Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth

E-cigarette Use Clinical Trial

Official title:

Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458895
• Other study ID #: OSU-20313
• Secondary ID: NCI-2021-06437
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Toral R Mehta, PhD
• Phone: 614-753-0021
• Email: Toral.Mehta[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) "vaping", while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults ("youth"). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.

Description:

We will examine the influence of nicotine form and concentration, and e-liquid flavor on youth vaping behavior, nicotine uptake, abuse liability, toxicant exposure, and acute cardiovascular and pulmonary effects. Participants will complete 9 vaping sessions. Each vaping session will include a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. During the first session, participants will use their own e-cig and e-liquid; for the following 8 sessions, participants will vape a study-provided e-cig and e-liquid.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 25 Years

Eligibility

Inclusion Criteria:

• A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
• 21-25 years old
• Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
• Willing to complete five, 6 hour lab visits
• Able to read and speak English
• Willing to provide informed consent

Exclusion Criteria:

• Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
• Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
• History of cardiac event or distress within the past 3 months
• Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
• Use of other tobacco products > 5 days in the past month
• Current marijuana use > 5 times per month
• Currently engaging in a vaping cessation attempt
• Ohio State University (OSU) verifies study project 2 current membership/past participation

Related Conditions & MeSH terms

• E-cigarette Use

Intervention

Other:
• ECIG lab session 1
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
• ECIG lab session 2
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
• ECIG lab session 3
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
• ECIG lab session 4
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
• ECIG lab session 5
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
• ECIG lab session 6
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
• ECIG lab session 7
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
• ECIG lab session 8
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma nicotine concentration	Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.	0, 5, 10, 35 min.
Primary	Puff count	E-cig puff topography data collection for abuse liability	35 minutes
Primary	Average Puff duration	E-cig puff topography data collection for abuse liability	35 minutes
Primary	Average Puff volume	E-cig puff topography data collection for abuse liability	35 minutes
Primary	Lung function assessment	Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breathes. Measures amount inhaled and how quickly exhaled.	35 minutes
Primary	Airway Inflammation (NIOX VERO)	Physiological effects of pulmonary function collected from inhaled and exhaled breathes	35 minutes
Secondary	Sensory E-Cigarette Expectancies Scale (SEES)	Background measures. Range 0-4 from "never" to "almost always".	Baseline
Secondary	Timeline Followback (TLFB)	Background measures	Baseline
Secondary	modified Cigarette Dependence Scale	Background measures	Baseline
Secondary	Drug Effects/Liking Questionnaire	Subjective effects measures	35 minutes
Secondary	modified Cigarette Evaluation Questionnaire (mCEQ)	Subjective effects measures. Range 0-6 from "not at all" to "Extremely".	35 minutes
Secondary	E-cigarette Purchase Task	Behavioral economic demand	35 minutes
Secondary	Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form	E-cig craving/suppression of craving and withdraw	0, 5, 10, 35 min.
Secondary	Vascular reactivity	Endothelial function will be collected through EndoPAT device along with other cardiovascular measures.	30 minutes

External Links

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