Impact of E-cigarette Nicotine Concentration on Compensation

NCT05887947 | Completed Results FDA Device

• 2 other identifiers: 147694K01DA054995
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

  5 minutes

Secondary Outcomes (1)

• Participant Switch Trajectory

  Week 6 of the Phase 2 period, approximately 8 weeks post-baseline

Study Arms (2)

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.

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.

Device: Electronic Cigarette with 5% Nicotine Concentration; Device: Electronic Cigarette with 1.8% Nicotine Concentration

Interventions

Electronic Cigarette with 5% Nicotine Concentration DEVICE

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

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 Concentration DEVICE

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

1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette; 5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (18)

• 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.

  PMID: 28381414 BACKGROUND

• Wagener 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.

  PMID: 32404518 BACKGROUND

• Leavens 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.

  PMID: 30820567 BACKGROUND

• Leavens 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.

  PMID: 32297753 BACKGROUND

• Leavens 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.

  PMID: 30933713 BACKGROUND

• Leavens 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.

  PMID: 31442788 BACKGROUND

• Wagener 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.

  PMID: 33049064 BACKGROUND

• Stevens 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.

  PMID: 32630647 BACKGROUND

• Wedel 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.

  PMID: 31404418 BACKGROUND

• Waseh 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.

  PMID: 30958269 BACKGROUND

• Leavens 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.

  PMID: 30681933 BACKGROUND

• Leavens 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.

  PMID: 30472536 BACKGROUND

• Tackett 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.

  PMID: 30203658 BACKGROUND

• Leavens 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.

  PMID: 28963891 BACKGROUND

• Leavens 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.

  PMID: 29128712 BACKGROUND

• Leavens EL, Brett EI, Frank S, Shaikh RA, Leffingwell TR, Croff JM, Wagener TL. Association between breath alcohol concentration and waterpipe lounge patrons' carbon monoxide exposure: A field investigation. Drug Alcohol Depend. 2017 Jan 1;170:152-155. doi: 10.1016/j.drugalcdep.2016.11.010. Epub 2016 Nov 16.

  PMID: 27918950 BACKGROUND

• Busch AM, Leavens EL, Wagener TL, Buckley ML, Tooley EM. Prevalence, Reasons for Use, and Risk Perception of Electronic Cigarettes Among Post-Acute Coronary Syndrome Smokers. J Cardiopulm Rehabil Prev. 2016 Sep-Oct;36(5):352-7. doi: 10.1097/HCR.0000000000000179.

  PMID: 27120039 BACKGROUND

• Brett EI, Miller MB, Leavens ELS, Lopez SV, Wagener TL, Leffingwell TR. Electronic cigarette use and sleep health in young adults. J Sleep Res. 2020 Jun;29(3):e12902. doi: 10.1111/jsr.12902. Epub 2019 Sep 4.

  PMID: 31486154 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Eleanor Leavens
• Organization: University of Kansas Medical Center

eleavens@kumc.edu

913-945-7875

Study Officials

• Eleanor Leavens, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Phase 1 (P1): 2-visit human laboratory trial with double-blind, randomized crossover design. Phase 2 (P2): 6-week, randomized open-label substitution trial. No blinding.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 5, 2023
• Study Start: February 20, 2023
• Primary Completion: May 3, 2024
• Study Completion: June 10, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)