Waterpipe SmokingNCT05317663
Developing and Testing Waterpipe-specific Health Warning Labels
A study testing Test Health Warning Label (HWL) and Test without Health Warning Label (no-HWL) in people with Waterpipe Smoking and Health Warning Label, run by Florida International University at 1 site in United States.
Trial summary
Waterpipe (WP) smoking has become one of the leading tobacco use methods among youth in Florida. The impact of this dramatic rise is amplified by the mounting evidence of WP addictive and harmful nature, as well as the lag of policy response to it. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Waterpipe Smoking, Health Warning Label, Harm Perception
- What is being tested?
- Test Health Warning Label (HWL) and Test without Health Warning Label (no-HWL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 9 Dec 2024
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 21-35 years.
- Beginners WP smokers (defined as started WP smoking in the past 6 months, but smoke WP less than weekly); or established WP smokers (defined as smoked at least once a week in the past 6 months).
- Generally healthy individuals (determined by physical examination).
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
- Have abstained from WP for 12 hours prior to each lab session.
Who cannot join
- 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).
- Report tobacco product use regularly (> 5 times/month in the past year).
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Developing and Testing Waterpipe-specific Health Warning Labels Targeting Young People in Florida
Waterpipe (WP) smoking has become one of the leading tobacco use methods among youth in Florida. The impact of this dramatic rise is amplified by the mounting evidence of WP addictive and harmful nature, as well as the lag of policy response to it. Evidence suggests WP use leads to nicotine addiction, and increases the risk of lung cancer, heart and respiratory disease and exposure to secondhand smoke. The spread of WP use among youth has been fueled by a misperception of reduced-harm compared to cigarettes. Health Warning Labels (HWLs) represent one of the most successful tobacco control strategies to communicate smoking- related risks, and studies have consistently shown that HWLs are associated with a decrease in smoking rates and smoking-related morbidity and mortality. Therefore, communicating WP risks to young people through HWLs has been identified as a priority by major health bodies in the US including the FDA.
Using the Delphi method among international tobacco control experts, our team has developed a set of 12 WP HWLs corresponding to 4 health themes; health risks/addiction, harm to others, WP-specific harm, WP harm compared to cigarettes. Building on this work, and using a mixed- method approach incorporating qualitative and quantitative research, the investigators propose to:
Read more
Aim 1: Adapt the 12 HWLs to young WP smokers in Florida using exploratory focus groups.
Aim 2: Test in a clinical lab experiment the performance of the top 4 HWLs on the WP device compared to no-HWL/control on harm perception, intention to quit, and toxicant exposure (Carbon monoxide (CO), nicotine, oxidative stress).
Aim 3: Use the knowledge obtained to advocate for the adoption of WP-HWLs policies and disseminate information about WP harmful effects to young people in Florida and nationally.
Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in Florida. This pioneering work will inform the FDA and public health advocates on the potential of WP-HWLs policies and provide a model for other states to respond to the WP epidemic.
Read the detailed description
Our Team developed 12 pictorial Health Warning Labels (HWLs) for the waterpipe (WP) corresponding to 4 themes; health risks/addiction, harm to others, specific harm, and harm compared to cigarettes. The investigators will build on this work to advance HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally through the following specific aims:
- Adapt the HWLs to young adults in Florida using focus groups. The investigators will conduct mixed- gender focus groups combined with brief survey with regular WP smokers (6-8 groups; n ≈ 65; age 18-29 yrs) to 1- adapt the 12 HWLs to our target population, 2- explore their optimal placement and size, and 3- select the top 4 HWLs for testing (Aim 2).
- Test the top 4 HWLs in a clinical lab experiment. Using the top 4 HWLs on the device, the investigators will recruit 2 groups of WP smokers (n= 248; age 18-29 yrs) based on their use frequency (beginners, established) for a within- (HWL vs no-HWL; pre- vs post- smoking) and between-subject (beginner vs. established; 4 HWLs) experiment. Participants will be randomly assigned to one of the 4 HWLs conditions and undergo 2 smoking sessions that differ by HWL (HWL vs. no-HWL), with pre-post smoking assessment of harm perception, intention to quit, and toxicant exposure. Participants will receive a follow-up phone call 3- month after exposure to assess longer-term changes in quit attitude and behavior. The investigators hypothesize that applying pictorial HWLs to the WP device will; 1- significantly increase harm perception and intention to quit, and reduce puffing behavior, satisfaction, and exposure to toxicants compared to no-HWL; 2- this effect will be more pronounced in beginner than established smokers.
- Disseminate knowledge. The investigators will partner with Tobacco-Free Workgroup, and Truth Initiative to advocate for the adoption of HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally.
Impact: Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in the US.
- Conditions
- Waterpipe Smoking, Health Warning Label, Harm Perception, Puffing Behaviour, Quitting Smoking, Health Risk Behaviors
- Being tested
- Test Health Warning Label (HWL), Test without Health Warning Label (no-HWL)
- Keywords
- waterpipe, Health warning label, Young people
- Medical subject headings
- Water Pipe Smoking, Smoking Cessation, Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Health Warning Label (HWL)Behavioural
Effect of Health Warning Label (HWL)
Test without Health Warning Label (no-HWL)Behavioural
Effect of no Health Warning Label (no-HWL)
| Study group | Role | What they receive |
|---|---|---|
| Waterpipe with Health Warning Label (HWL) | Experimental | All participants will complete a lab visit where they will smoke waterpipe with HWL for up to 45 minutes. Receives: Behavioral: Test Health Warning Label (HWL) |
| Absence of Waterpipe without Health Warning Label (HWL) | Experimental | All participants will complete a lab visit where they will smoke waterpipe without HWL for up to 45 minutes. Receives: Behavioral: Test without Health Warning Label (no-HWL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention and motivation to quit
Intention and motivation to quit will be measured by using 3 items; "Does the participant intend to reduce WP smoking?"; "Does the participant intend to quit WP smoking?", and "How motivated is the participant to quit WP smoking in the next month?" The scale will be scored on a 5-point scale ranging from 1 (not at all), to 5 (very much).
Measured: pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.
Secondary outcomes (13)
Harm perception
Harm perception will be measured by using 1 item "To what extent does the participant think about the serious health effects of WP smoking?". This scale will assess WP harm perception and measure perceptions of WP 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: pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.
Exhaled Breath Condensate (EBC)
To test for markers of oxidative stress and DNA damage. The investigators will test for 6 biomarkers (8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxoguanosine, 8-isoprostane, formaldehyde, acetaldehyde and malondialdehyde). Samples will be collected during 15 min of tidal breathing through a single-use disposable Respiratory Tube Tympanic Membrane collector (Respiratory Research, Inc., Charlottesville, Va., USA). After sample collection, a plunger will be used to pool the condensed material within the tube into a single sample (about 1.0-2 ml). EBC samples will be divided in aliquots and stored at -80°C. EBC samples will be analyzed by our Forensic Chemistry Lab at Florida International University using Online Solid-Phase Extraction and Liquid Chromatography Triple Quadrupole Mass Spectrometry and Gas Chromatography Mass Spectrometry.
Measured: It will be collected pre-post smoking session. Each session is approximately 45 minutes ad lib use period.
Social interaction
Social interaction will be measured by using 1 item "Since the participant started the study, how many times did the participant have a conversations with the family/friends about the HWLs?"
Measured: at 3-month assessment
Change in WP smoking
Change in WP smoking will be measured by using 3 items; "Since the participant started the study, 1- did the participant stop smoking for 1 day or longer because the participant was trying to quit WP smoking?, 2- did the participant avoid smoking WP because the participant was thinking about the HWLs?, and 3- did the participant stop WP smoking completely because of the HWLs?"
Measured: at 3-month assessment
Toxicant exposure: expired carbon monoxide
expired carbon monoxide will be measured via expired carbon monoxide monitor.
Measured: initially at the beginning of the smoking session (abstinence verification), and within 10 minutes after the WP smoking session
Puff topography
Measurement of puffing behavior.
Measured: continuously during smoking. Puffing behavior is continuously measured during each WP smoking session (an approximately 45 minutes ad lib use period)
Hear rate
Change in heart rate, measured in beats per minute.
Measured: continuously during smoking. Each session is approximately 45 minutes ad lib use period.
Blood pressure
Change in blood pressure, measured in mm/hg.
Measured: continuously during smoking. Each session is approximately 45 minutes ad lib use period.
Duke Sensory Questionnaire (DSQ)
This scale will 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: DSQ will be measured only after smoking. The session is approximately 45 minutes ad lib use period.
The Cigarette/WP Evaluation Scale (WES)
This scale assesses participants' perception of WP smoking. 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: WES will be measured only after smoking. The session is approximately 45 minutes 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.
