N/A
N=85
Assessing Toxicity of Waterpipe Tobacco Smoking
Waterpipe Smoking
Bottom Line
View on ClinicalTrials.gov: NCT03253653 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Comparing Cotinine Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head — 34.9; 26.4 ng/mL — p=0.115
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- San Diego State University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparing Cotinine Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head |
34.9; 26.4 | 0.115 |
| PRIMARY 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 |
1.35; 0.34 | 0.619 |
| PRIMARY 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 |
0.47; 0.48 | 0.085 |
| PRIMARY Comparing Exhaled Carbon Monoxide Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head |
107; 3.5 | <0.001 sig |
| PRIMARY Comparing Systolic Blood Pressure Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head |
122; 120 | 0.253 |
| PRIMARY Comparing Diastolic Blood Pressure Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head |
79; 78 | 0.315 |
| PRIMARY Comparing Heart Rate Pre-to-post Change Between 2 Waterpipe Smoking Sessions: Heating Waterpipe Tobacco by (a) Charcoal vs (b) an Electric Head |
80; 77 | 0.002 sig |
| PRIMARY Assess Difference in Cotinine Levels Between (a) Non-smokers vs. (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal |
34.9; 0.02 | <0.001 sig |
| PRIMARY Assess Difference in SPMA Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal |
1.35; 0.17 | <0.001 sig |
| PRIMARY Assess Difference in 1-HOP Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal |
0.47; 0.23 | .010 sig |
| PRIMARY Assess Difference in Exhaled Carbon Monoxide Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal |
107; 2.8 | <0.001 sig |
| PRIMARY Assess Difference in Systolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal |
122; 117 | 0.192 |
| PRIMARY Assess Difference in Diastolic Blood Pressure Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal |
79; 75 | 0.033 sig |
| PRIMARY Assess Difference in Heart Rate Levels Between (a) Non-smokers and (b) Smokers Post a Waterpipe Smoking Session, Using Tobacco Heated by Charcoal |
80; 76 | 0.223 |
| PRIMARY Assess Difference in Cotinine Levels Between (a) Non-smokers vs. (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head |
26.4; 0.02 | <0.001 sig |
| PRIMARY Assess Difference in SPMA Levels Between (a) Non-smokers and (b) Smokers After a Waterpipe Smoking Session, Using Tobacco Heated by an Electric Head |
0.34; 0.17 | 0.212 |
| PRIMARY 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 |
0.48; 0.23 | 0.007 sig |
| PRIMARY 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 |
3.5; 2.8 | 0.006 sig |
| PRIMARY 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 |
120; 117 | 0.406 |
| PRIMARY 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 |
78; 75 | 0.142 |
| PRIMARY 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 |
77; 76 | 0.551 |
| SECONDARY 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. |
131; 112 | 0.431 |
| SECONDARY Assess Difference in Urinary Furan-BDA-Lys Between Levels at Post Waterpipe Tobacco Smoking Versus Non-smoker Levels. |
47; 44 | 0.515 |
| SECONDARY 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. |
0.05; 0.01 | 0. 017 sig |
| SECONDARY 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. |
4.0; 2.4 | 0.199 |
| SECONDARY Assess Difference in Urinary Furan-NAC-BDA-Lys Sulfoxide' Between Levels at Post Waterpipe Tobacco Smoking Versus Non-smoker Levels. |
3.1; 2.1 | 0.002 sig |
| SECONDARY Assess Difference in Urinary Furan-BDA-NAL Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session. |
128; 131 | 0.896 |
| SECONDARY Assess Difference in Urinary Furan-BDA-Lys Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session. |
42; 47 | 0.717 |
| SECONDARY Assess Difference in Urinary Furan-NAC-BDA-NAL Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session |
0.06; 0.05 | 0.026 sig |
| SECONDARY Assess Difference in Urinary Furan-NAC-BDA-Lys Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session |
4.0; 4.0 | 0.702 |
| SECONDARY Assess Difference in Urinary Furan-NAC-BDA-Lys Sulfoxide Between Levels Pre the Waterpipe Tobacco Smoking Session vs Post the Waterpipe Tobacco Smoking Session |
3.4; 3.1 | 0.025 sig |
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).
Eligibility Criteria
Inclusion Criteria for a Waterpipe Tobacco Smoker
- 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
Inclusion Criteria for a Non-Smoker
- Adult male or female non-smoker
- Lived in a 'non-smoker home' at least in the last month
- Age 21 years or older
Inclusion Criteria for a Non-Smoker Home
- No smokers have lived in in the past month
- No visitors had smoked indoors/outdoors in the past month
Exclusion Criteria
- Major physical/psychiatric illnesses
- Daily waterpipe smokers
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT03253653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.