Clinical Trials Directory

Trials / Completed

CompletedNCT05587504

Determination of Liquid Flavor and Nicotine Form Outcomes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Virginia Commonwealth University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERE-cigarette with sweetness type 1 and pronation level 1An "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.
OTHERE-cigarette with sweetness type 1 and pronation level 2An "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.
OTHERE-cigarette with sweetness type 2 and pronation level 1An "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.
OTHERE-cigarette with sweetness type 2 and pronation level 2An "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.

Timeline

Start date
2023-07-21
Primary completion
2024-07-24
Completion
2024-07-24
First posted
2022-10-20
Last updated
2026-02-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05587504. Inclusion in this directory is not an endorsement.