Determination of Liquid Flavor and Nicotine Form Outcomes

NCT05587504 | Completed

• 2 other identifiers: HM20025474U54DA036105
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Electronic Cigarettes

Outcome Measures

Primary Outcomes (5)

• 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)

• Puff volume

  The volume of each puff, in ml, averaged over each product use bout.

  Through the final product use (up to 165 min)

• Puff duration

  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

  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

  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 Outcomes (4)

• Change in Direct Effects of Product use Questionnaires

  Baseline (approx 90 min after session start) to after final product usage (up to 185 min)

• Change in Hughes-Hatsukami Questionnaire

  Baseline (approx 90 min after session start) to after final product usage (up to 185 min)

• Change in General Labeled Magnitude Scale

  Baseline (approx 90 min after session start) to after final product usage (up to 185 min)

Study Arms (1)

Cigarette and/or e-Cigarette users

EXPERIMENTAL

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.

Other: E-cigarette with sweetness type 1 and pronation level 1; Other: E-cigarette with sweetness type 1 and pronation level 2; Other: E-cigarette with sweetness type 2 and pronation level 1; Other: E-cigarette with sweetness type 2 and pronation level 2

Interventions

E-cigarette with sweetness type 1 and pronation level 2 OTHER

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.

Cigarette and/or e-Cigarette users

E-cigarette with sweetness type 1 and pronation level 1 OTHER

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.

Cigarette and/or e-Cigarette users

E-cigarette with sweetness type 2 and pronation level 1 OTHER

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.

Cigarette and/or e-Cigarette users

E-cigarette with sweetness type 2 and pronation level 2 OTHER

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.

Cigarette and/or e-Cigarette users

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Alison Breland, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: July 21, 2023
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)