Hookah Additive Research to Inform Product Standards

NCT05453773 | Completed Results DMC

• 3 other identifiers: OSU-22158NCI-2022-05156R01CA255563
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (22)

• Change in Exhaled Breath Carbon Monoxide (CO)

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

  Approximately 30 to 90 minutes

• Change in Plasma Nicotine

  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.

  Approximately 30 to 90 minutes

• Change in Forced Vital Capacity (FVC)

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

  Approximately 30 to 90 minutes

• Change in Forced Expiratory Volume in 1 Second (FEV1)

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

  Approximately 30 to 90 minutes

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

  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).

  Approximately 30 to 90 minutes

• Change in Peak Expiratory Flow (PEF)

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

  Approximately 30 to 90 minutes

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

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

  Approximately 30 to 90 minutes

• Tobacco Use History

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

  Baseline

• Nicotine Dependence (HONC)

  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.

  Baseline

• Nicotine Dependence (LWDS)

  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.

  Baseline

• General Harm and Health Risk Perceptions

  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.

  Post Smoking Session

• Subjective Effects of Smoking Tobacco

  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.

  Post Smoking Session

• Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine

  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.

  Approximately 30 to 90 minutes

• Change in Subjective Effects of Smoking Tobacco (QSU)

  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.

  Approximately 30 to 90 minutes

• Change in Nicotine Withdrawal Assessment (MNWS)

  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.

  Approximately 30 to 90 minutes

• Tobacco Flavor Perception (gLMS)

  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.

  Post Smoking Session

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

  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.

  Post Smoking Session

• Puffing Topography - Puff Volume

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

  Up to 60 minutes

• Puffing Topography - Puff Duration

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

  Up to 60 minutes

• Puffing Topography - Flow Rate

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

  Up to 60 minutes

• Puffing Topography - Peak Flow Rate

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

  Up to 60 minutes

• Puffing Topography - Interpuff Interval

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

  Up to 60 minutes

Study Arms (4)

Tobacco flavor preparation; High Sweetness, High Humectant (tobacco smoking)

EXPERIMENTAL

Participants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered.

Other: Questionnaire Administration; Behavioral: Tobacco Smoking

Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking)

EXPERIMENTAL

Participants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered.

Other: Questionnaire Administration; Behavioral: Tobacco Smoking

Tobacco flavor preparation; Medium Sweetness, High Humectant (tobacco smoking)

EXPERIMENTAL

Participants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered.

Other: Questionnaire Administration; Behavioral: Tobacco Smoking

Tobacco flavor preparation; Medium Sweetness, Medium Humectant (tobacco smoking)

EXPERIMENTAL

Participants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered.

Other: Questionnaire Administration; Behavioral: Tobacco Smoking

Interventions

Questionnaire Administration OTHER

Ancillary studies

Tobacco flavor preparation; High Sweetness, High Humectant (tobacco smoking); Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking); Tobacco flavor preparation; Medium Sweetness, High Humectant (tobacco smoking); Tobacco flavor preparation; Medium Sweetness, Medium Humectant (tobacco smoking)

Tobacco Smoking BEHAVIORAL

Smoke waterpipe tobacco

Also known as: Smoking, Tobacco, Smoking

Tobacco flavor preparation; High Sweetness, High Humectant (tobacco smoking); Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking); Tobacco flavor preparation; Medium Sweetness, High Humectant (tobacco smoking); Tobacco flavor preparation; Medium Sweetness, Medium Humectant (tobacco smoking)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Ohio State University: collaborator
• National Cancer Institute (NCI): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Smoking Devices

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Marielle Brinkman
• Organization: Ohio State University Comprehensive Cancer Center

brinkman.224@osu.edu

614-688-3226

Study Officials

• Marielle C Brinkman

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 12, 2022
• Study Start: June 19, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)