Nicotine Vapor Specific Sensory Measurement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-10

Study Completion Date

2023-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Consumer Assessment of Tobacco Flavor and Odor

NCT04358315

Current Vaper Healthy Subject

TERMINATED

Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes

NCT03905928

Tobacco Dependence

COMPLETED NA

Impact of Flavors on Nicotine Perception and Self-Administration Via E-cigarettes

NCT04038515

Nicotine E-liquid Flavors

COMPLETED PHASE2

Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults

NCT06816459

Cigarette Smoking-Related Carcinoma

RECRUITING EARLY_PHASE1

Sensory Perception of Sweet Flavors in E-Cigarette

NCT03332953

Smoking

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Substance-Related Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (3 video or telephone conferences)

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).

Measurement

Intervention Type OTHER

Undergo sensory measurements

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (2 video or telephone conferences)

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).

Measurement

Intervention Type OTHER

Undergo sensory measurements

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Measurement

Undergo sensory measurements

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Measure {Measure}

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Current daily vapers of products containing nicotine
* No concurrent use of other tobacco products
* Self reported general good health
* No allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures
* No self-reported taste or smell deficits
* Not pregnant or lactating
* No medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
* Passing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
* Access to video-conference or telephone
* Ability to store test products in a secure location away from children

Exclusion Criteria

* Not current daily vapers
* Concurrent use of other tobacco products
* Self-reported fair or poor general health
* Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
* Self-reported taste or smell deficits
* Pregnant or lactating
* Medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
* Failing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
* No access to video-conference or telephone
* Unable to store test products in a secure location away from children
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Adults unable to consent
* Adults unable to legally purchase tobacco products in New York (NY) state (18-20)

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes