Waterpipe SmokingNCT03589599
Understanding the Effect of Flavor on Hookah Smoking Experience
A study testing Flavored tobacco and Non-flavored tobacco in people with Waterpipe Smoking, run by Florida International University at 1 site in United States.
Trial summary
This project addresses the need for evidence about the effect of flavoring manipulation on waterpipe smokers' satisfaction, dependence, harm perception, and toxicants exposure. Specifically, in this clinical study investigators will compare the effect on flavored and non-flavored waterpipe tobacco on smoking behavior… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Waterpipe Smoking
- What is being tested?
- Flavored tobacco and Non-flavored tobacco
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy individuals (determined by physical examination).
- Age of 18-30 years.
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
- WP smokers who smoke flavored WP tobacco.
- Have abstained from WP for 12 hours prior to each session
Who cannot join
- Report smoking cigarettes regularly (> 5 cigarettes/month in the past year).
- Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year.
- Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
- Individuals with self-reported history of chronic disease or psychiatric conditions.
- Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Understanding Tobacco Flavor Effects on Waterpipe Smokers' Experiences and Exposures
This project addresses the need for evidence about the effect of flavoring manipulation on waterpipe smokers' satisfaction, dependence, harm perception, and toxicants exposure. Specifically, in this clinical study investigators will compare the effect on flavored and non-flavored waterpipe tobacco on smoking behavior, subjective experiences and toxicant exposure among waterpipe users. Findings from this study will help informing flavor-based product regulation by the FDA.
Read the detailed description
Waterpipe (WP) tobacco smoking (a.k.a. hookah, shisha, narghile) is increasing rapidly in the United States (US), particularly among young people. Evidence suggests that WP smoking can lead to dependence, other tobacco use, and many of the known smoking-related diseases including cancer, cardiovascular disease and adverse pregnancy outcomes. These alarming trends led the Food and Drug Administration (FDA) in 2014 to propose including the WP under its regulatory authority, allowing the FDA to apply evidence-based regulatory approaches to control WP spread in the US. Given the salience of flavored tobacco in shaping the "WP experience", regulating WP tobacco flavor represents a promising approach for the FDA to curb WP use among US youth. This project aims to assist the FDA in these efforts by providing answers to specific questions pertinent to the potential of WP regulation through flavor. These include: - How would flavor manipulation affect the smoking experience and satisfaction of WP users at different stages of their smoking trajectory - How would smoking non-preferred flavor or unflavored WP tobacco reflects on smokers' exposure to nicotine, and dependence; and - How would flavor manipulation influence puffing behavior and exposure to toxicants such as carbon monoxide (CO) among WP smokers. Answers to these questions will help the FDA predict the impact of flavor regulation on WP experimentation and continued use. In this study, investigators will use clinical laboratory methods to answer these questions. Two groups of WP smokers will be recruited based on their use frequency: low (Beginners) vs. high frequency (Experienced) smokers (72/group; total 144; age 18-30). Each participant will undergo 2 WP smoking sessions that differ by flavor (preferred flavor; unflavored), while measurement of WP satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted. The response of WP smokers at different stages of their WP smoking trajectory (Beginners vs. Experienced) to flavor manipulation, will allow to predict the effect of limiting flavors on a wide range of WP smokers. This project promises to provide the first evidence to guide the FDA in terms of the potential of regulating WP flavored tobacco on WP uptake and use in the US.
- Conditions
- Waterpipe Smoking
- Being tested
- Flavored tobacco, Non-flavored tobacco
- Medical subject headings
- Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavored tobaccoOther
Effects of flavored tobacco
Non-flavored tobaccoOther
Effects of non-flavored tobacco
| Study group | Role | What they receive |
|---|---|---|
| Flavored tobacco | Experimental | All participants will be completing a lab visit where they smoke flavored waterpipe tobacco ad lib for up to 45 min. Receives: Other: Flavored tobacco |
| Non-flavored tobacco | Experimental | All participants will be completing a lab visit where they smoke non-flavored waterpipe tobacco ad lib for up to 45 min. Receives: Other: Non-flavored tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nicotine
Change in plasma nicotine level
Measured: During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period
Secondary outcomes (7)
Puff topography
measurement of puffing behavior
Measured: During participants' 1st and 2nd visit. Puffing behavior is continuously measured during each smoking session (an approximately 45-min ad lib use period)
Minnesota Nicotine Withdrawal Scale
This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100. These items are presented as Visual Analog Scale with item (measure) centered above a horizontal line anchored on the left with not at all and on the right with extremely.
Measured: During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
Tiffany-Drobes Questionnaire of Smoking Urges
This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 10 items that are scored 0 - 7. Rated on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Measured: During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
Carbon monoxide levels
Change in carbon monoxide levels (in parts per mission)
Measured: During participants' 1st and 2nd visit. Carbon monoxide levels will be measured 2 times in each smoking session:before and after an approximately 45-min ad lib use period
Harm perception
This scale assess waterpipe harm perception and measure perceptions of waterpipe relative risk compared to cigarettes. The scale will be scored on a 7-point scale ranging from 1 (not at all harmful), to 7 (extremely harmful).
