Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users
September 29, 2022 updated by: Virginia Commonwealth University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Clinical Behavioral Pharmacolgy Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Cigarette smokers
|
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
|
|
ACTIVE_COMPARATOR: Electronic cigarette users
|
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
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 |
|---|---|---|
|
Change in Plasma Nicotine
Time Frame: Baseline to 5 min after the start of a 10-puff product use
|
Change in plasma nicotine level.
|
Baseline to 5 min after the start of a 10-puff product use
|
|
Puff Volume
Time Frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
|
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
|
|
Puff Duration
Time Frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
|
The average duration of each puff, in seconds.
|
Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes
|
Average heart rate, measured in beats per minute.
|
Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inter Puff Interval
Time Frame: 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
|
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
|
|
Flow Rate
Time Frame: 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
|
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
|
|
Hughes-Hatsukami Questionnaire
Time Frame: 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.
|
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.
|
|
Direct Effects of Product Use Questionnaire
Time Frame: 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.
|
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.
|
|
Direct Effects of Nicotine Questionnaire
Time Frame: 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.
|
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.
|
|
Carbon Monoxide Levels
Time Frame: 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.
|
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.
|
|
Blood Pressure
Time Frame: Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session
|
Change in blood pressure, measured in mm/hg
|
Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session
|
|
General Labeled Magnitude Scale
Time Frame: 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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2019
Primary Completion (ACTUAL)
March 9, 2020
Study Completion (ACTUAL)
March 9, 2020
Study Registration Dates
First Submitted
October 9, 2018
First Submitted That Met QC Criteria
October 15, 2018
First Posted (ACTUAL)
October 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 6, 2022
Last Update Submitted That Met QC Criteria
September 29, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20012738
- U54DA036105 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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