Electronic Cigarette UseNCT04192032
Assessing the Effect of Flavor on ENDS Users' Experiences and Exposures
A study testing Preferred Juul pod flavor (5% nicotine), Classic Tobacco Juul pod flavor (5% nicotine) and Preferred flavor with HWL in people with Electronic Cigarette Use, run by Florida International University at 1 site in United States.
Trial summary
Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS users. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- Preferred Juul pod flavor (5% nicotine), Classic Tobacco Juul pod flavor (5% nicotine) and Preferred flavor with HWL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 15 Mar 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy individuals (determined by physical examination).
- Age of 18-24 years.
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
- Regular Juul smokers (at least weekly for the past 3 months).
- Have abstained from Juul use 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).
- Individuals that report THC (marijuana) smoking/vaping.
- Individuals that report the use of non-commercial (i.e., street) e-cigarette liquid or products
- Individuals that report current EVALI-related symptoms (i.e., cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain, diarrhea, fever, chills, or weight loss)
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Assessing the Effect of Flavor on College-Aged JUUL ENDS Users' Experiences and Exposures
Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS users. In this study will recruit 80 young (18-24) JUUL users, in a 2x2 cross over lab study where in one condition they will use their JUUL preferred flavor and the other JUUL standard tobacco flavor. Our aims are to; Aim 1: Compare satisfaction, withdrawal suppression, and harm perception between tobacco-flavored and preferred flavor JUUL. This analysis will reveal the extent to which preferred flavor contributes to smoking satisfaction, withdrawal and craving suppression, and harm perception, compared to the standard tobacco flavor.
Aim 2: Compare puff topography and plasma nicotine levels between tobacco-flavored and preferred flavor JUUL. This analysis will examine the extent to which preferred flavor contributes to puffing behavior and toxicant exposure compared to the standard tobacco flavor.
Read more
Aim 3: Compare exhaled breath condensate (EBC) between tobacco-flavored and preferred flavor JUUL. This analysis will be the first to examine exposure to toxic aldehydes (formaldehyde, acetaldehyde, acrolein, benzaldehyde, and propionaldehyde) produced when using preferred flavor compared to the standard tobacco flavor.
Utilizing powerful clinical lab methods, this study will provide a broad testing of the effect of flavor manipulation on college-aged JUUL users, and provide experimental evidence about the potential of flavor-limitation policies on young ENDS users in the US.
Read the detailed description
The use of e-cigarettes, or electronic nicotine delivery systems (ENDS), among adolescents and young adults continues to be a major public health issue. Because of appealing design, flavor selection, and popularity on social media, JUUL ENDS have gained popularity among young people, many of whom are not aware that JUUL devices contain nicotine. Regulating ENDS flavor represents a promising approach to curb ENDS use among US youth. This project will provide a broad testing of the effect of flavor manipulation on college-aged JUUL users, and assist public health authorities by providing answers to specific questions pertinent to the potential of ENDS regulation through flavor. These include: - How would flavor manipulation influence puffing behavior and plasma nicotine levels among JUUL smokers; - how would smoking smoking preferred or tobacco flavor reflects on smoker's satisfaction, withdrawal suppression, and harm perception; - how would flavor manipulation affect toxicant exposure levels measured on exhaled breath condensate (EBC) on JUUL smokers. Answers to these questions will help public health authorities predict the impact of flavor regulation on ENDS experimentation and continued use.
Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS users. In this study, we will recruit 80 young (18-24) JUUL users. Each participant will undergo 3 JUUL smoking sessions: 1) one where they will be vaping their preferred flavor; 2) one where they will be vaping the standard classic tobacco flavor; 3) a third one in which they will be vaping their preferred flavor in a JUUL Ecigarette (JEC) device that has a health warning label (HWL) attached to it. In addition, 10 participants will be invited to come back for two additional sessions: one in which they will be vaping their preferred flavor pod with a 3% nicotine concentration, and one in which they will use their preferred flavor pod with 0% nicotine concentration. Measurement of JUUL satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted in all 5 sessions.
In the past few months, there has been an increasing number of reports of severe respiratory illness related to e-cigarette use. Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are currently investigating this outbreak. According to the CDC, these cases of e-cigarette, or vaping, associated lung injury (EVALI) have been reported in most patients that report a history of using THC-containing products, particularly those obtained off the street or from other informal sources (e.g. friends, family members, illicit dealers) (https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html). Several steps have been taken to minimize this risk (i.e., excluding marijuana and non-commercial vaping products users; excluding individuals with current potential EVALI symptoms; revision of the consent \& re-consenting of participants that still need to complete study sessions; and providing all participants with a CDC fact sheet about EVALI). For further details please refer to the "Methods" \& "Minimizing Risks" sections.
This study involves minimal risks (explained in more details below in section 8) to participants. These risks are: 1) JUUL use 2) Dependence 3) Venipuncture 4) EVALI risk. The risk involved in participating in the JUUL smoking sessions of this study will not exceed the risk that would otherwise be encountered during similar recreational sessions of JUUL smoking.
Participants will benefit by being involved in a study that can increase their awareness about the health and addictive consequences of JUUL smoking and they will be given educational materials at the end of the study that explain the health impact of e-cigarettes, the current EVALI outbreak, and include resources that are available to help with quitting such as national, state and local cessation services (please see the fact sheets attached in the methods section). The findings of this study will benefit the society at large. Understanding the effect of flavor manipulation on JUUL/ENDS users will be instrumental for local and federal health agencies' potential to curb the spread of ENDS use, and protect public health in the US.
- Conditions
- Electronic Cigarette Use
- Being tested
- Preferred Juul pod flavor (5% nicotine), Classic Tobacco Juul pod flavor (5% nicotine), Preferred flavor with HWL, Preferred flavor, 3% nicotine, Preferred flavor, 0% nicotine
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preferred Juul pod flavor (5% nicotine)Other
Preferred Juul pod flavor (5% nicotine)
Classic Tobacco Juul pod flavor (5% nicotine)Other
Classic Tobacco Juul pod flavor (5% nicotine)
Preferred flavor with HWLOther
Preferred flavor (5% nicotine) with HWL
Preferred flavor, 3% nicotineOther
Preferred flavor, 3% nicotine
Preferred flavor, 0% nicotineOther
Preferred flavor, 0% nicotine
| Study group | Role | What they receive |
|---|---|---|
| Preferred flavor (5% nicotine) | Experimental | Preferred flavor Juul pod (5% nicotine) Receives: Other: Preferred Juul pod flavor (5% nicotine) |
| Classic Tobacco Flavor | Active comparator | Control flavor (5% Classic Tobacco flavor Juul pod) Receives: Other: Classic Tobacco Juul pod flavor (5% nicotine) |
| Preferred flavor with HWL | Experimental | Preferred flavored Juul pod (5% nicotine) with HWL Receives: Other: Preferred flavor with HWL |
| Preferred flavor (3% nicotine) | Experimental | Preferred flavored Juul pod (3% nicotine) Receives: Other: Preferred flavor, 3% nicotine |
| Preferred flavor (0% nicotine) | Experimental | Preferred flavored Juul pod (0% nicotine) Receives: Other: Preferred flavor, 0% nicotine |
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 five participant visits. Blood will be taken 2 times in each JUUL use session: before and after an approximately 60-min ad lib use period
Secondary outcomes (7)
Puff topography
Measurement of puffing behavior
Measured: During participants' five study visits. Puffing behavior is continuously measured during each Juul use session (an approximately 60-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' five study visits. Questionnaire will be administered 2 times in each Juul use session: before and after an approximately 60-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' five study visits. Questionnaire will be administered 2 times in each Juul use session: before and after an approximately 60-min ad lib use period.]
Carbon monoxide levels
Change in carbon monoxide levels (in parts per million)
Measured: During participants' five study visits. Carbon monoxide levels will be measured 2 times in each Juul use session: before and after an approximately 60-min ad lib use period
Harm perception
This scale will 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' five study visits. Questionnaire will be administered after each of the 2 Juul use sessions. Each session is approximately 60-min ad lib use period.]
Duke Sensory Questionnaire
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: During participants' five study visits. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 60-min ad lib use period.]
The Cigarette/ENDS Evaluation Scale (WES)
This scale assesses participants' perception of ENDS use. 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' five study visits. Questionnaire will be administered after each of the 2 Juul use sessions. Each session is approximately 60-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 posted10 Dec 2019
- Study start15 Nov 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Cigarette UseStudies 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
- Model description
- In this study, we will recruit 80 young (18-24) JUUL users. Each participant will undergo 3 JUUL smoking sessions: 1) one where they will be vaping their preferred flavor; 2) one where they will be vaping the standard classic tobacco flavor; 3) a third one in which they will be vaping their preferred flavor in a JUUL Ecigarette (JEC) device that has a health warning label (HWL) attached to it. In addition, 10 participants will be invited to come back for two additional sessions: one in which they will be vaping their preferred flavor pod with a 3% nicotine concentration, and one in which they will use their preferred flavor pod with 0% nicotine concentration. Measurement of JUUL satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted in all 5 sessions.
- Masking
- None (open label)
- Enrolment
- 41 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
- Investigators
- Wasim Maziak, MD, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192032
- Sponsor's protocol ID
- 107308
- Status last verified
- Jan 2021
- First submitted
- 2 Dec 2019
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Flavor on College-Aged JUUL ENDS Users' Experiences and Exposures
- ClinicalTrials.gov ID
- NCT04192032
- Acronym / sponsor ID
- 107308
- Conditions
- Electronic Cigarette Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 10 Dec 2019 (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.
Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS users. In this study will recruit 80 young (18-24) JUUL users, in a 2x2 cross over lab study where in one condition they will use their JUUL preferred flavor and the other JUUL standard tobacco flavor. Our aims are to; Aim 1: Compare satisfaction, withdrawal suppression, and harm perception between tobacco-flavored and preferred flavor JUUL. This analysis will reveal the extent to which preferred flavor contributes to smoking satisfaction, withdrawal and craving suppression, and harm perception, compared to the standard tobacco flavor.
Aim 2: Compare puff topography and plasma nicotine levels between tobacco-flavored and preferred flavor JUUL. This analysis will examine the extent to which preferred flavor contributes to puffing behavior and toxicant exposure compared to the standard tobacco flavor.
Aim 3: Compare exhaled breath condensate (EBC) between tobacco-flavored and preferred flavor JUUL. This analysis will be the first to examine exposure to toxic aldehydes (formaldehyde, acetaldehyde, acrolein, benzaldehyde, and propionaldehyde) produced when using preferred flavor compared to the standard tobacco flavor.
Utilizing powerful clinical lab methods, this study will provide a broad testing of the effect of flavor manipulation on college-aged JUUL users, and provide experimental evidence about the potential of flavor-limitation policies on young ENDS users in the US.
Detailed description
The use of e-cigarettes, or electronic nicotine delivery systems (ENDS), among adolescents and young adults continues to be a major public health issue. Because of appealing design, flavor selection, and popularity on social media, JUUL ENDS have gained popularity among young people, many of whom are not aware that JUUL devices contain nicotine. Regulating ENDS flavor represents a promising approach to curb ENDS use among US youth. This project will provide a broad testing of the effect of flavor manipulation on college-aged JUUL users, and assist public health authorities by providing answers to specific questions pertinent to the potential of ENDS regulation through flavor. These include: - How would flavor manipulation influence puffing behavior and plasma nicotine levels among JUUL smokers; - how would smoking smoking preferred or tobacco flavor reflects on smoker's satisfaction, withdrawal suppression, and harm perception; - how would flavor manipulation affect toxicant exposure levels measured on exhaled breath condensate (EBC) on JUUL smokers. Answers to these questions will help public health authorities predict the impact of flavor regulation on ENDS experimentation and continued use.
Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS users. In this study, we will recruit 80 young (18-24) JUUL users. Each participant will undergo 3 JUUL smoking sessions: 1) one where they will be vaping their preferred flavor; 2) one where they will be vaping the standard classic tobacco flavor; 3) a third one in which they will be vaping their preferred flavor in a JUUL Ecigarette (JEC) device that has a health warning label (HWL) attached to it. In addition, 10 participants will be invited to come back for two additional sessions: one in which they will be vaping their preferred flavor pod with a 3% nicotine concentration, and one in which they will use their preferred flavor pod with 0% nicotine concentration. Measurement of JUUL satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted in all 5 sessions.
In the past few months, there has been an increasing number of reports of severe respiratory illness related to e-cigarette use. Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are currently investigating this outbreak. According to the CDC, these cases of e-cigarette, or vaping, associated lung injury (EVALI) have been reported in most patients that report a history of using THC-containing products, particularly those obtained off the street or from other informal sources (e.g. friends, family members, illicit dealers) (https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html). Several steps have been taken to minimize this risk (i.e., excluding marijuana and non-commercial vaping products users; excluding individuals with current potential EVALI symptoms; revision of the consent \& re-consenting of participants that still need to complete study sessions; and providing all participants with a CDC fact sheet about EVALI). For further details please refer to the "Methods" \& "Minimizing Risks" sections.
This study involves minimal risks (explained in more details below in section 8) to participants. These risks are: 1) JUUL use 2) Dependence 3) Venipuncture 4) EVALI risk. The risk involved in participating in the JUUL smoking sessions of this study will not exceed the risk that would otherwise be encountered during similar recreational sessions of JUUL smoking.
Participants will benefit by being involved in a study that can increase their awareness about the health and addictive consequences of JUUL smoking and they will be given educational materials at the end of the study that explain the health impact of e-cigarettes, the current EVALI outbreak, and include resources that are available to help with quitting such as national, state and local cessation services (please see the fact sheets attached in the methods section). The findings of this study will benefit the society at large. Understanding the effect of flavor manipulation on JUUL/ENDS users will be instrumental for local and federal health agencies' potential to curb the spread of ENDS use, and protect public health in the US.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- In this study, we will recruit 80 young (18-24) JUUL users. Each participant will undergo 3 JUUL smoking sessions: 1) one where they will be vaping their preferred flavor; 2) one where they will be vaping the standard classic tobacco flavor; 3) a third one in which they will be vaping their preferred flavor in a JUUL Ecigarette (JEC) device that has a health warning label (HWL) attached to it. In addition, 10 participants will be invited to come back for two additional sessions: one in which they will be vaping their preferred flavor pod with a 3% nicotine concentration, and one in which they will use their preferred flavor pod with 0% nicotine concentration. Measurement of JUUL satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted in all 5 sessions.
| Arm | Type | Receives |
|---|---|---|
| Preferred flavor (5% nicotine) | Experimental | Other: Preferred Juul pod flavor (5% nicotine)Preferred flavor Juul pod (5% nicotine) |
| Classic Tobacco Flavor | Active comparator | Other: Classic Tobacco Juul pod flavor (5% nicotine)Control flavor (5% Classic Tobacco flavor Juul pod) |
| Preferred flavor with HWL | Experimental | Other: Preferred flavor with HWLPreferred flavored Juul pod (5% nicotine) with HWL |
| Preferred flavor (3% nicotine) | Experimental | Other: Preferred flavor, 3% nicotinePreferred flavored Juul pod (3% nicotine) |
| Preferred flavor (0% nicotine) | Experimental | Other: Preferred flavor, 0% nicotinePreferred flavored Juul pod (0% nicotine) |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Generally healthy individuals (determined by physical examination).
- Age of 18-24 years.
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
- Regular Juul smokers (at least weekly for the past 3 months).
Key exclusion criteria (8 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 |
|---|---|---|
| Preferred Juul pod flavor (5% nicotine)Preferred Juul pod flavor (5% nicotine) | Other | Preferred flavor (5% nicotine) |
| Classic Tobacco Juul pod flavor (5% nicotine)Classic Tobacco Juul pod flavor (5% nicotine) | Other | Classic Tobacco Flavor |
| Preferred flavor with HWLPreferred flavor (5% nicotine) with HWL | Other | Preferred flavor with HWL |
| Preferred flavor, 3% nicotinePreferred flavor, 3% nicotine | Other | Preferred flavor (3% nicotine) |
| Preferred flavor, 0% nicotinePreferred flavor, 0% nicotine | Other | Preferred flavor (0% nicotine) |
Primary outcome
Plasma nicotine
Time frame: During five participant visits. Blood will be taken 2 times in each JUUL use session: before and after an approximately 60-min ad lib use period
Change in plasma nicotine level
7 secondary outcomes
Puff topography
Time frame: During participants' five study visits. Puffing behavior is continuously measured during each Juul use session (an approximately 60-min ad lib use period)
Minnesota Nicotine Withdrawal Scale
Time frame: During participants' five study visits. Questionnaire will be administered 2 times in each Juul use session: before and after an approximately 60-min ad lib use period.]
Tiffany-Drobes Questionnaire of Smoking Urges
Time frame: During participants' five study visits. Questionnaire will be administered 2 times in each Juul use session: before and after an approximately 60-min ad lib use period.]
Carbon monoxide levels
Time frame: During participants' five study visits. Carbon monoxide levels will be measured 2 times in each Juul use session: before and after an approximately 60-min ad lib use period
Harm perception
Time frame: During participants' five study visits. Questionnaire will be administered after each of the 2 Juul use sessions. Each session is approximately 60-min ad lib use period.]
Duke Sensory Questionnaire
Time frame: During participants' five study visits. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 60-min ad lib use period.]
The Cigarette/ENDS Evaluation Scale (WES)
Time frame: During participants' five study visits. Questionnaire will be administered after each of the 2 Juul use sessions. Each session is approximately 60-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 26 Jan 2021.
- 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.
Wasim Maziak, MD, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preferred Juul pod flavor (5% nicotine), Classic Tobacco Juul pod flavor (5% nicotine) and Preferred flavor with HWL in people with Electronic Cigarette Use, 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 8 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 26 Jan 2021. 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 five participant visits. Blood will be taken 2 times in each JUUL use session: before and after an approximately 60-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 26 Jan 2021.