Assessing Electronic Cigarette Nicotine Flux

• ClinicalTrials.gov Identifier: NCT04378907
• Recruitment Status: Completed
• First Posted: May 7, 2020
• Last Update Posted: February 6, 2023
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Electronic Cigarette Use	Other: ECIG Lab Session, 30 watts	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 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.
• Masking: Single (Participant)
• Masking Description: Participants will be blinded to the power level and nicotine concentration used in each session.
• Primary Purpose: Basic Science
• Official Title: Assessing Electronic Cigarette Nicotine Flux
• Actual Study Start Date: January 5, 2021
• Actual Primary Completion Date: February 1, 2023
• Actual Study Completion Date: February 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Plasma Nicotine Concentration [ Time Frame: 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).
2. Cigarette Challenge Paradigm [ Time Frame: 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 :

1. Puff volume [ Time Frame: Puff volume will be measured during the approximately 5-minute, 10-puff use bout. ]
   The volume of each puff, in ml.
2. Puff duration [ Time Frame: Puff duration will be measured during the approximately 5-minute, 10-puff use bout. ]
   The duration of each puff, measured in second.

Other Outcome Measures:

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Virginia

Center for the Study of Tobacco Products

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

• Study Director: Alison Breland, PhD; Virginia Commonwealth University

  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:

Informed Consent Form  [PDF] May 17, 2022

More Information

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT04378907
• Other Study ID Numbers: HM20018580
• First Posted: May 7, 2020
• Last Update Posted: February 6, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No