Smoking CessationNCT05887947
Impact of E-cigarette Nicotine Concentration on Compensation
A study testing Electronic Cigarette with 5% Nicotine Concentration and Electronic Cigarette with 1.8% Nicotine Concentration in people with Smoking Cessation, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The study will be the first to assess the impact of nicotine concentration on compensatory puffing (total inhaled volume), nicotine delivery, and switch patterns (percent exclusive EC, dual cig-EC, and cig only users) with an explicit focus on AA and White smokers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Electronic Cigarette with 5% Nicotine Concentration and Electronic Cigarette with 1.8% Nicotine Concentration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 10 Jun 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- identify as non-Hispanic white or non-Hispanic African American/Black
- willing to switch from smoking to e-cigarettes for 6 weeks
- speak and understand English
- smoke greater than or equal to 25 of the last 30 days for the past 3 months
- not previously used an e-cigarette for longer than 30 days
- exhaled carbon monoxide of greater than or equal to 6ppm at screener visit
- willing to abstain from marijuana for 12 hours prior to in-person lab visits
- willing to abstain from smoking and vaping for 12 hours prior to 3 in-person lab visits
Who cannot join
- weekly use of an EC over the last six months
- use of tobacco products other than cigarettes on greater than or equal to 10 days in the past 30 days
- use of EC on more than 5 of the past 30 days
- current use of cessation medications
- pregnant, planning to become pregnant, or breastfeeding
- past 30 day hospitalization/ER visit for psychiatric issue, seizure, stroke, or new heart problem
Show all 10Show fewer
- recent history of cardiovascular or pulmonary events in the past three months
- treatment for alcohol or drug dependence in the past year
- household member currently or previously enrolled in the study
- current enrollment in a program aimed at changing smoking patterns
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Impact of E-cigarette Nicotine Concentration on Compensation, Cigarette Smoking, and Biomarkers of Exposure and Harm in Diverse Smokers
The study will be the first to assess the impact of nicotine concentration on compensatory puffing (total inhaled volume), nicotine delivery, and switch patterns (percent exclusive EC, dual cig-EC, and cig only users) with an explicit focus on AA and White smokers.
Read the detailed description
- E-cigarettes (ECs) are projected to exceed combustible cigarette use within two years. Policy makers, health officials, and regulators are concerned that newer nicotine salt-based Ecs that use high concentrations of nicotine in their e-liquids are a major reason for this rapid growth in use. The US Food and Drug Administration (FDA) has regulatory authority to set appropriate tobacco product standards to protect public health and has shown interest in exploring a product standard limiting the level of nicotine in e-liquids. While this regulatory consideration has merit, emerging research suggests it may be misguided, leading to a product that is just as addictive but more harmful. Specifically, among users of earlier, freebase nicotine Ecs (i.e., cig-a-like, tank systems), use of low nicotine e-liquids was associated with a 9-fold increase in e-liquid consumption and all of its related toxicants, likely due to compensatory puffing. The consequences of consuming more e-liquid because of lower nicotine concentration remains an important knowledge gap. Moreover, the National Academies of Science, Engineering, and Medicine have concluded that completely substituting Ecs for cigarettes results in less short-term harm than continued smoking, but the impact of low versus high nicotine concentration e-liquids on a smokers' ability to completely switch to Ecs (versus become 'dual users' or continue smoking) is currently unknown. African American (AA) smokers, who take larger puffs, inhale more intensely, and extract more nicotine and harmful constituents per cigarette smoked, may be particularly impacted by nicotine product standards placed on EC - i.e., greater compensatory puffing and more e-liquid and related toxicant consumption at lower e-liquid concentrations. Unfortunately, the vast majority of information on Ecs and potential product standards come from white populations and have largely ignored African American (AA) smokers who bear a disproportionate burden of tobacco-related morbidity and mortality. As the FDA considers regulatory action to limit the level of nicotine in e-liquids to protect public health, it is critical that research considers vulnerable populations and does not widen disparities.