Measured: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
Duke Sensory Questionnaire
This scale assess participants sensory experience of the inhaled product. The scale has nine items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
Measured: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
The Cigarette/WP Evaluation Scale (WES)
This scale assesses participants' perception of the smoked waterpipe, The scale has 11 items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
Measured: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start21 Mar 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waterpipe SmokingStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wasim Maziak, phd, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589599
- Sponsor's protocol ID
- R01DA042477
- Status last verified
- Jul 2020
- First submitted
- 11 Jun 2018
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Tobacco Flavor Effects on Waterpipe Smokers' Experiences and Exposures
- ClinicalTrials.gov ID
- NCT03589599
- Acronym / sponsor ID
- R01DA042477
- Conditions
- Waterpipe Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project addresses the need for evidence about the effect of flavoring manipulation on waterpipe smokers' satisfaction, dependence, harm perception, and toxicants exposure. Specifically, in this clinical study investigators will compare the effect on flavored and non-flavored waterpipe tobacco on smoking behavior, subjective experiences and toxicant exposure among waterpipe users. Findings from this study will help informing flavor-based product regulation by the FDA.
Detailed description
Waterpipe (WP) tobacco smoking (a.k.a. hookah, shisha, narghile) is increasing rapidly in the United States (US), particularly among young people. Evidence suggests that WP smoking can lead to dependence, other tobacco use, and many of the known smoking-related diseases including cancer, cardiovascular disease and adverse pregnancy outcomes. These alarming trends led the Food and Drug Administration (FDA) in 2014 to propose including the WP under its regulatory authority, allowing the FDA to apply evidence-based regulatory approaches to control WP spread in the US. Given the salience of flavored tobacco in shaping the "WP experience", regulating WP tobacco flavor represents a promising approach for the FDA to curb WP use among US youth. This project aims to assist the FDA in these efforts by providing answers to specific questions pertinent to the potential of WP regulation through flavor. These include: - How would flavor manipulation affect the smoking experience and satisfaction of WP users at different stages of their smoking trajectory - How would smoking non-preferred flavor or unflavored WP tobacco reflects on smokers' exposure to nicotine, and dependence; and - How would flavor manipulation influence puffing behavior and exposure to toxicants such as carbon monoxide (CO) among WP smokers. Answers to these questions will help the FDA predict the impact of flavor regulation on WP experimentation and continued use. In this study, investigators will use clinical laboratory methods to answer these questions. Two groups of WP smokers will be recruited based on their use frequency: low (Beginners) vs. high frequency (Experienced) smokers (72/group; total 144; age 18-30). Each participant will undergo 2 WP smoking sessions that differ by flavor (preferred flavor; unflavored), while measurement of WP satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted. The response of WP smokers at different stages of their WP smoking trajectory (Beginners vs. Experienced) to flavor manipulation, will allow to predict the effect of limiting flavors on a wide range of WP smokers. This project promises to provide the first evidence to guide the FDA in terms of the potential of regulating WP flavored tobacco on WP uptake and use in the US.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavored tobacco | Experimental | Other: Flavored tobaccoAll participants will be completing a lab visit where they smoke flavored waterpipe tobacco ad lib for up to 45 min. |
| Non-flavored tobacco | Experimental | Other: Non-flavored tobaccoAll participants will be completing a lab visit where they smoke non-flavored waterpipe tobacco ad lib for up to 45 min. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Generally healthy individuals (determined by physical examination).
- Age of 18-30 years.
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
- WP smokers who smoke flavored WP tobacco.
Key exclusion criteria (5 listed)
- Report smoking cigarettes regularly (> 5 cigarettes/month in the past year).
- Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year.
- Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
- Individuals with self-reported history of chronic disease or psychiatric conditions.
- Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).
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 |
|---|---|---|
| Flavored tobaccoEffects of flavored tobacco | Other | Flavored tobacco |
| Non-flavored tobaccoEffects of non-flavored tobacco | Other | Non-flavored tobacco |
Primary outcome
Plasma nicotine
Time frame: During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period
Change in plasma nicotine level
7 secondary outcomes
Puff topography
Time frame: During participants' 1st and 2nd visit. Puffing behavior is continuously measured during each smoking session (an approximately 45-min ad lib use period)
Minnesota Nicotine Withdrawal Scale
Time frame: During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
Tiffany-Drobes Questionnaire of Smoking Urges
Time frame: During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
Carbon monoxide levels
Time frame: During participants' 1st and 2nd visit. Carbon monoxide levels will be measured 2 times in each smoking session:before and after an approximately 45-min ad lib use period
Harm perception
Time frame: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
Duke Sensory Questionnaire
Time frame: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
The Cigarette/WP Evaluation Scale (WES)
Time frame: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavored tobacco and Non-flavored tobacco in people with Waterpipe Smoking, run by Florida International University 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 5 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 3 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma nicotine (time frame: During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period). 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 3 Aug 2020.