Assessing Electronic Cigarette Nicotine Flux

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use
• Intervention / Treatment: 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

Detailed Description

Only one arm enrolled.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Center for the Study of Tobacco Products

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experiemental; 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; 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.; Other: Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration; 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.; Other: Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration; 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.; Other: Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puff Volume	Puff volume.	During directed bout, during ad lib bout
Puff Duration	Puff duration measured in seconds.	During directed bout, during ad lib bout

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Change in heart rate, measured in beats per minute.	Baseline to 255 minutes
Inter puff interval	The time between each puff, in seconds.	Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout.
Flow rate	The rate of air flow during each puff, in ml/second.	Flow rate will be measured during the approximately 5-minute, 10-puff use bout.
Direct Effects of Vaping Questionnaire	This measure is related to the effects of vaping (10 questions, each scored from 0 - 100).	This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
Direct Effects of Nicotine Questionnaire	This measure is related to the side effects of nicotine (10 questions, each scored from 0 - 100).	This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
Hughes-Hatsukami Questionnaire	This measure is related to nicotine abstinence symptoms (11 questions, each scored from 0 - 100).	This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
General Labeled Magnitude Scale	This measure is related to perceptions of electronic cigarette effects (3 questions, each scored from 0 - 100).	This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
Labeled Hedonic Scale	This measure is related to perceptions of electronic cigarette effects (4 questions, each scored from 0 - 100).	This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Study Director: Alison Breland, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Vaping
• Other Study ID Numbers: HM20018580; 5U54DA036105-10 (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: No