Water Content in E-Liquids

September 27, 2024 updated by: Yale University

Water Content In E-Liquids

This study looks at the effect of manipulating the water concentration of certain e-liquids on sensory perception.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study looks at the effect of manipulating water concentration on e-cigarettes that contain aldehyde flavor chemicals on sensory perception. Regular e-cigarette users will be asked to complete 2 lab sessions in which they will sample 4 nicotine containing e-liquids. Each e-liquid will be sampled in four water concentration manipulations. Researchers will examine influence of flavor and water concentrations on sensory experience including appeal/liking and irritation and harshness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • at least 21 years old
  • able to read/write
  • >/= 6 mths e-cig use
  • regular e-cig use (>/= 4 days/week)
  • use of flavored e-cigs
  • use of nicotine containing e-cigs
  • urine cotinine >/= 200ng/ml
  • no plan to quit e-cig use

Exclusion Criteria:

  • breastfeeding, pregnant, trying to become pregnant
  • Medical conditions that increase risk of respiratory problems among participants
  • Current use of illegal substances
  • Medical conditions increasing risk of respiratory problems in nonpatient populations
  • Current diagnosis of an untreated psychiatric condition
  • Not fully vaccinated for Coronavirus-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
Other: Water Concentration 1
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Other: Water Concentration 2
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Other: Water Concentration 3
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Other: Water Concentration 4
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
Experimental: Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
Other: Water Concentration 1
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Other: Water Concentration 2
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Other: Water Concentration 3
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Other: Water Concentration 4
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
Experimental: Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
Other: Water Concentration 1
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Other: Water Concentration 2
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Other: Water Concentration 3
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Other: Water Concentration 4
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
Experimental: Experimental E-Liquid Order "D"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
Other: Water Concentration 1
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Other: Water Concentration 2
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Other: Water Concentration 3
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Other: Water Concentration 4
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Irritation/Harshness
Time Frame: immediately after intervention, up to 15 minutes
Change in irritation at each water level as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).
immediately after intervention, up to 15 minutes
Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100
Time Frame: immediately after intervention, up to 15 minutes
Change in appeal at each water level as measured by the computerized Labeled Hedonic Scale (LHS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Labeled Hedonic Scale (LHS) is a bipolar category ratio scale that ranges from -100 (most disliked, minimum score) to 100 (most liked, maximum score), with 'neither liked nor disliked' as midpoint (0). Scores range from -100 (minimum) to 100 (maximum). Negative scores indicate dislike (lack of appeal) and positive scores indicate liking (appeal).
immediately after intervention, up to 15 minutes
Appeal Assessed Using the Drug Effects Questionnaire (DEQ)
Time Frame: immediately after intervention, up to 15 minutes
Change in appeal at each water level as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm).
immediately after intervention, up to 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danielle Davis, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000031495
  • 2U54DA036151-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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