post each smoking session;
and f) 6 first morning urine samples: pre and post the 3 sessions to measure urinary
cotinine, NNAL, 1-HOP, SPMA, and Furan-BDA-NAL. Efforts will be made to recruit equal samples
of males and females. Flexible scheduling for study activities where applicable. Proration of
incentives will apply for completed activities.
The 3-Week Study period: comprised of 3 WP smoking sessions with 7-day wash-out periods
WP Smoking Session 1. Day 1 - Office Visit: The Office Visit is expected to take between 60
and 90 minutes where potential participants will be trained on the study activities. Consent
will be obtained, study forms will be completed, and study related materials such as forms
and urine cups will be provided. Scheduling will be arranged for the 3 WP smoking sessions
and corresponding home visits. Saliva Test: Trained by the PI, the RAs will use NicAlert, an
accurate and valid commercial semi-quantitative instant saliva cotinine test, to validate
non-smoking status, which the investigators used successfully in their previous studies. The
following physiological baseline data will be collected: pulmonary functions, blood pressure,
heart rate and respiratory rate. Days 2 - 6: The RAs will contact participants by phone on
the 4th day to confirm adherence to the 7-wash-out period and diaries, and on the 6th day to
remind participants to collect the first morning urine sample on day 7, and to arrange for a
home visit for the first WP smoking session. Day 7: WP smoking session 1. WP smokers will
provide one first morning urine sample and store it in their refrigerator (freezer section).
WP smokers will smoke WP tobacco (10 grams) as they normally do using charcoal and room
temperature water in the water jar. The RAs will collect expired CO levels 2 minutes before
and 2 minutes after concluding smoking, and will measure pulmonary functions, blood pressure,
heart rate and respiratory rate thereafter. Day 8: Participants will provide a first morning
urine sample. The RAs will pick up the 2 urine samples (frozen in a cooler to transfer them
to the research center laboratory), and arrange for the 2nd WP smoking session home visit,
provide forms, urine cups package for week 2 of the study. WP Smoking Session 2. Days 1
through 7 are similar to session 1 with the exception that the RAs will add one tray of ice
cubes and water in the WP jar. The RAs will arrange for a training session to use the
charcoal-free electrically heated WP head. WP Smoking Session 3. Days 1 through 7 are similar
to session 1 using room temperature water in the WP jar, however using the charcoal-free
electrically heated WP head instead of using charcoal. During the last visit, the day after
the 3rd smoking session, the RAs will interview participants to complete the Illnesses and
Health Care History Form, pick up the final urine samples, and thank the participants.
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