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

The Ohio State University

Status: Completed

Conditions: E-cigarette Use

Treatments: Other: ECIG lab session 6; Other: ECIG lab session 1; Other: ECIG lab session 8; Other: ECIG lab session 7; Other: ECIG lab session 4; Other: ECIG lab session 2; Other: ECIG lab session 5; Other: ECIG lab session 3

Study type: Interventional

Funder types: Other

Identifiers

NCT05458895

NCI-2021-06437 (Registry Identifier)

OSU-20313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 21 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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88 participants in 8 patient groups

High concentration free-base nicotine (5%), Tobacco flavor

Experimental group

Description:

Participate in 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.

Treatment:

Other: ECIG lab session 1

High concentration nicotine salt (5%), Tobacco flavor

Experimental group

Description:

Participate in 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.

Treatment:

Other: ECIG lab session 2

High concentration free-base nicotine (5%), Menthol flavor

Experimental group

Description:

Participate in 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.

Treatment:

Other: ECIG lab session 3

High concentration nicotine salt (5%), Menthol flavor

Experimental group

Description:

Participate in 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.

Treatment:

Other: ECIG lab session 4

Low concentration free-base nicotine (1%), Tobacco flavor

Experimental group

Description:

Participate in 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.

Treatment:

Other: ECIG lab session 5

Low concentration nicotine salt (1%), Tobacco flavor

Experimental group

Description:

Participate in 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.

Treatment:

Other: ECIG lab session 6

Low concentration free-base nicotine (1%), Menthol flavor

Experimental group

Description:

Participate in 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.

Treatment:

Other: ECIG lab session 7

Low concentration nicotine salt (1%), Menthol flavor

Experimental group

Description:

Participate in 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.

Treatment:

Other: ECIG lab session 8