Clinical trial NCT05587504: Determination of Liquid Flavor and Nicotine Form Outcomes
Official title: Determination of Liquid Flavor and Nicotine Form Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarettes
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-10-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: Each participant will participate in 5 sessions. Sessions differ by the tobacco product used (see study arms). The sessions will be ordered by latin-square; however, session order is NOT expected to change any outcomes and order effects are not relevant to the study.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in plasma nicotine concentration
timeFrame: Baseline (approx 90 min after session start) to after final product usage (up to 165 min)
measure: Puff volume
timeFrame: Through the final product use (up to 165 min)
measure: Puff duration
timeFrame: Through the final product use (up to 165 min)
measure: Challenge paradigm latency
timeFrame: at the end of the challenge paradigm, approx. 165 min
measure: Challenge paradigm puffs
timeFrame: at the end of the challenge paradigm, approx. 165 min
Secondary outcomes:
Other outcomes:
measure: Change in Direct Effects of Product use Questionnaires
timeFrame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
measure: Change in Hughes-Hatsukami Questionnaire
timeFrame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
measure: Change in General Labeled Magnitude Scale
timeFrame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
measure: Change in Labeled Hedonic Scale
timeFrame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alison Breland, PhD
role: PRINCIPAL_INVESTIGATOR
References: