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

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

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2024-06-03

Brief Summary

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The goal of this application is to test whether menthol and fruit flavors impact e-cigarette use through dissociable mechanisms and exert their effects differentially across nicotine doses.

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

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Detailed Description

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This study examines the impact of menthol and fruit flavors on self-administration of e-cigarette solutions containing varying amounts of nicotine. This is a randomized, double-blind study with a within-subject cross-over design, using e-liquids with 5 different flavors and 4 different levels of nicotine for a total of 20 different e-liquid formulations. Each subject will participate in 4 test sessions. The order of flavor and nicotine delivery will be randomized. At each test session, they will undergo directed self-administration, in a randomized order, then an ad libitum self-administration session where they can choose among all of the e-cigarettes used during the directed session. The primary aims assess the impacts of nicotine and flavor (and their interactions) on participants' subjective ratings of the e-liquids during the 'directed' self-administration component, and self-administered puffs during the ad libitum self-administration component. In addition, the study will explore the impact of sex/gender and sensitivity to nicotine aversiveness or bitterness (as operationalized by genetic variations in the alpha-5 subunit of nicotinic acetylcholine receptor that influences the aversive effects of nicotine, or a taste receptor number 38 ( TAS2R38) important for bitterness perception) on study outcomes.

Conditions

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Nicotine E-liquid Flavors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a within-subject, cross-over design. Participants will be invited to complete 4 test sessions. Across those 4 test sessions, participants will self-administer e-cigarettes containing all 20 e-liquid conditions (4 nicotine \* 5 flavor conditions) in both 'directed' and ad libitum self-administration study components. The order of nicotine and flavor will be randomized across participants.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

This is a double-blind study. Although participants will receive all conditions in this within-subject cross-over study, the participant and researcher will be blinded to the order of e-liquid conditions (nicotine level, flavor) across and within test sessions.

Study Groups

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E-liquid Order 'A'

Order 'A' for E-liquid Self-Administration: All participants will be given all e-liquids (i.e., all 20 nicotine\*flavor combinations (4 nicotine\* 5 flavor combinations)) in this within-subject, cross-over design study. Participants will be randomized the order in which they self-administer the 20 nicotine\*flavor combinations of e-liquid (across and within the 4 visits). The specific order cannot be described here without disrupting the double-blind nature of the study design.

Group Type EXPERIMENTAL

Nicotine 0 mg/mL

Intervention Type DRUG

E-liquid containing no nicotine (0 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 6 mg/mL

Intervention Type DRUG

E-liquid containing low nicotine (6 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 12 mg/mL

Intervention Type DRUG

E-liquid containing medium nicotine ( 12 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 24 mg/mL

Intervention Type DRUG

E-liquid containing high nicotine ( 24 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

'Menthol' flavor

Intervention Type OTHER

E-liquid containing 'menthol' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Menthol/Mint' flavor

Intervention Type OTHER

E-liquid containing 'menthol/mint' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Green Apple' flavor

Intervention Type OTHER

E-liquid containing 'green apple' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Watermelon' flavor

Intervention Type OTHER

E-liquid containing 'watermelon' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Unflavored'

Intervention Type OTHER

E-liquid containing no additional flavor (i.e., 'unflavored') will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

E-liquid Order 'B'

Order 'B' for E-liquid Self-Administration: All participants will be given all e-liquids (i.e., all 20 nicotine\*flavor combinations (4 nicotine\* 5 flavor combinations)) in this within-subject, cross-over design study. Participants will be randomized the order in which they self-administer the 20 nicotine\*flavor combinations of e-liquid (across and within the 4 visits). The specific order cannot be described here without disrupting the double-blind nature of the study design.

Group Type EXPERIMENTAL

Nicotine 0 mg/mL

Intervention Type DRUG

E-liquid containing no nicotine (0 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 6 mg/mL

Intervention Type DRUG

E-liquid containing low nicotine (6 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 12 mg/mL

Intervention Type DRUG

E-liquid containing medium nicotine ( 12 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 24 mg/mL

Intervention Type DRUG

E-liquid containing high nicotine ( 24 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

'Menthol' flavor

Intervention Type OTHER

E-liquid containing 'menthol' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Menthol/Mint' flavor

Intervention Type OTHER

E-liquid containing 'menthol/mint' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Green Apple' flavor

Intervention Type OTHER

E-liquid containing 'green apple' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Watermelon' flavor

Intervention Type OTHER

E-liquid containing 'watermelon' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Unflavored'

Intervention Type OTHER

E-liquid containing no additional flavor (i.e., 'unflavored') will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

E-liquid Order 'C'

One nicotine level condition is a medium nicotine e-liquid (12 mg/mL nicotine). All participants will be given all e-liquids (i.e., all 20 nicotine\*flavor combinations (4 nicotine\* 5 flavor combinations)) in this within-subject, cross-over design study. Participants will be randomized the order in which they self-administer the 20 nicotine\*flavor combinations of e-liquid (across and within the 4 visits). The specific order cannot be described here without disrupting the double-blind nature of the study design.

