Impact of E-cigarette Nicotine Concentration on Compensation

NCT ID: NCT05887947

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-06-10

Brief 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.

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electronic Cigarette with 5% Nicotine Concentration

Intervention Type: DEVICE

Electronic cigarette in 5% nicotine concentration (Vuse Alto), provided for free.

Electronic Cigarette with 1.8% Nicotine Concentration

Intervention Type: DEVICE

Electronic cigarette in 1.8% nicotine concentration (Vuse Alto), provided for free.

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.

Group Type: EXPERIMENTAL

Electronic Cigarette with 5% Nicotine Concentration

Intervention Type: DEVICE

Electronic cigarette in 5% nicotine concentration (Vuse Alto), provided for free.

Electronic Cigarette with 1.8% Nicotine Concentration

Intervention Type: DEVICE

Electronic cigarette in 1.8% nicotine concentration (Vuse Alto), provided for free.

Interventions

Electronic Cigarette with 5% Nicotine Concentration

Electronic cigarette in 5% nicotine concentration (Vuse Alto), provided for free.

Intervention Type: DEVICE

Electronic Cigarette with 1.8% Nicotine Concentration

Electronic cigarette in 1.8% nicotine concentration (Vuse Alto), provided for free.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eleanor Leavens, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K01DA054995

Identifier Type: NIH

Identifier Source: secondary_id

View Link

147694

Identifier Type: -

Identifier Source: org_study_id