Assessing Toxicity of Waterpipe Tobacco Smoking

NCT03253653 | Completed Results DMC FDA Device

• 1 other identifier: R01DA042471-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Waterpipe Smoking

Keywords

waterpipe; hookah; NNAL; SPMA; 1-HOP; Furan-BDA-NAL; Carbon monoxide; Pulmonary Function

Outcome Measures

Primary Outcomes (21)

• 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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

Study Arms (2)

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.

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.

Interventions

Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke DEVICE

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.

Waterpipe smoking

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age 21 years or older
• No smokers have lived in in the past month
• No visitors had smoked indoors/outdoors in the past month

You may not qualify if:

• Major physical/psychiatric illnesses
• Daily waterpipe smokers
• Pregnant women

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

Center for Behavioral Epidemiology and Community Health

San Diego, California, 92123, United States

Location

Related Publications (1)

• 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.

  PMID: 31326957 DERIVED

MeSH Terms

Conditions

Water Pipe Smoking

Condition Hierarchy (Ancestors)

Pipe Smoking; Smoking; Behavior

Limitations and Caveats

Smoking duration was shorter for electric head vs charcoal, reducing smoke exposure. WPT smokers smoked alone, not socially, generating less sidestream smoke exposure. Spot urine samples may have underestimated peak levels of benzene and pyrene, due to half-lifes differing among metabolites. Participant use of one type of charcoal, tobacco, WP hoses, and electric heater; convenience sampling; n=50; and participant age 21-35, suggest data may not be representative of WPT smokers in general.

Results Point of Contact

• Title: Dr. Nada Kassem
• Organization: San Diego State University Research Foundation

Nkassem@sdsu.edu

619-370-7488

Study Officials

• Nada Kassem, DrPH

  San Diego State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 18, 2017
• Study Start: October 20, 2017
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)