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
Lung function tests (LFTs)
LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after hookah smoking. According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., % predicted value pred (FVC), FEV1 % pred FEV1/FVC, % pred); forced expiratory flow (FEF) and peak expiratory flow rate or (PEFR) will be performed. Diffusing capacity for carbon monoxide (DLCO) will be determined using a rapidly resolving gas analyzer (RGA) and the single-breath technique. Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
Measured: During participants' 2 study visits. Lung function tests will be measured 2 times in each hookah smoking session: before and after an approximately 45 minutes 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 posted8 Apr 2022
- Study start3 Oct 2022
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will conduct a 2x2x2x4 within-subject (2: HWL vs no-HWL x 2: pre- vs post- smoking) and between-subject (2: beginner vs established smokers x 4: HWLs) experimental study. Participant in each group (beginner, established smoker) will be randomly assigned to one of the 4 HWLs conditions, and undergo 2 WP smoking sessions that differ by HWL on the WP device (HWL vs. no-HWL), with pre-/post-smoking assessment of harm perception, intention to quit, puffing behavior, satisfaction, urge to smoke, and toxicant exposure. The investigators will use Latin Square crossover design balanced for carry-over effect (random order of 4 HWL condition), and to ensure equal distribution of study participants across gender.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317663
- Sponsor's protocol ID
- 20B16
- Status last verified
- Dec 2024
- First submitted
- 28 Feb 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing Waterpipe-specific Health Warning Labels Targeting Young People in Florida
- ClinicalTrials.gov ID
- NCT05317663
- Acronym / sponsor ID
- 20B16
- Conditions
- Waterpipe Smoking, Health Warning Label, Harm Perception, Puffing Behaviour, Quitting Smoking, Health Risk Behaviors
- Keywords
- waterpipe, Health warning label, Young people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 8 Apr 2022 (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.
Waterpipe (WP) smoking has become one of the leading tobacco use methods among youth in Florida. The impact of this dramatic rise is amplified by the mounting evidence of WP addictive and harmful nature, as well as the lag of policy response to it. Evidence suggests WP use leads to nicotine addiction, and increases the risk of lung cancer, heart and respiratory disease and exposure to secondhand smoke. The spread of WP use among youth has been fueled by a misperception of reduced-harm compared to cigarettes. Health Warning Labels (HWLs) represent one of the most successful tobacco control strategies to communicate smoking- related risks, and studies have consistently shown that HWLs are associated with a decrease in smoking rates and smoking-related morbidity and mortality. Therefore, communicating WP risks to young people through HWLs has been identified as a priority by major health bodies in the US including the FDA.
Using the Delphi method among international tobacco control experts, our team has developed a set of 12 WP HWLs corresponding to 4 health themes; health risks/addiction, harm to others, WP-specific harm, WP harm compared to cigarettes. Building on this work, and using a mixed- method approach incorporating qualitative and quantitative research, the investigators propose to:
Aim 1: Adapt the 12 HWLs to young WP smokers in Florida using exploratory focus groups.
Aim 2: Test in a clinical lab experiment the performance of the top 4 HWLs on the WP device compared to no-HWL/control on harm perception, intention to quit, and toxicant exposure (Carbon monoxide (CO), nicotine, oxidative stress).
Aim 3: Use the knowledge obtained to advocate for the adoption of WP-HWLs policies and disseminate information about WP harmful effects to young people in Florida and nationally.
Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in Florida. This pioneering work will inform the FDA and public health advocates on the potential of WP-HWLs policies and provide a model for other states to respond to the WP epidemic.
Detailed description
Our Team developed 12 pictorial Health Warning Labels (HWLs) for the waterpipe (WP) corresponding to 4 themes; health risks/addiction, harm to others, specific harm, and harm compared to cigarettes. The investigators will build on this work to advance HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally through the following specific aims:
- Adapt the HWLs to young adults in Florida using focus groups. The investigators will conduct mixed- gender focus groups combined with brief survey with regular WP smokers (6-8 groups; n ≈ 65; age 18-29 yrs) to 1- adapt the 12 HWLs to our target population, 2- explore their optimal placement and size, and 3- select the top 4 HWLs for testing (Aim 2).
