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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05156 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01CA255563 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
| National Cancer Institute (NCI) | NIH |
| Food and Drug Administration (FDA) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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):
Currently engaging in a WP tobacco smoking quit attempt
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| Name | Affiliation | Role |
|---|---|---|
| Marielle C Brinkman | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Population | Full population of participants participating in the randomized crossover trial. Over a series of four laboratory sessions each participant received all four treatments in a randomized order, one treatment per session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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3 participants were unable to complete any study visits due to difficult blood draws; these participants are excluded here
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Population | Population of randomized participants who fully completed at least one study visit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | ppm | Approximately 30 to 90 minutes |
|
Approximately 1 Month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Humectant, High Sweetness | Tobacco Preparation: High Humectant, High Sweetness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marielle Brinkman | Ohio State University Comprehensive Cancer Center | 614-688-3226 | brinkman.224@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 3, 2021 | Feb 27, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Tobacco Smoking | Behavioral | Smoke waterpipe tobacco |
|
|
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Age when first tried Waterpipe | Mean | Standard Deviation | years |
|
Tobacco Preparation: Medium Humectant, High Sweetness |
| OG003 | Medium Humectant, Medium Sweetness | Tobacco Preparation: Medium Humectant, Medium Sweetness |
|
|
| Primary | 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. | Participants who attended their study visit and were able to provide a plasma sample | Posted | Mean | Standard Deviation | ng/mL | Approximately 30 to 90 minutes |
|
|
|
| Primary | Change in Forced Vital Capacity (FVC) | Spirometer measurements will be collected - change in forced vital capacity (FVC) (post-pre). | Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit. | Posted | Mean | Standard Deviation | Liters | Approximately 30 to 90 minutes |
|
|
|
| Primary | 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) | Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit. | Posted | Mean | Standard Deviation | Liters | Approximately 30 to 90 minutes |
|
|
|
| Primary | 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). | Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit. | Posted | Mean | Standard Deviation | ratio | Approximately 30 to 90 minutes |
|
|
|
| Primary | Change in Peak Expiratory Flow (PEF) | Spirometer measurements will be collected - change in peak expiratory flow (PEF) (post-pre). | Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit. | Posted | Mean | Standard Deviation | Liters / second | Approximately 30 to 90 minutes |
|
|
|
| Primary | 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). | Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit. | Posted | Mean | Standard Deviation | L/s | Approximately 30 to 90 minutes |
|
|
|
| Primary | Tobacco Use History | Ever use of tobacco products, assessed at the first study visit | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Post Smoking Session |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Post Smoking Session |
|
|
|
| Primary | 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. | Data is missing for 1 participant from the High Humectant, High Sweetness and Medium Humectant, Medium Sweetness arms as they declined to respond to the pre-smoking survey items. | Posted | Mean | Standard Deviation | score on a scale | Approximately 30 to 90 minutes |
|
|
|
| Primary | 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. | 1 participant in the high humectant, medium sweetness arm and 1 participant in the medium humectant, medium sweetness arm declined to provide responses post-smoking. | Posted | Mean | Standard Deviation | score on a scale | Approximately 30 to 90 minutes |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Approximately 30 to 90 minutes |
|
|
|
| Primary | 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. | One participant declined to provide a response during their the high humectant, high sweetness study visit | Posted | Mean | Standard Deviation | score on a scale | Post Smoking Session |
|
|
|
| Primary | 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. | One participant declined to provide a response during their the high humectant, high sweetness study visit | Posted | Mean | Standard Deviation | score on a scale | Post Smoking Session |
|
|
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| Primary | Puffing Topography - Puff Volume | Puff volume measured continuously during the smoking session using the research-grade waterpipe. | Posted | Mean | Standard Deviation | Liters | Up to 60 minutes | Puffs | Puffs |
|
|
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| Primary | Puffing Topography - Puff Duration | Puff duration measured continuously during the smoking session using the research-grade waterpipe. | Posted | Mean | Standard Deviation | seconds | Up to 60 minutes | Puffs | Puffs |
|
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| Primary | Puffing Topography - Flow Rate | Puffing average flow rate measured continuously during the smoking session using the research-grade waterpipe. | Posted | Mean | Standard Deviation | Liters / Minute | Up to 60 minutes | Puffs | Puffs |
|
|
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| Primary | Puffing Topography - Peak Flow Rate | Puffing peak flow rate measured continuously during the smoking session using the research-grade waterpipe. | Posted | Mean | Standard Deviation | Liters / Minute | Up to 60 minutes | Puffs | Puffs |
|
|
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| Primary | Puffing Topography - Interpuff Interval | Interpuff interval measured continuously during the smoking session using the research-grade waterpipe. | Posted | Mean | Standard Deviation | seconds | Up to 60 minutes | Puffs | Puffs |
|
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | High Humectant, Medium Sweetness | Tobacco Preparation: High Humectant, Medium Sweetness | 0 | 46 | 0 | 46 | 0 | 46 |
| EG002 | Medium Humectant, High Sweetness | Tobacco Preparation: Medium Humectant, High Sweetness | 0 | 46 | 0 | 46 | 0 | 46 |
| EG003 | Medium Humectant, Medium Sweetness | Tobacco Preparation: Medium Humectant, Medium Sweetness | 0 | 48 | 0 | 48 | 0 | 48 |
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| Pleasant |
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| Taste Good |
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| Taste Bad |
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| Make you Dizzy |
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| Calm you Down |
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| Feel Confused |
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| Help you Concentrate |
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| Feel More Awake |
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| Reduce Hunger |
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| Make you Sick |
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| Make you Sleepy |
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| Like to smoke another hookah right now |
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| Dizzy |
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| Lightheaded |
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| Nervous |
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| Sweaty |
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| Headache |
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| Excessive Salivation |
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| Heart Pounding |
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| Confused |
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| Weak |
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| Relief |
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| Irritability/Frustration/Anger |
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| Anxious |
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| Difficulty Concentrating |
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| Restlessness |
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| Hunger |
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| Impatient |
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| Craving a Waterpipe/Nicotine |
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| Drowsiness |
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| Depression/Feeling Blue |
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| Desire for Sweets |
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| Bitterness |
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| Smoothness |
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| Harshness |
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| Coolness |
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