Assessing Electronic Cigarette Nicotine Flux

NCT04378907 | Completed Results

• 2 other identifiers: HM200185805U54DA036105-10
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.

Conditions

Electronic Cigarette Use

Outcome Measures

Primary Outcomes (2)

• Plasma Nicotine Concentration

  Blood will be taken during each session (5) to examine changes from baseline to immediately follow a ten-puff bout. There is one arm, but 4 different conditions per outcome. One subject with/ missing plasma samples was removed from analysis.

  Before directed bout, after directed bout, prior to ad lib use, after ad lib use, and immediately after own brand use.

• Cigarette/ECIG Challenge Paradigm

  Subjects, following a period of abstinence, they are given a limited time to use either their own brand of cigarette or an e-cigarette. One arm enrolled and the subjects received each of the 4 conditions per outcome.

  Completion of ad lib bout to use of own brand cigarette

Secondary Outcomes (2)

• Puff Volume

  During directed bout, during ad lib bout

• Puff Duration

  During directed bout, during ad lib bout

Study Arms (1)

Experiemental

EXPERIMENTAL

Only one arm enrolled. ECIG Lab Session, 30 watts . During each session (intervention) participants will first complete a 10-puff product use bout, and then a 90-minute product use bout.

Other: Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration; Other: Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration; Other: Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration; Other: Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration

Interventions

Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration OTHER

ECIG LAB SESSION: 30 watts, 0 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Experiemental

Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration OTHER

ECIG Lab Session, 30 watts, 6 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Experiemental

Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration OTHER

ECIG Lab Session, 30 watts, 15 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Experiemental

Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration OTHER

ECIG Lab Session, 30 watts, 30 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Experiemental

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy (determined by self-report)
• between the ages of 18-55
• willing to provide informed consent
• able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

You may not qualify if:

• Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
• Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Virginia Commonwealth University: lead

Study Sites (1)

Center for the Study of Tobacco Products

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Results Point of Contact

• Title: Alison Breland
• Organization: Virginia Commonwealth University

abbrelan@vcu.edu

804 827 3562

Study Officials

• Alison Breland, PhD

  Virginia Commonwealth University

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations. Only one arm enrolled.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 7, 2020
• Study Start: January 5, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)