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: ECIG Lab Session, 30 watts

• Study Type: Interventional
• Enrollment (Actual): 32
• 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
• Genders Eligible for Study: All

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: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cigarette Smokers: 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: ECIG Lab Session, 30 watts; During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
EXPERIMENTAL: Cigarette Smokers: 4 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: ECIG Lab Session, 30 watts; During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
EXPERIMENTAL: Cigarette Smokers: 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: ECIG Lab Session, 30 watts; During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
EXPERIMENTAL: Cigarette Smokers: 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.	Other: ECIG Lab Session, 30 watts; 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	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).	Approximately 205 minutes
Cigarette Challenge Paradigm	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.	This task will occur at approximiately 200 minutes until 205 minutes

Secondary Outcome Measures

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

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 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HM20018580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No