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Completed

NCT Number: NCT05453773

Hookah Additive Research to Inform Product Standards

This clinical trial evaluates how the content of waterpipe (WP) tobacco affects the appeal, puffing behavior, and toxicity of WP tobacco smoking. The data from the proposed study will provide direct links between WP tobacco's primary additives (sugars and humectants), CO and nicotine biomarkers, smoker preferences, perceptions of harm and puffing behaviors, and the subsequent range of toxicant exposures associated with these additives and behaviors. Study outcomes include waterpipe puffing behaviors, exhaled carbon monoxide levels, nicotine uptake, spirometry, sensory perceptions, smoking appeal, and risk perception. Waterpipe tobacco smoking is often the first combustible tobacco product tried by adolescents and young adults, possibly due to the widespread availability of heavily sweetened waterpipe tobacco and the perception that waterpipe smoking is a safer alternative to cigarette smoking. However, waterpipe tobacco smoking is associated with lung disease, carbon monoxide poisoning, and precursor conditions for oral and other cancers in adolescents and young adults. There is currently little data available on how the primary additives (by weight) in waterpipe tobacco affect puffing behaviors, toxicant exposures, pulmonary function and appeal. This clinical trial uses established waterpipe tobacco smokers, four investigational tobacco products with precisely manipulated levels of humectants and natural sugars in a single-blind, crossover (repeated measures) study design to determine how waterpipe tobacco additives effect human puffing behavior, nicotine uptake, flavor perceptions, lung function, and biomarkers of exposure.

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Key information

Conditions

Tobacco-Related Carcinoma

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

Currently there are no regulations governing the content of WP tobacco. Because mandated changes in tobacco content may lead to unintended consequences that ultimately result in public health declines, human use behaviors must be well understood prior to implementing regulatory product standards. The proposed study will include preparing and characterizing the content of 4 investigational tobacco products (ITPs) (Aim 1); characterizing the mainstream smoke toxicant emissions from machine smoking the 4 ITPs using a single, established puffing regimen (Aim 2); measuring human puffing behavior, general harm and specific health risk and flavor perceptions, lung function, and biomarkers of exposure in a group of established WP smokers smoking the 4 ITPs in the laboratory (Aim 3), and estimating toxicant exposure ranges using machine smoking and puffing regimens derived from the human laboratory testing (Aim 4).

The clinical trial (Aim 3) will focus on using a group of established adult and young adult WP smokers, a cross-over study design, CO and nicotine biomarkers, spirometry, cutting edge psychophysical measurement tools, and risk perception instruments to map the relationship between sensory experiences and preferences of sweetness and flavor to specific additive content in WP tobacco that affect these experiences, preferences, acute health effects, and toxicant exposures. Study subjects will participate in a series of 4 clinic sessions, each visit separated by at least a week, in which they smoke one of 4 tobacco preparations (single-blind) using a research grade waterpipe in a randomly assigned sequence in a smoking room with sufficiently controlled ventilation rate to keep ambient air CO levels below 25 ppm. Exhaled CO, whole blood samples and spirometry measures will be collected before and immediately after the smoking session. Taste perceptions, liking/disliking, and risk perceptions will be determined via questionnaires before, during, and after smoking.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sufficient understanding of consent form and study procedures
  • Age 21-50 years old
  • Experienced WP smokers defined as having smoked a WP at least 3 times per month in the last month
  • Willing/able to abstain from nicotine product use for at least 12 hours prior to the laboratory visits
  • Willing to attend four laboratory sessions at the same time of day lasting approximately 3 hours (h) each
  • Read and speak English

Exclusion criteria

  • Evident intoxication on any visit
  • Exhaled breath CO > 10 ppm
  • Pregnancy (known or suspected), trying to become pregnant, breastfeeding, unwillingness to use contraception for the duration of the study
  • Significant smoking-related disease (by history)
  • Any of the following in the past 30 days (self-report):
  • Uncontrolled asthma or asthma that is worse than usual
  • Severe respiratory allergies, such as wheezing, coughing, shortness of breath when exposed to known allergens
  • Acute upper or lower respiratory illnesses like the flu, common cold, or pneumonia
  • Any other serious lung infection or disease, such as tuberculosis, cystic fibrosis, or lung cancer
  • Hospitalization for difficulty breathing
  • Currently engaging in a WP tobacco smoking quit attempt

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies

Tobacco Smoking

Behavioral

Smoke waterpipe tobacco

Other names: Smoking, Tobacco, Smoking

Primary outcomes

  1. Change in Exhaled Breath Carbon Monoxide (CO)

    Time frame: Approximately 30 to 90 minutes

    Change from baseline exhaled breath carbon monoxide (boost). CO was collected before and immediately after each smoking session with a handheld electrochemical cell.

  2. Change in Plasma Nicotine

    Time frame: Approximately 30 to 90 minutes

    Change from baseline plasma nicotine (boost): Whole blood was collected before and immediately after each smoking session, separated, and plasma layer transferred and stored at -80 °C until analysis for nicotine according to validated methods using LC-MS/MS.

  3. Change in Forced Vital Capacity (FVC)

    Time frame: Approximately 30 to 90 minutes

    Spirometer measurements will be collected - change in forced vital capacity (FVC) (post-pre).

  4. Change in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Approximately 30 to 90 minutes

    Spirometer measurements will be collected - change in forced expiratory volume in 1 second (FEV1) (post-pre)

  5. Change in FEV1/FVC; The Ratio of the Forced Expiratory Volume in the First One Second to the Forced Vital Capacity of the Lungs.

    Time frame: Approximately 30 to 90 minutes

    Spirometer measurements will be collected - change in FEV1/FVC, the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs (post-pre).

  6. Change in Peak Expiratory Flow (PEF)

    Time frame: Approximately 30 to 90 minutes

    Spirometer measurements will be collected - change in peak expiratory flow (PEF) (post-pre).

  7. Change in Forced Expiratory Flow at 25-75% of FVC

    Time frame: Approximately 30 to 90 minutes

    Spirometer measurements will be collected - change in forced expiratory flow at 25-75% of FVC (post-pre).

  8. Tobacco Use History

    Time frame: Baseline

    Ever use of tobacco products, assessed at the first study visit

  9. Nicotine Dependence (HONC)

    Time frame: Baseline

    Hooked on Nicotine Checklist (HONC) comprised of 10 "Yes" or "No" questions, assessed on the first study visit. Scores range from 0 to 10 with higher scores indicating greater nicotine dependence.

  10. Nicotine Dependence (LWDS)

    Time frame: Baseline

    Lebanese Waterpipe Dependence Scale (LWDS) comprised of twelve questions and assessed on the first study visit. LWDS values range from 0 to 36 where higher sores indicate greater nicotine dependence.

  11. General Harm and Health Risk Perceptions

    Time frame: Post Smoking Session

    Assessed using harm/health risk perceptions questionnaire. General harm is rated after the smoking session on a scale from 0 (no harm) to 10 (extreme harm) with higher scores indicating a greater perceived harm/health risk.

  12. Subjective Effects of Smoking Tobacco

    Time frame: Post Smoking Session

    Direct Effects of Tobacco scale; the scale for each effect ranges from 0 (not at all) to 100 (extremely) with higher ratings indicating a greater effect of the tobacco.

  13. Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine

    Time frame: Approximately 30 to 90 minutes

    Change in Direct Effects of Nicotine scale from baseline (post - pre). The scale for each effect ranges from 0 (not at all) to 100 (extremely) with higher ratings indicating a greater effect of the tobacco.

  14. Change in Subjective Effects of Smoking Tobacco (QSU)

    Time frame: Approximately 30 to 90 minutes

    Change from baseline Questionnaire for Urges to Smoke (post - pre).

    This is a 10-item measure where participants rate smoking-related items on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). Items are collapsed into two previously identified factors (Factor 1: strong desire and intention to smoke; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 30 with higher scores indicating greater urge to smoke.

  15. Change in Nicotine Withdrawal Assessment (MNWS)

    Time frame: Approximately 30 to 90 minutes

    Change from baseline using Waterpipe-modified Minnesota Withdrawal Scale (post - pre).

    The scale ranges from 0 (not at all) to 100 (extremely) with higher total numbers meaning greater withdrawal symptoms.

  16. Tobacco Flavor Perception (gLMS)

    Time frame: Post Smoking Session

    To determine the relative intensity of specific flavors, e.g., sweetness, the general version of the Labeled Magnitude Scale (gLMS) was used post-smoking session. The scale ranges from 0 to 100 where higher scores indicate that the perception is stronger.

  17. Tobacco Flavors Perception, Degree of Liking or Disliking (LHS)

    Time frame: Post Smoking Session

    To assess the degree of liking or disliking of flavors, will use the Labeled Hedonic Scale (LHS) to collect ratio-level data on the magnitude of liking and disliking of sensation post-smoking session. Scores range from 0 to 100 with higher scores indicating greater liking.

  18. Puffing Topography - Puff Volume

    Time frame: Up to 60 minutes

    Puff volume measured continuously during the smoking session using the research-grade waterpipe.

  19. Puffing Topography - Puff Duration

    Time frame: Up to 60 minutes

    Puff duration measured continuously during the smoking session using the research-grade waterpipe.

  20. Puffing Topography - Flow Rate

    Time frame: Up to 60 minutes

    Puffing average flow rate measured continuously during the smoking session using the research-grade waterpipe.

  21. Puffing Topography - Peak Flow Rate

    Time frame: Up to 60 minutes

    Puffing peak flow rate measured continuously during the smoking session using the research-grade waterpipe.

  22. Puffing Topography - Interpuff Interval

    Time frame: Up to 60 minutes

    Interpuff interval measured continuously during the smoking session using the research-grade waterpipe.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Cancer Institute (NCI)
  • Ohio State University

Registry information

Official study title

Waterpipe Tobacco Additives and Their Effect on Human Puffing Behavior, Toxicant Exposures, Pulmonary Function, and Appeal

Acronym: HARPS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2022
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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