The long-term goal is to inform a tobacco landscape that will minimize tobacco-related harms and downstream health inequities. The overall objective of this application is to understand the impact of e-liquid nicotine concentration on compensatory puffing, EC and cigarette use patterns (exclusive EC, dual EC-cig, exclusive cig), and resultant exposure to biomarkers of harm among AA and white smokers. Adult AA and white smokers will complete two study phases. In Phase 1, using a randomized crossover design, participants will complete two standardized, 10-puff vaping bouts over 5 mins followed by a 60-minute ad libitum vaping session, using two e-liquids that differ only by nicotine concentration (5% vs. 1.8%) to examine the effect of nicotine concentration on in-lab compensatory puffing, nicotine exposure, and e-liquid consumption. In Phase 2, the same participants will be randomized to 5% or 1.8% nicotine e-liquid and instructed to switch completely for 6 weeks to examine the impact of nicotine concentration on short-term and real-world EC use patterns. The central hypothesis is that, compared to the high nicotine concentration, while vaping the low nicotine concentration, users will engage in compensatory puffing, resulting in greater e-liquid consumption (Phase 1). Moreover, rates of dual use and continued smoking will be higher for the low (versus high) nicotine concentration.
- Conditions
- Smoking Cessation
- Being tested
- Electronic Cigarette with 5% Nicotine Concentration, Electronic Cigarette with 1.8% Nicotine Concentration
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Cigarette with 5% Nicotine ConcentrationDevice
Electronic cigarette in 5% nicotine concentration (Vuse Alto), provided for free.
Electronic Cigarette with 1.8% Nicotine ConcentrationDevice
Electronic cigarette in 1.8% nicotine concentration (Vuse Alto), provided for free.
| Study group | Role | What they receive |
|---|---|---|
| 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | Experimental | At lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session. Receives: Device: Electronic Cigarette with 5% Nicotine Concentration; Device: Electronic Cigarette with 1.8% Nicotine Concentration |
| 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Experimental | At lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session.
After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session. Receives: Device: Electronic Cigarette with 5% Nicotine Concentration; Device: Electronic Cigarette with 1.8% Nicotine Concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Inhaled Volume
Differences within participants in total inhaled volume in electronic cigarette puff topography during the pharmacokinetic portions of lab visit 1 and 2
Measured: 5 minutes
Secondary outcomes (1)
Participant Switch Trajectory
Switch trajectory: biochemically confirmed [exhaled carbon monoxide] complete switch, use of both e-cigarettes and cigarettes, use of only cigarettes, complete cessation [non-use of e-cigarettes and cigarettes with biochemical confirmation]
Measured: Week 6 of the Phase 2 period, approximately 8 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start20 Feb 2023
- Primary completion3 May 2024
- Study completion10 Jun 2024
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.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We will conduct a 2x2 crossover study and utilize linear mixed effects models to assess differences in total inhaled volume between 1.8% and 5% nicotine concentration. Phase 1 (P1): 2-visit human laboratory trial with double-blind, randomized crossover design. Phase 2 (P2): 6-week, randomized substitution trial. Participants in P2 will be the same participants that completed P1.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Eleanor Leavens, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887947
- Sponsor's protocol ID
- 147694
- Other IDs
- K01DA054995
- Status last verified
- Aug 2025
- First submitted
- 12 May 2023
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Leavens EL, Driskill LM, Molina N, Eissenberg T, Shihadeh A, Brett EI, Floyd E, Wagener TL. Comparison of a preferred versus non-preferred waterpipe tobacco flavour: subjective experience, smoking behaviour and toxicant exposure. Tob Control. 2018 May;27(3):319-324. doi: 10.1136/tobaccocontrol-2016-053344. Epub 2017 Apr 5.
