Determination of Liquid Flavor and Nicotine Form Outcomes

Not Applicable

Completed

• Conditions: Electronic Cigarettes

• Registration Number: NCT05587504
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-20
• Study Start: 2023-07-21
• Primary Completion: 2024-07-24
• Study Completion: 2024-07-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Challenge paradigm puffs	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.
Change in plasma nicotine concentration	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.
Puff volume	Through the final product use (up to 165 min)	The volume of each puff, in ml, averaged over each product use bout.
Puff duration	Through the final product use (up to 165 min)	The duration of each puff, in ml, averaged over each product use bout.
Challenge paradigm latency	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States