Waterpipe SmokingNCT03253653
Assessing Toxicity of Waterpipe Tobacco Smoking
A study testing Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke in people with Waterpipe Smoking, run by San Diego State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Waterpipe Smoking
- What is being tested?
- Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 25 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female exclusive waterpipe tobacco smoker
- Smokes at least 1 waterpipe tobacco head per month
- Smokes waterpipe tobacco at home
- Age 21 years or older
- Adult male or female non-smoker
- Lived in a 'non-smoker home' at least in the last month
Show all 9Show fewer
- Age 21 years or older
- No smokers have lived in in the past month
- No visitors had smoked indoors/outdoors in the past month
Who cannot join
- Major physical/psychiatric illnesses
- Daily waterpipe smokers
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Behavioral Epidemiology and Community Health
San Diego, California, 92123
About this study
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, L-2-(acetylamino)-6-(2,5-dihydro-2-oxo-1H-pyrrol-1-yl)-1-hexanoic acid (Furan-BDA-NAL).
Read the detailed description
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 research assistants (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.
- Conditions
- Waterpipe Smoking
- Being tested
- Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke
- Keywords
- waterpipe, hookah, NNAL, SPMA, 1-HOP, Furan-BDA-NAL, Carbon monoxide, Pulmonary Function
- Medical subject headings
- Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smokeDevice
In a repeated measures design, 50 adult male and female exclusive WP tobacco smokers will smoke WP tobacco weekly over a 3-week study period with 3 WP smoking practices as follows: 1) using room temperature water in the WP jar, 2) adding ice cubes to the water in the WP jar, and 3) using a charcoal-free electronic WP head to heat the tobacco. Six Spot first morning urine samples will be provided by participants. Two urine samples per each of the 3 smoking sessions. Urine samples will be provided on the day of the WP tobacco smoking session and the following day. Physiological measures will be taken at Baseline during the office visit and before and after each of the 3 WP tobacco smoking sessions.
| Study group | Role | What they receive |
|---|---|---|
| Waterpipe smoking | Experimental | 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. Receives: Device: Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke |
| Control | No intervention | A total of 25 adult make and female nonsmokers will be recruited as a control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Cotinine Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
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.
Measured: 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.
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
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.
Measured: 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.
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
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.
Measured: 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.
Comparing Exhaled Carbon Monoxide Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
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
Measured: Assessment will be taken immediately before starting to smoke, and immediately at conclusion of each of the 2 smoking sessions.
Comparing Systolic Blood Pressure Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
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.
Measured: 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).
Comparing Diastolic Blood Pressure Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
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.
Measured: 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).
Comparing Heart Rate Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
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.
Measured: 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).
Assess Difference in Cotinine Levels Between (a) Non-smokers vs. (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
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.
Measured: 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.
Assess Difference in SPMA Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
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.
Measured: 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.
Assess Difference in 1-HOP Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
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.
Measured: 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.
Assess Difference in Exhaled Carbon Monoxide Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
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
Measured: 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.
Assess Difference in Systolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
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
Measured: 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.
Assess Difference in Diastolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
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
Measured: 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.
Assess Difference in Heart Rate Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
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
Measured: 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.
Assess Difference in Cotinine Levels Between (a) Non-smokers vs. (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
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.
Measured: 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.
Assess Difference in SPMA Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
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.
Measured: 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.
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
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.
Measured: 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.
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
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
Measured: 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.
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
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.
Measured: 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.
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
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.
Measured: 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.
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
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.
Measured: 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.
Secondary outcomes (10)
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.
The investigators will assess difference in urinary Furan-BDA-NAL levels between non-smokers and post a smoking session for waterpipe tobacco smokers. Furan-BDA-NAL is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples: for smokers, the day of the smoking session and the day following the smoking session; for non-smokers, the day of the home visit.
Measured: 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.
The investigators will assess difference in urinary Furan-BDA-Lys levels between non-smokers and post a smoking session for waterpipe tobacco smokers. Furan-BDA-Lysis a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples: for smokers, the day of the smoking session and the day following the smoking session; for non-smokers, the day of the home visit.
Measured: 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.
The investigators will assess difference in urinary Furan-NAC-BDA-NAL levels between non-smokers and post a smoking session for waterpipe tobacco smokers. Furan-NAC-BDA-NAL is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples: for smokers, the day of the smoking session and the day following the smoking session; for non-smokers, the day of the home visit.
Measured: 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.
The investigators will assess difference in urinary Furan-NAC-BDA-Lys levels between non-smokers and post a smoking session for waterpipe tobacco smokers. Furan-BNAC-BDA-Lys is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples: for smokers, the day of the smoking session and the day following the smoking session; for non-smokers, the day of the home visit.
Measured: 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.
The investigators will assess difference in urinary Furan-NAC-BDA-Lys sulfoxide levels between non-smokers and post a smoking session for waterpipe tobacco smokers. Furan-NAC-BDA-Lys sulfoxide is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples: for smokers, the day of the smoking session and the day following the smoking session; for non-smokers, the day of the home visit.
Measured: 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.
Investigators will assess difference between pre-smoking session levels of urinary Furan-BDA-NAL in waterpipe tobacco smokers and post that smoking session. Furan-BDA-NAL is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples, the day of the smoking session and the day following the smoking session.
Measured: Early morning on day 1 to early morning on day 2.
Assess Difference in Urinary Furan-BDA-Lys Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session.
Investigators will assess difference between pre-smoking session levels of urinary Furan-BDA-Lys in waterpipe tobacco smokers and post that smoking session. Furan-BDA-Lys is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples, the day of the smoking session and the day following the smoking session.
