Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

Electronic Cigarettes Clinical Trial

Official title:

Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710590
• Other study ID #: HM20012738
• Secondary ID: U54DA036105
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: March 9, 2020

Study information

• Verified date: September 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria--participants must be:

• 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.
• Individuals who weigh less than 110 pounds 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 Cigarettes

Intervention

Other:
• ECIG Lab Session 15 watts, 10 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
• ECIG Lab Session 15 watts, 15 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).
• ECIG Lab Session 15 watts, 30 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
• ECIG Lab Session 30 watts, 10 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
• ECIG Lab Session 30 watts, 15 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
• ECIG Lab Session 30 watts, 30 mg nicotine
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	Clinical Behavioral Pharmacolgy Laboratory	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inter Puff Interval	The time between each puff, in seconds	Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period
Other	Flow Rate	The rate of air flow during each puff, in ml/second	Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period
Other	Hughes-Hatsukami Questionnaire	This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.	Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Other	Direct Effects of Product Use Questionnaire	This scale is used to assess how product use makes participants feel and consists of 10 questions that are scored 0 - 100. There are no sub-scales. Items are analyzed separately.	Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approximately 1-hour ad lib use period.
Other	Direct Effects of Nicotine Questionnaire	This scale is used to assess how product use makes participants feel, and consists of 10 questions that are scored 0 - 100.There are no sub-scales. Items are analyzed separately.	Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Other	Carbon Monoxide Levels	Change in carbon monoxide levels (in parts per mission)	Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Other	Blood Pressure	Change in blood pressure, measured in mm/hg	Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session
Other	General Labeled Magnitude Scale	This scale measures the flavor sensation, harshness, and throat hit (in three questions that correspond to those constructs) of the e-cigarette used in each session. The scale ranges from 0 - 100, with 0 being no sensation and 100 being the strongest imaginable sensation of any kind. Each item if scored nd analyzed separately (there are no sub-scales).	The General Labeled Magnitude Scale will be administered twice in each approximately 4 hour session--after a 5-minute 10 puff use bout, and after the approximately 90 minute ad lib period.
Primary	Change in Plasma Nicotine	Change in plasma nicotine level.	Baseline to 5 min after the start of a 10-puff product use
Primary	Puff Volume	The average volume of each puff, in ml, during 10 puff bout.	Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
Primary	Puff Duration	The average duration of each puff, in seconds.	Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
Secondary	Heart Rate	Average heart rate, measured in beats per minute.	Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes