Water Content in E-Liquids

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Water Content In E-Liquids

ClinicalTrials.gov ID

NCT05257109

Acronym / sponsor ID

2000031495

Conditions

Nicotine E-Cigarette Use

Study type

Interventional

Recruitment status

Completed

Enrolment

31 participants (actual)

Lead sponsor

Yale UniversityUniversity, hospital or other

Collaborators

National Institute on Drug Abuse (NIDA)

Study start

1 Aug 2022 (actual)

Primary completion

10 Mar 2023 (actual)

Study completion

10 Mar 2023 (actual)

First posted

25 Feb 2022 (actual)

Results

Posted 22 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Other

Allocation

Randomised

Intervention model

Crossover

Masking

Double blind (participant, investigator)

Number of arms

4

Model description

Within subject design, all participants will receive all e-liquid flavors/water concentrations

Who may qualify

Ages

21 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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).

2. 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).

3. 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).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 42161504Davis D, Green BG, Krishnan-Sarin S, Martin TD, Wu R, Gueorguieva R, Anastas PT, Zimmerman JB, O'Malley S, Allen W, Erythropel HC. Water addition to e-liquids to reduce flavour aldehyde acetal formation: chemistry and user sensory experience and appeal. Tob Control. 2026 May 20:tc-2025-060013. doi: 10.1136/tc-2025-060013. Online ahead of print.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.