An interventional study of Electronic Cigarette with 5% Nicotine Concentration and Electronic Cigarette with 1.8% Nicotine Concentration in Smoking Cessation, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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.
1. 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.
304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.
This study's enrollment of 52 is below the median of 154 across 285 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
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Exclusion Criteria:
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.
Device: Electronic Cigarette with 5% Nicotine Concentration · Device: Electronic Cigarette with 1.8% Nicotine Concentration
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.
Device: Electronic Cigarette with 5% Nicotine Concentration · Device: Electronic Cigarette with 1.8% Nicotine Concentration
Electronic cigarette in 5% nicotine concentration (Vuse Alto), provided for free.
Electronic cigarette in 1.8% nicotine concentration (Vuse Alto), provided for free.
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
Time frame: 5 minutes
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 \[non-use of e-cigarettes and cigarettes with biochemical confirmation\]
Time frame: Week 6 of the Phase 2 period, approximately 8 weeks post-baseline
| Milestone | 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Phase 2: 5% Nicotine E-cigarette | Phase 2: 1.8% Nicotine E-cigarette |
|---|---|---|---|---|
| Started | 23 | 29 | 0 | 0 |
| Completed | 23 | 29 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Phase 2: 5% Nicotine E-cigarette | Phase 2: 1.8% Nicotine E-cigarette |
|---|---|---|---|---|
| Started | 23 | 29 | 0 | 0 |
| Completed | 23 | 25 | 0 | 0 |
| Not completed | 0 | 4 | 0 | 0 |
| Milestone | 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Phase 2: 5% Nicotine E-cigarette | Phase 2: 1.8% Nicotine E-cigarette |
|---|---|---|---|---|
| Started | 23 | 25 | 0 | 0 |
| Completed | 23 | 25 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Phase 2: 5% Nicotine E-cigarette | Phase 2: 1.8% Nicotine E-cigarette |
|---|---|---|---|---|
| Started | 23 | 25 | 0 | 0 |
| Completed | 22 | 23 | 0 | 0 |
| Not completed | 1 | 2 | 0 | 0 |
| Milestone | 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Phase 2: 5% Nicotine E-cigarette | Phase 2: 1.8% Nicotine E-cigarette |
|---|---|---|---|---|
| Started | 0 | 0 | 25 | 20 |
| Completed | 0 | 0 | 24 | 19 |
| Not completed | 0 | 0 | 1 | 1 |
Differences within participants in total inhaled volume in electronic cigarette puff topography during the pharmacokinetic portions of lab visit 1 and 2
| mL | 5% Nicotine E-cigarette | 1.8% Nicotine E-cigarette |
|---|---|---|
| Total Inhaled Volume | 416.5 ± 258.3 | 490.3 ± 255.1 |
Switch trajectory: biochemically confirmed \[exhaled carbon monoxide\] complete switch, use of both e-cigarettes and cigarettes, use of only cigarettes, complete cessation \[non-use of e-cigarettes and cigarettes with biochemical confirmation\]
| Participants | 5% Nicotine E-cigarette | 1.8% Nicotine E-cigarette |
|---|---|---|
| complete switch | 10 | 6 |
| use of both e-cigarettes and cigarettes | 10 | 13 |
| use of only cigarettes | 3 | 0 |
| complete cessation | 1 | 0 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 5% Nicotine E-cigarette | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| 1.8% Nicotine E-cigarette | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Total |
|---|---|---|---|
| Mean | 55.7 ± 11.9 | 55.9 ± 9.6 | 55.8 ± 10.6 |
| Sex: Female, Male(Participants) | 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Total |
|---|---|---|---|
| Female | 15 | 18 | 33 |
| Male | 8 | 11 | 19 |
| Race (NIH/OMB)(Participants) | 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette | 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 15 | 27 |
| White | 11 | 14 | 25 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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University of Kansas Medical Center