Sex Differences in E-cig Perception: Study 1

NCT ID: NCT05432830

Last Updated: 2026-01-28

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-07-18

Brief Summary

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The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.

Detailed Description

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This study looks at the effect of sex on the sensory effects of flavor components in e-cigarettes. Regular combustible tobacco users will sample 3 different flavored e-cigarettes containing nicotine in a human lab paradigm.

Conditions

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Nicotine Addiction E-Cig Use Cigarette Smoking Sex Differences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Within subject design, all participants will receive all flavors
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double blind, both participant and investigator will be blind to e-liquid being administered

Study Groups

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Experimental E-Liquid Order "A"

All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).

Group Type EXPERIMENTAL

E-liquid Flavor 1

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.

E-liquid Flavor 2

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.

E-liquid Flavor 3

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.

Experimental E-Liquid Order "B"

All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).

Group Type EXPERIMENTAL

E-liquid Flavor 1

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.

E-liquid Flavor 2

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.

E-liquid Flavor 3

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.

Experimental E-Liquid Order "C"

All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).

Group Type EXPERIMENTAL

E-liquid Flavor 1

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.

E-liquid Flavor 2

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.

E-liquid Flavor 3

Intervention Type OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.

Interventions

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E-liquid Flavor 1

E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.

Intervention Type OTHER

E-liquid Flavor 2

E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.

Intervention Type OTHER

E-liquid Flavor 3

E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 21-44 years old
* Able to read/write
* Current cigarette smoking
* Recent E-cig Exposure (\>/= 10 uses in past 6 mo.)
* Urine cot \>200ng/ml
* Willing to abstain from nicotine/tobacco 6-8hrs prior to lab session
* Not looking to quit

Exclusion Criteria

* Untreated chronic medical conditions
* Non-stable Rx medication
* Illicit drug use
* Pregnant, trying to become pregnant, breastfeeding
* Not fully vaccinated for Coronavirus (e.g. COVID-19)
Minimum Eligible Age

21 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle Davis

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1K01DA056494-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000032981

Identifier Type: -

Identifier Source: org_study_id

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