Assessing Electronic Cigarette Nicotine Flux

Electronic Cigarette Use Clinical Trial

Official title:

Assessing Electronic Cigarette Nicotine Flux

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378907
• Other study ID #: HM20018580
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electronic Cigarette Use

Intervention

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.

Locations

Country	Name	City	State
United States	Center for the Study of Tobacco Products	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in heart rate	Change in heart rate, measured in beats per minute.	Baseline to 255 minutes
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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
Primary	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	Puff volume	The volume of each puff, in ml.	Puff volume will be measured during the approximately 5-minute, 10-puff use bout.
Secondary	Puff duration	The duration of each puff, measured in second.	Puff duration will be measured during the approximately 5-minute, 10-puff use bout.