Tobacco-Related CarcinomaHARPSNCT05453773
Hookah Additive Research to Inform Product Standards
A study testing Questionnaire Administration and Tobacco Smoking in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco-Related Carcinoma
- What is being tested?
- Questionnaire Administration and Tobacco Smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2022to 11 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Waterpipe Tobacco Additives and Their Effect on Human Puffing Behavior, Toxicant Exposures, Pulmonary Function, and Appeal
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.
Read the detailed description
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.
- Conditions
- Tobacco-Related Carcinoma
- Being tested
- Questionnaire Administration, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
Tobacco SmokingBehavioural
Also called Smoking, Tobacco, Smoking
Smoke waterpipe tobacco
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Questionnaire Administration; Behavioral: Tobacco Smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 30 to 90 minutes
Change in Forced Vital Capacity (FVC)
Spirometer measurements will be collected - change in forced vital capacity (FVC) (post-pre).
Measured: 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)
Measured: 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).
Measured: Approximately 30 to 90 minutes
Change in Peak Expiratory Flow (PEF)
Spirometer measurements will be collected - change in peak expiratory flow (PEF) (post-pre).
Measured: 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).
Measured: Approximately 30 to 90 minutes
Tobacco Use History
Ever use of tobacco products, assessed at the first study visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post Smoking Session
Puffing Topography - Puff Volume
Puff volume measured continuously during the smoking session using the research-grade waterpipe.
Measured: Up to 60 minutes
Puffing Topography - Puff Duration
Puff duration measured continuously during the smoking session using the research-grade waterpipe.
Measured: Up to 60 minutes
Puffing Topography - Flow Rate
Puffing average flow rate measured continuously during the smoking session using the research-grade waterpipe.
Measured: Up to 60 minutes
Puffing Topography - Peak Flow Rate
Puffing peak flow rate measured continuously during the smoking session using the research-grade waterpipe.
Measured: Up to 60 minutes
Puffing Topography - Interpuff Interval
Interpuff interval measured continuously during the smoking session using the research-grade waterpipe.
Measured: Up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start19 Jun 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, National Cancer Institute (NCI), Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Marielle Brinkman, Ohio State University Comprehensive Cancer Center
- Investigators
- Marielle C Brinkman, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453773
- Sponsor's protocol ID
- OSU-22158
- Other IDs
- NCI-2022-05156, R01CA255563
- Acronym
- HARPS
- Status last verified
- Dec 2024
- First submitted
- 1 Jul 2022
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waterpipe Tobacco Additives and Their Effect on Human Puffing Behavior, Toxicant Exposures, Pulmonary Function, and Appeal
- ClinicalTrials.gov ID
- NCT05453773
- Acronym / sponsor ID
- HARPS / OSU-22158
- Conditions
- Tobacco-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Ohio State University, National Cancer Institute (NCI), Food and Drug Administration (FDA)
- Study start
- 19 Jun 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Posted 31 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tobacco flavor preparation; High Sweetness, High Humectant (tobacco smoking) | Experimental | Other: Questionnaire Administration, Behavioral: Tobacco SmokingParticipants 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; High Sweetness, Medium Humectant (tobacco smoking) | Experimental | Other: Questionnaire Administration, Behavioral: Tobacco SmokingParticipants 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 | Other: Questionnaire Administration, Behavioral: Tobacco SmokingParticipants 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, Medium Humectant (tobacco smoking) | Experimental | Other: Questionnaire Administration, Behavioral: Tobacco SmokingParticipants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationAncillary studies | Other | 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 SmokingAlso: Smoking, Tobacco, SmokingSmoke waterpipe tobacco | Behavioural | 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) |
Primary outcome
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.
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.
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).
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)
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).
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).
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).
Tobacco Use History
Time frame: Baseline
Ever use of tobacco products, assessed at the first study visit
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.
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.
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.
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.
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.
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.
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.
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.
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.
Puffing Topography - Puff Volume
Time frame: Up to 60 minutes
Puff volume measured continuously during the smoking session using the research-grade waterpipe.
Puffing Topography - Puff Duration
Time frame: Up to 60 minutes
Puff duration measured continuously during the smoking session using the research-grade waterpipe.
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.
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.
Puffing Topography - Interpuff Interval
Time frame: Up to 60 minutes
Interpuff interval measured continuously during the smoking session using the research-grade waterpipe.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle C Brinkman principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Tobacco Smoking in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exhaled Breath Carbon Monoxide (CO) (time frame: Approximately 30 to 90 minutes). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.