Assessing Electronic Cigarette Nicotine Flux

Not Applicable

Completed

• Conditions: Electronic Cigarette Use
• Interventions: Other: ECIG Lab Session, 30 watts

• Registration Number: NCT04378907
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-07
• Study Start: 2021-01-05
• Status Verified: 2023-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cigarette Smokers: 0 mg/ml nicotine concentration	ECIG Lab Session, 30 watts	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.
Cigarette Smokers: 4 mg/ml nicotine concentration	ECIG Lab Session, 30 watts	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.
Cigarette Smokers: 15 mg/ml nicotine concentration	ECIG Lab Session, 30 watts	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.
Cigarette Smokers: 30 mg/ml nicotine concentration	ECIG Lab Session, 30 watts	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.

Primary Outcome Measures

Name	Time	Method
Plasma Nicotine Concentration	Approximately 205 minutes	Change in plasma nicotine concentration Blood will be taken 5 times in each session to examine changes from baseline (approx. 90 minutes) to immediately follow a ten-puff bout (approx. 100, 120, and 190 minutes), and immediately after the cigarette challenge paradigm (approx. 205 minutes).
Cigarette Challenge Paradigm	This task will occur at approximiately 200 minutes until 205 minutes	The cigarette challenge paradigm is a procedure in which participants will be given a 5 minute time period in which they are allowed to smoke their own brand cigarette as much or as little as they want. Study staff will provide the participant with their own brand cigarettes, a lighter, and an ash tray. Latency to start the first puff and number of puffs will be recorded.

Secondary Outcome Measures

Name	Time	Method
Puff volume	Puff volume will be measured during the approximately 5-minute, 10-puff use bout.	The volume of each puff, in ml.
Puff duration	Puff duration will be measured during the approximately 5-minute, 10-puff use bout.	The duration of each puff, measured in second.

Trial Locations

Locations (1)

Center for the Study of Tobacco Products; 🇺🇸 Richmond, Virginia, United States