PubMed 28381414Wagener TL, Leavens ELS, Mehta T, Hale J, Shihadeh A, Eissenberg T, Halquist M, Brinkman MC, Johnson AL, Floyd EL, Ding K, El Hage R, Salman R. Impact of flavors and humectants on waterpipe tobacco smoking topography, subjective effects, toxicant exposure and intentions for continued use. Tob Control. 2020 May 13:tobaccocontrol-2019-055509. doi: 10.1136/tobaccocontrol-2019-055509. Online ahead of print.
PubMed 32404518Leavens ELS, Morgan TL, Brett EI, Patzkowsky K, Son J, Molina N, Eissenberg T, Shihadeh A, Leffingwell TR, Wagener TL. Concurrent Alcohol Use and Waterpipe Tobacco Smoking: Smoking Topography, Toxicant Exposure, and Abuse Liability. Nicotine Tob Res. 2020 Feb 6;22(2):280-287. doi: 10.1093/ntr/ntz032.
PubMed 30820567Leavens ELS, Smith TT, Natale N, Carpenter MJ. Electronic cigarette dependence and demand among pod mod users as a function of smoking status. Psychol Addict Behav. 2020 Nov;34(7):804-810. doi: 10.1037/adb0000583. Epub 2020 Apr 16.
PubMed 32297753Leavens ELS, Stevens EM, Brett EI, Hebert ET, Villanti AC, Pearson JL, Wagener TL. JUUL electronic cigarette use patterns, other tobacco product use, and reasons for use among ever users: Results from a convenience sample. Addict Behav. 2019 Aug;95:178-183. doi: 10.1016/j.addbeh.2019.02.011. Epub 2019 Feb 18.
PubMed 30933713Leavens ELS, Stevens EM, Brett EI, Leffingwell TR, Wagener TL. JUUL in school: JUUL electronic cigarette use patterns, reasons for use, and social normative perceptions among college student ever users. Addict Behav. 2019 Dec;99:106047. doi: 10.1016/j.addbeh.2019.106047. Epub 2019 Jul 9.
PubMed 31442788Wagener TL, Avery JA, Leavens ELS, Simmons WK. Associated Changes in E-cigarette Puff Duration and Cigarettes Smoked per Day. Nicotine Tob Res. 2021 Mar 19;23(4):760-764. doi: 10.1093/ntr/ntaa211.
PubMed 33049064Stevens EM, Hebert ET, Tackett AP, Leavens ELS, Wagener TL. Harm Perceptions of the JUUL E-Cigarette in a Sample of Ever Users. Int J Environ Res Public Health. 2020 Jul 2;17(13):4755. doi: 10.3390/ijerph17134755.
PubMed 32630647Wedel AV, Stevens EM, Molina N, Leavens ELS, Roberts C, Wagener TL. Examining pregnant smokers' attitudes toward cessation aids and electronic nicotine delivery systems. J Okla State Med Assoc. 2018 Oct;111(8):812-816.
PubMed 31404418Waseh S, Dicker AP. Telemedicine Training in Undergraduate Medical Education: Mixed-Methods Review. JMIR Med Educ. 2019 Apr 8;5(1):e12515. doi: 10.2196/12515.
PubMed 30958269Leavens ELS, Lechner WV, Stevens EM, Miller MB, Meier E, Brett EI, Moisiuc A, Hale JJ, Wagener TL. Electronic cigarette and combustible cigarette use following a campus-wide ban: Prevalence of use and harm perceptions. J Am Coll Health. 2020 May-Jun;68(4):332-335. doi: 10.1080/07448481.2018.1551803. Epub 2019 Jan 25.
PubMed 30681933Leavens ELS, Meier E, Brett EI, Stevens EM, Tackett AP, Villanti AC, Wagener TL. Polytobacco use and risk perceptions among young adults: The potential role of habituation to risk. Addict Behav. 2019 Mar;90:278-284. doi: 10.1016/j.addbeh.2018.11.003. Epub 2018 Nov 8.
PubMed 30472536Tackett AP, Leavens ELS, Wiedenmann A, Perez MN, Baker A, Mayes S, Mullins LL, Wagener TL. Preliminary exploration of secondhand smoke exposure in youth with Sickle Cell Disease: biochemical verification, pulmonary functioning, and health care utilization. Psychol Health Med. 2019 Jan;24(1):35-42. doi: 10.1080/13548506.2018.1516294. Epub 2018 Sep 11.
