NCT04533542

Nicotine Vapor Specific Sensory Measurement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.

Detailed description

PRIMARY OBJECTIVE: I. Study that flavors might be related to the phenomenon of 'indirect' toxicity. OUTLINE: Participants are randomized to 1 of 2 conditions. CONDITION I: Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations). CONDITION II: Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).

Conditions

• Substance-Related Disorder

Interventions

Type	Name	Description
OTHER	Measurement	Undergo sensory measurements
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2021-03-10
• Primary completion: 2023-03-07
• Completion: 2023-03-07
• First posted: 2020-08-31
• Last updated: 2024-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study