Determination of Liquid Flavor and Nicotine Form Outcomes
Study Overview
Status
Conditions
Detailed Description
In this study, participants will be asked to do the following:
- After an initial screening visit, visit the Center for the Study of Tobacco Products 4 more times for approximately 3-hour study visits.
- Before each visit, abstain from all tobacco products (cigarettes, e-cigarettes/vapes, cigars, and hookah/waterpipe) for at least 12 hours.
- Allow researcher to take blood pressure readings (with blood pressure cuff on their arm) monitor their heart rate (with a device that attaches to their finger), and allow a nurse to insert an IV catheter into their arm that will stay there for the entire session. This catheter will be used to draw blood periodically (less than 1 tablespoon per sample, 5 samples per visit).
- During each session, participants will respond to several questionnaires to measure how they feel before and after they use an e-cigarette.
- In each session, use an electronic cigarette provided by the study team at two separate times. After using the e-cigarette two times, participants will be offered the opportunity to use their own e-cigarette or cigarette.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy (determined by self-report)
- between the ages of 18-65
- willing to provide informed consent
- use cigarettes, e-cigarettes, or both
- 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
- existence of any condition contraindicated for this study protocol as determined by study leadership
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cigarette and/or e-Cigarette users
Each participant will participate in 4 sessions.
During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm.
|
An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 1.
An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 2.
An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 1.
An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plasma nicotine concentration
Time Frame: Baseline (approx 90 min after session start) to after final product usage (up to 165 min)
|
Blood will be taken multiple times in each session to examine changes in plasma nicotine concentration from baseline to after various e-cigarette or cigarette usage.
|
Baseline (approx 90 min after session start) to after final product usage (up to 165 min)
|
|
Puff volume
Time Frame: Through the final product use (up to 165 min)
|
The volume of each puff, in ml, averaged over each product use bout.
|
Through the final product use (up to 165 min)
|
|
Puff duration
Time Frame: Through the final product use (up to 165 min)
|
The duration of each puff, in ml, averaged over each product use bout.
|
Through the final product use (up to 165 min)
|
|
Challenge paradigm latency
Time Frame: at the end of the challenge paradigm, approx. 165 min
|
The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette.
Researchers measure the time it takes for the participant to pick up the product.
|
at the end of the challenge paradigm, approx. 165 min
|
|
Challenge paradigm puffs
Time Frame: at the end of the challenge paradigm, approx. 165 min
|
The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette.
Researchers measure the number of puffs the participant takes.
|
at the end of the challenge paradigm, approx. 165 min
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Direct Effects of Product use Questionnaires
Time Frame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
|
Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage. This scale is used to assess how product use makes participants feel and consists of 10 questions each for e-cigarettes and cigarettes that are scored 0 - 100. There are no sub-scales. Items are analyzed separately. |
Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
|
|
Change in Hughes-Hatsukami Questionnaire
Time Frame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
|
Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage. This scale will be 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. |
Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
|
|
Change in General Labeled Magnitude Scale
Time Frame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
|
Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage. 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 is scored and analyzed separately (there are no sub-scales). |
Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
|
|
Change in Labeled Hedonic Scale
Time Frame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
|
Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage. This measure is related to perceptions of electronic cigarette effects (4 questions, each scored from 0 - 100). |
Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alison Breland, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20025474
- U54DA036105 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.