PubMed 30203658Leavens ELS, Brett EI, Morgan TL, Lopez SV, Shaikh RA, Leffingwell TR, Wagener TL. Descriptive and injunctive norms of waterpipe smoking among college students. Addict Behav. 2018 Feb;77:59-62. doi: 10.1016/j.addbeh.2017.09.006. Epub 2017 Sep 18.
PubMed 28963891Leavens ELS, Meier E, Tackett AP, Miller MB, Tahirkheli NN, Brett EI, Carroll DM, Driskill LM, Anderson MP, Wagener TL. The impact of a brief cessation induction intervention for waterpipe tobacco smoking: A pilot randomized clinical trial. Addict Behav. 2018 Mar;78:94-100. doi: 10.1016/j.addbeh.2017.10.023. Epub 2017 Oct 28.
PubMed 29128712
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of E-cigarette Nicotine Concentration on Compensation, Cigarette Smoking, and Biomarkers of Exposure and Harm in Diverse Smokers
- ClinicalTrials.gov ID
- NCT05887947
- Acronym / sponsor ID
- 147694
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Posted 10 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be the first to assess the impact of nicotine concentration on compensatory puffing (total inhaled volume), nicotine delivery, and switch patterns (percent exclusive EC, dual cig-EC, and cig only users) with an explicit focus on AA and White smokers.
Detailed description
- E-cigarettes (ECs) are projected to exceed combustible cigarette use within two years. Policy makers, health officials, and regulators are concerned that newer nicotine salt-based Ecs that use high concentrations of nicotine in their e-liquids are a major reason for this rapid growth in use. The US Food and Drug Administration (FDA) has regulatory authority to set appropriate tobacco product standards to protect public health and has shown interest in exploring a product standard limiting the level of nicotine in e-liquids. While this regulatory consideration has merit, emerging research suggests it may be misguided, leading to a product that is just as addictive but more harmful. Specifically, among users of earlier, freebase nicotine Ecs (i.e., cig-a-like, tank systems), use of low nicotine e-liquids was associated with a 9-fold increase in e-liquid consumption and all of its related toxicants, likely due to compensatory puffing. The consequences of consuming more e-liquid because of lower nicotine concentration remains an important knowledge gap. Moreover, the National Academies of Science, Engineering, and Medicine have concluded that completely substituting Ecs for cigarettes results in less short-term harm than continued smoking, but the impact of low versus high nicotine concentration e-liquids on a smokers' ability to completely switch to Ecs (versus become 'dual users' or continue smoking) is currently unknown. African American (AA) smokers, who take larger puffs, inhale more intensely, and extract more nicotine and harmful constituents per cigarette smoked, may be particularly impacted by nicotine product standards placed on EC - i.e., greater compensatory puffing and more e-liquid and related toxicant consumption at lower e-liquid concentrations. Unfortunately, the vast majority of information on Ecs and potential product standards come from white populations and have largely ignored African American (AA) smokers who bear a disproportionate burden of tobacco-related morbidity and mortality. As the FDA considers regulatory action to limit the level of nicotine in e-liquids to protect public health, it is critical that research considers vulnerable populations and does not widen disparities.