- Test the top 4 HWLs in a clinical lab experiment. Using the top 4 HWLs on the device, the investigators will recruit 2 groups of WP smokers (n= 248; age 18-29 yrs) based on their use frequency (beginners, established) for a within- (HWL vs no-HWL; pre- vs post- smoking) and between-subject (beginner vs. established; 4 HWLs) experiment. Participants will be randomly assigned to one of the 4 HWLs conditions and undergo 2 smoking sessions that differ by HWL (HWL vs. no-HWL), with pre-post smoking assessment of harm perception, intention to quit, and toxicant exposure. Participants will receive a follow-up phone call 3- month after exposure to assess longer-term changes in quit attitude and behavior. The investigators hypothesize that applying pictorial HWLs to the WP device will; 1- significantly increase harm perception and intention to quit, and reduce puffing behavior, satisfaction, and exposure to toxicants compared to no-HWL; 2- this effect will be more pronounced in beginner than established smokers.
- Disseminate knowledge. The investigators will partner with Tobacco-Free Workgroup, and Truth Initiative to advocate for the adoption of HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally.
Impact: Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will conduct a 2x2x2x4 within-subject (2: HWL vs no-HWL x 2: pre- vs post- smoking) and between-subject (2: beginner vs established smokers x 4: HWLs) experimental study. Participant in each group (beginner, established smoker) will be randomly assigned to one of the 4 HWLs conditions, and undergo 2 WP smoking sessions that differ by HWL on the WP device (HWL vs. no-HWL), with pre-/post-smoking assessment of harm perception, intention to quit, puffing behavior, satisfaction, urge to smoke, and toxicant exposure. The investigators will use Latin Square crossover design balanced for carry-over effect (random order of 4 HWL condition), and to ensure equal distribution of study participants across gender.
| Arm | Type | Receives |
|---|---|---|
| Waterpipe with Health Warning Label (HWL) | Experimental | Behavioral: Test Health Warning Label (HWL)All participants will complete a lab visit where they will smoke waterpipe with HWL for up to 45 minutes. |
| Absence of Waterpipe without Health Warning Label (HWL) | Experimental | Behavioral: Test without Health Warning Label (no-HWL)All participants will complete a lab visit where they will smoke waterpipe without HWL for up to 45 minutes. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age of 21-35 years.
- Beginners WP smokers (defined as started WP smoking in the past 6 months, but smoke WP less than weekly); or established WP smokers (defined as smoked at least once a week in the past 6 months).
- Generally healthy individuals (determined by physical examination).
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
Key exclusion criteria (4 listed)
- 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).
- Report tobacco product use regularly (> 5 times/month in the past year).
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 |
|---|---|---|
| Test Health Warning Label (HWL)Effect of Health Warning Label (HWL) | Behavioural | Waterpipe with Health Warning Label (HWL) |
| Test without Health Warning Label (no-HWL)Effect of no Health Warning Label (no-HWL) | Behavioural | Absence of Waterpipe without Health Warning Label (HWL) |
Primary outcome
Intention and motivation to quit
Time frame: pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.
Intention and motivation to quit will be measured by using 3 items; "Does the participant intend to reduce WP smoking?"; "Does the participant intend to quit WP smoking?", and "How motivated is the participant to quit WP smoking in the next month?" The scale will be scored on a 5-point scale ranging from 1 (not at all), to 5 (very much).
13 secondary outcomes
Harm perception
Time frame: pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.
Exhaled Breath Condensate (EBC)
Time frame: It will be collected pre-post smoking session. Each session is approximately 45 minutes ad lib use period.
Social interaction
Time frame: at 3-month assessment
Change in WP smoking
Time frame: at 3-month assessment
Toxicant exposure: expired carbon monoxide
Time frame: initially at the beginning of the smoking session (abstinence verification), and within 10 minutes after the WP smoking session
Puff topography
Time frame: continuously during smoking. Puffing behavior is continuously measured during each WP smoking session (an approximately 45 minutes ad lib use period)
Hear rate
Time frame: continuously during smoking. Each session is approximately 45 minutes ad lib use period.
Blood pressure
Time frame: continuously during smoking. Each session is approximately 45 minutes ad lib use period.
Duke Sensory Questionnaire (DSQ)
Time frame: DSQ will be measured only after smoking. The session is approximately 45 minutes ad lib use period.
The Cigarette/WP Evaluation Scale (WES)
Time frame: WES will be measured only after smoking. The session is approximately 45 minutes 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.
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
Lung function tests (LFTs)
Time frame: During participants' 2 study visits. Lung function tests will be measured 2 times in each hookah smoking session: before and after an approximately 45 minutes 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 10 Dec 2024.
- Individual participant dataSharing planned: No
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 Test Health Warning Label (HWL) and Test without Health Warning Label (no-HWL) in people with Waterpipe Smoking and Health Warning Label, 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 4 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 10 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?
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?
Intention and motivation to quit (time frame: pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes 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 10 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.