Measured: 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
Investigators will assess difference between pre-smoking session levels of urinary Furan-NAC-BDA-NAL in waterpipe tobacco smokers and post that smoking session. Furan-NAC-BDA-NAL is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples, the day of the smoking session and the day following the smoking session.
Measured: 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
Investigators will assess difference between pre-smoking session levels of urinary Furan-NAC-BDA-Lys in waterpipe tobacco smokers and post that smoking session. Furan-NAC-BDA-Lys is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples, the day of the smoking session and the day following the smoking session.
Measured: 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
Investigators will assess difference between pre-smoking session levels of urinary Furan-NAC-BDA-Lys sulfoxide in waterpipe tobacco smokers and post that smoking session. Furan-NAC-BDA-Lys sulfoxide is a metabolite of furan, a liver toxicant and carcinogen. It will be collected for laboratory assay using two first morning spot urine samples, the day of the smoking session and the day following the smoking session
Measured: Early morning on day 1 to early morning on day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start20 Oct 2017
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Waterpipe SmokingStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will employ a repeated measures design. A sample of 50 adult male and female exclusive WP smokers and a control sample of 25 male and female non-smokers will be recruited. Over a 3-week study, WP smokers will smoke one WP tobacco head during each of 3 separate WP smoking sessions with a 7-day washout period before each session. Session 1, WP smokers will smoke using 1 quick-light charcoal and room temperature water in the WP jar; Session 2, WP smokers will smoke using 1 quick-light charcoal but adding ice cubes to the water in the WP jar; Session 3, WP smokers will smoke WP tobacco without charcoal using an electric WP head and room temperature water. Physiological effects, carbon monoxide exposure and biomarkers of toxicants and carcinogens related to WP tobacco smoking practices will be compared.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Kassem, San Diego State University
- Investigators
- Nada Kassem, DrPH, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253653
- Sponsor's protocol ID
- R01DA042471-01
- Status last verified
- Mar 2025
- First submitted
- 7 Aug 2017
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kassem NO, Kassem NO, Liles S, Reilly E, Kas-Petrus F, Posis AIB, Hovell MF. Waterpipe device cleaning practices and disposal of waste associated with waterpipe tobacco smoking in homes in the USA. Tob Control. 2020 Feb;29(Suppl 2):s123-s130. doi: 10.1136/tobaccocontrol-2019-054959. Epub 2019 Jul 20.
PubMed 31326957
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Toxicity of Waterpipe Tobacco Smoking in Laboratory and Naturalistic Settings
- ClinicalTrials.gov ID
- NCT03253653
- Acronym / sponsor ID
- R01DA042471-01
- Conditions
- Waterpipe Smoking
- Keywords
- waterpipe, hookah, NNAL, SPMA, 1-HOP, Furan-BDA-NAL, Carbon monoxide, Pulmonary Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 research assistants (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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will employ a repeated measures design. A sample of 50 adult male and female exclusive WP smokers and a control sample of 25 male and female non-smokers will be recruited. Over a 3-week study, WP smokers will smoke one WP tobacco head during each of 3 separate WP smoking sessions with a 7-day washout period before each session. Session 1, WP smokers will smoke using 1 quick-light charcoal and room temperature water in the WP jar; Session 2, WP smokers will smoke using 1 quick-light charcoal but adding ice cubes to the water in the WP jar; Session 3, WP smokers will smoke WP tobacco without charcoal using an electric WP head and room temperature water. Physiological effects, carbon monoxide exposure and biomarkers of toxicants and carcinogens related to WP tobacco smoking practices will be compared.
| Arm | Type | Receives |
|---|---|---|
| Waterpipe smoking | Experimental | Device: Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smokeIn 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. |
| Control | No intervention | –A total of 25 adult make and female nonsmokers will be recruited as a control. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult male or female exclusive waterpipe tobacco smoker
- Smokes at least 1 waterpipe tobacco head per month
- Smokes waterpipe tobacco at home
- Age 21 years or older
- Adult male or female non-smoker
Key exclusion criteria (3 listed)
- Major physical/psychiatric illnesses
- Daily waterpipe smokers
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smokeIn a repeated measures design, 50 adult male and female exclusive WP tobacco smokers will smoke WP tobacco weekly over a 3-week study period with 3 WP smoking practices as follows: 1) using room temperature water in the WP jar, 2) adding ice cubes to the water in the WP jar, and 3) using a charcoal-free electronic WP head to heat the tobacco. Six Spot first morning urine samples will be provided by participants. Two urine samples per each of the 3 smoking sessions. Urine samples will be provided on the day of the WP tobacco smoking session and the following day. Physiological measures will be taken at Baseline during the office visit and before and after each of the 3 WP tobacco smoking sessions. | Device | Waterpipe smoking |
Primary outcome
Comparing Cotinine Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 SPMA Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Exhaled Carbon Monoxide Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
Time frame: 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 Systolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Early morning on day 1 to early morning on day 2.
Assess Difference in Urinary Furan-BDA-Lys Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Early morning on day 1 to early morning on day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31326957Kassem NO, Kassem NO, Liles S, Reilly E, Kas-Petrus F, Posis AIB, Hovell MF. Waterpipe device cleaning practices and disposal of waste associated with waterpipe tobacco smoking in homes in the USA. Tob Control. 2020 Feb;29(Suppl 2):s123-s130. doi: 10.1136/tobaccocontrol-2019-054959. Epub 2019 Jul 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada Kassem, DrPH principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke in people with Waterpipe Smoking, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing Cotinine Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head (time frame: 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.). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03253653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.