The long-term goal is to inform a tobacco landscape that will minimize tobacco-related harms and downstream health inequities. The overall objective of this application is to understand the impact of e-liquid nicotine concentration on compensatory puffing, EC and cigarette use patterns (exclusive EC, dual EC-cig, exclusive cig), and resultant exposure to biomarkers of harm among AA and white smokers. Adult AA and white smokers will complete two study phases. In Phase 1, using a randomized crossover design, participants will complete two standardized, 10-puff vaping bouts over 5 mins followed by a 60-minute ad libitum vaping session, using two e-liquids that differ only by nicotine concentration (5% vs. 1.8%) to examine the effect of nicotine concentration on in-lab compensatory puffing, nicotine exposure, and e-liquid consumption. In Phase 2, the same participants will be randomized to 5% or 1.8% nicotine e-liquid and instructed to switch completely for 6 weeks to examine the impact of nicotine concentration on short-term and real-world EC use patterns. The central hypothesis is that, compared to the high nicotine concentration, while vaping the low nicotine concentration, users will engage in compensatory puffing, resulting in greater e-liquid consumption (Phase 1). Moreover, rates of dual use and continued smoking will be higher for the low (versus high) nicotine concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- We will conduct a 2x2 crossover study and utilize linear mixed effects models to assess differences in total inhaled volume between 1.8% and 5% nicotine concentration. Phase 1 (P1): 2-visit human laboratory trial with double-blind, randomized crossover design. Phase 2 (P2): 6-week, randomized substitution trial. Participants in P2 will be the same participants that completed P1.
| Arm | Type | Receives |
|---|---|---|
| 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | Experimental | Device: Electronic Cigarette with 5% Nicotine Concentration, Device: Electronic Cigarette with 1.8% Nicotine ConcentrationAt lab visit 1 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session. After a washout period of at least 48 hours, at lab visit 2 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session. |
| 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Experimental | Device: Electronic Cigarette with 5% Nicotine Concentration, Device: Electronic Cigarette with 1.8% Nicotine ConcentrationAt lab visit 1 participants receive 1.8% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session. After a washout period of at least 48 hours, at lab visit 2 participants receive 5% electronic cigarette pod nicotine concentration during the 10-puff standardized puff bout and 60-minute ad libitum session. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- identify as non-Hispanic white or non-Hispanic African American/Black
- willing to switch from smoking to e-cigarettes for 6 weeks
- speak and understand English
- smoke greater than or equal to 25 of the last 30 days for the past 3 months
- not previously used an e-cigarette for longer than 30 days
Key exclusion criteria (10 listed)
- weekly use of an EC over the last six months
- use of tobacco products other than cigarettes on greater than or equal to 10 days in the past 30 days
- use of EC on more than 5 of the past 30 days
- current use of cessation medications
- pregnant, planning to become pregnant, or breastfeeding
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 |
|---|---|---|
| Electronic Cigarette with 5% Nicotine ConcentrationElectronic cigarette in 5% nicotine concentration (Vuse Alto), provided for free. | Device | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette, 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette |
| Electronic Cigarette with 1.8% Nicotine ConcentrationElectronic cigarette in 1.8% nicotine concentration (Vuse Alto), provided for free. | Device | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette, 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette |
Primary outcome
Total Inhaled Volume
Time frame: 5 minutes
Differences within participants in total inhaled volume in electronic cigarette puff topography during the pharmacokinetic portions of lab visit 1 and 2
1 secondary outcome
Participant Switch Trajectory
Time frame: Week 6 of the Phase 2 period, approximately 8 weeks post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28381414Leavens EL, Driskill LM, Molina N, Eissenberg T, Shihadeh A, Brett EI, Floyd E, Wagener TL. Comparison of a preferred versus non-preferred waterpipe tobacco flavour: subjective experience, smoking behaviour and toxicant exposure. Tob Control. 2018 May;27(3):319-324. doi: 10.1136/tobaccocontrol-2016-053344. Epub 2017 Apr 5.
- Background: PubMed 32404518Wagener TL, Leavens ELS, Mehta T, Hale J, Shihadeh A, Eissenberg T, Halquist M, Brinkman MC, Johnson AL, Floyd EL, Ding K, El Hage R, Salman R. Impact of flavors and humectants on waterpipe tobacco smoking topography, subjective effects, toxicant exposure and intentions for continued use. Tob Control. 2020 May 13:tobaccocontrol-2019-055509. doi: 10.1136/tobaccocontrol-2019-055509. Online ahead of print.
