Determination of Liquid Flavor and Nicotine Form Outcomes

Electronic Cigarettes Clinical Trial

Official title:

Determination of Liquid Flavor and Nicotine Form Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587504
• Other study ID #: HM20025474
• Secondary ID: U54DA036105
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Virginia Commonwealth University
• Contact: Alison Breland, PhD
• Phone: 804 628 2300
• Email: abbrelan[@]vcu.edu
• 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 cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel.

Description:

In this study, participants will be asked to do the following:

1. After an initial screening visit, visit the Center for the Study of Tobacco Products 4 more times for approximately 3-hour study visits.

2. Before each visit, abstain from all tobacco products (cigarettes, e-cigarettes/vapes, cigars, and hookah/waterpipe) for at least 12 hours.

3. 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).

4. During each session, participants will respond to several questionnaires to measure how they feel before and after they use an e-cigarette.

5. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electronic Cigarettes

Intervention

Other:
• E-cigarette with sweetness type 1 and pronation 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 1.
• E-cigarette with sweetness type 1 and pronation 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 1 and protonation level 2.
• E-cigarette with sweetness type 2 and pronation 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 1.
• E-cigarette with sweetness type 2 and pronation 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 2.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	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	Change in Direct Effects of Product use Questionnaires	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)
Other	Change in Hughes-Hatsukami Questionnaire	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)
Other	Change in General Labeled Magnitude Scale	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)
Other	Change in Labeled Hedonic Scale	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)
Primary	Change in plasma nicotine concentration	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)
Primary	Puff volume	The volume of each puff, in ml, averaged over each product use bout.	Through the final product use (up to 165 min)
Primary	Puff duration	The duration of each puff, in ml, averaged over each product use bout.	Through the final product use (up to 165 min)
Primary	Challenge paradigm latency	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
Primary	Challenge paradigm puffs	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