Impact of E-cigarette Nicotine Concentration on Compensation

August 19, 2025 updated by: University of Kansas Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. identify as non-Hispanic white or non-Hispanic African American/Black
  2. willing to switch from smoking to e-cigarettes for 6 weeks
  3. speak and understand English
  4. smoke greater than or equal to 25 of the last 30 days for the past 3 months
  5. not previously used an e-cigarette for longer than 30 days
  6. exhaled carbon monoxide of greater than or equal to 6ppm at screener visit
  7. willing to abstain from marijuana for 12 hours prior to in-person lab visits
  8. willing to abstain from smoking and vaping for 12 hours prior to 3 in-person lab visits

Exclusion Criteria:

  1. weekly use of an EC over the last six months
  2. use of tobacco products other than cigarettes on greater than or equal to 10 days in the past 30 days
  3. use of EC on more than 5 of the past 30 days
  4. current use of cessation medications
  5. pregnant, planning to become pregnant, or breastfeeding
  6. past 30 day hospitalization/ER visit for psychiatric issue, seizure, stroke, or new heart problem
  7. recent history of cardiovascular or pulmonary events in the past three months
  8. treatment for alcohol or drug dependence in the past year
  9. household member currently or previously enrolled in the study
  10. current enrollment in a program aimed at changing smoking patterns

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette

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
Electronic cigarette in 5% nicotine concentration (Vuse Alto), provided for free.
Device: Electronic Cigarette with 1.8% Nicotine Concentration
Electronic cigarette in 1.8% nicotine concentration (Vuse Alto), provided for free.
Experimental: 1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette

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
Electronic cigarette in 5% nicotine concentration (Vuse Alto), provided for free.
Device: Electronic Cigarette with 1.8% Nicotine Concentration
Electronic cigarette in 1.8% nicotine concentration (Vuse Alto), provided for free.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Switch Trajectory
Time Frame: Week 6 of the Phase 2 period, approximately 8 weeks post-baseline
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]
Week 6 of the Phase 2 period, approximately 8 weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Eleanor Leavens, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

May 3, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 147694
  • K01DA054995 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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