- Background: PubMed 30820567Leavens ELS, Morgan TL, Brett EI, Patzkowsky K, Son J, Molina N, Eissenberg T, Shihadeh A, Leffingwell TR, Wagener TL. Concurrent Alcohol Use and Waterpipe Tobacco Smoking: Smoking Topography, Toxicant Exposure, and Abuse Liability. Nicotine Tob Res. 2020 Feb 6;22(2):280-287. doi: 10.1093/ntr/ntz032.
- Background: PubMed 32297753Leavens ELS, Smith TT, Natale N, Carpenter MJ. Electronic cigarette dependence and demand among pod mod users as a function of smoking status. Psychol Addict Behav. 2020 Nov;34(7):804-810. doi: 10.1037/adb0000583. Epub 2020 Apr 16.
- Background: PubMed 30933713Leavens ELS, Stevens EM, Brett EI, Hebert ET, Villanti AC, Pearson JL, Wagener TL. JUUL electronic cigarette use patterns, other tobacco product use, and reasons for use among ever users: Results from a convenience sample. Addict Behav. 2019 Aug;95:178-183. doi: 10.1016/j.addbeh.2019.02.011. Epub 2019 Feb 18.
- Background: PubMed 31442788Leavens ELS, Stevens EM, Brett EI, Leffingwell TR, Wagener TL. JUUL in school: JUUL electronic cigarette use patterns, reasons for use, and social normative perceptions among college student ever users. Addict Behav. 2019 Dec;99:106047. doi: 10.1016/j.addbeh.2019.106047. Epub 2019 Jul 9.
- Background: PubMed 33049064Wagener TL, Avery JA, Leavens ELS, Simmons WK. Associated Changes in E-cigarette Puff Duration and Cigarettes Smoked per Day. Nicotine Tob Res. 2021 Mar 19;23(4):760-764. doi: 10.1093/ntr/ntaa211.
- Background: PubMed 32630647Stevens EM, Hebert ET, Tackett AP, Leavens ELS, Wagener TL. Harm Perceptions of the JUUL E-Cigarette in a Sample of Ever Users. Int J Environ Res Public Health. 2020 Jul 2;17(13):4755. doi: 10.3390/ijerph17134755.
- Background: PubMed 31404418Wedel AV, Stevens EM, Molina N, Leavens ELS, Roberts C, Wagener TL. Examining pregnant smokers' attitudes toward cessation aids and electronic nicotine delivery systems. J Okla State Med Assoc. 2018 Oct;111(8):812-816.
- Background: PubMed 30958269Waseh S, Dicker AP. Telemedicine Training in Undergraduate Medical Education: Mixed-Methods Review. JMIR Med Educ. 2019 Apr 8;5(1):e12515. doi: 10.2196/12515.
- Background: PubMed 30681933Leavens ELS, Lechner WV, Stevens EM, Miller MB, Meier E, Brett EI, Moisiuc A, Hale JJ, Wagener TL. Electronic cigarette and combustible cigarette use following a campus-wide ban: Prevalence of use and harm perceptions. J Am Coll Health. 2020 May-Jun;68(4):332-335. doi: 10.1080/07448481.2018.1551803. Epub 2019 Jan 25.
- Background: PubMed 30472536Leavens ELS, Meier E, Brett EI, Stevens EM, Tackett AP, Villanti AC, Wagener TL. Polytobacco use and risk perceptions among young adults: The potential role of habituation to risk. Addict Behav. 2019 Mar;90:278-284. doi: 10.1016/j.addbeh.2018.11.003. Epub 2018 Nov 8.
- 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.
Eleanor Leavens, PhD principal investigator
University of Kansas Medical 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 Electronic Cigarette with 5% Nicotine Concentration and Electronic Cigarette with 1.8% Nicotine Concentration in people with Smoking Cessation, run by University of Kansas Medical 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 8 inclusion and 10 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 Sep 2025. 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 10 Sep 2025). 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?
Total Inhaled Volume (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05887947, which also lists 18 linked publications.
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 Sep 2025.