Group Type EXPERIMENTAL

Nicotine 0 mg/mL

Intervention Type DRUG

E-liquid containing no nicotine (0 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 6 mg/mL

Intervention Type DRUG

E-liquid containing low nicotine (6 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 12 mg/mL

Intervention Type DRUG

E-liquid containing medium nicotine ( 12 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 24 mg/mL

Intervention Type DRUG

E-liquid containing high nicotine ( 24 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

'Menthol' flavor

Intervention Type OTHER

E-liquid containing 'menthol' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Menthol/Mint' flavor

Intervention Type OTHER

E-liquid containing 'menthol/mint' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Green Apple' flavor

Intervention Type OTHER

E-liquid containing 'green apple' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Watermelon' flavor

Intervention Type OTHER

E-liquid containing 'watermelon' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Unflavored'

Intervention Type OTHER

E-liquid containing no additional flavor (i.e., 'unflavored') will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

E-liquid Order 'D'

One nicotine level condition is a high nicotine e-liquid (24 mg/mL nicotine). All participants will be given all e-liquids (i.e., all 20 nicotine\*flavor combinations (4 nicotine\* 5 flavor combinations)) in this within-subject, cross-over design study. Participants will be randomized the order in which they self-administer the 20 nicotine\*flavor combinations of e-liquid (across and within the 4 visits). The specific order cannot be described here without disrupting the double-blind nature of the study design.

Group Type EXPERIMENTAL

Nicotine 0 mg/mL

Intervention Type DRUG

E-liquid containing no nicotine (0 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 6 mg/mL

Intervention Type DRUG

E-liquid containing low nicotine (6 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 12 mg/mL

Intervention Type DRUG

E-liquid containing medium nicotine ( 12 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Nicotine 24 mg/mL

Intervention Type DRUG

E-liquid containing high nicotine ( 24 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

'Menthol' flavor

Intervention Type OTHER

E-liquid containing 'menthol' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Menthol/Mint' flavor

Intervention Type OTHER

E-liquid containing 'menthol/mint' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Green Apple' flavor

Intervention Type OTHER

E-liquid containing 'green apple' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Watermelon' flavor

Intervention Type OTHER

E-liquid containing 'watermelon' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

'Unflavored'

Intervention Type OTHER

E-liquid containing no additional flavor (i.e., 'unflavored') will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

Interventions

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Nicotine 0 mg/mL

E-liquid containing no nicotine (0 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Intervention Type DRUG

Nicotine 6 mg/mL

E-liquid containing low nicotine (6 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Intervention Type DRUG

Nicotine 12 mg/mL

E-liquid containing medium nicotine ( 12 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Intervention Type DRUG

Nicotine 24 mg/mL

E-liquid containing high nicotine ( 24 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).

Intervention Type DRUG

'Menthol' flavor

E-liquid containing 'menthol' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

Intervention Type OTHER

'Menthol/Mint' flavor

E-liquid containing 'menthol/mint' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

Intervention Type OTHER

'Green Apple' flavor

E-liquid containing 'green apple' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

Intervention Type OTHER

'Watermelon' flavor

E-liquid containing 'watermelon' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

Intervention Type OTHER

'Unflavored'

E-liquid containing no additional flavor (i.e., 'unflavored') will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).

Intervention Type OTHER

Other Intervention Names

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nicotine nicotine nicotine nicotine menthol menthol fruit fruit unflavored

Eligibility Criteria

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Inclusion Criteria

* Aged 18 to 30;
* Past month daily nicotine-containing e-cigarette, cigarette, and/or cigar/little cigar/cigarillo use;
* Urine cotinine levels consistent with regular nicotine use (e.g., NicAlert urine cotinine dipstick ≥3 or Accutest Positive for Cotinine);
* For females, using acceptable birth control methods;
* Able to provide written informed consent;
* Able to read and write in English;
* Stated willingness to comply with all study procedures (including self-administration of all e-liquid conditions; attend in-person sessions; comply with COVID guidelines of the research facilities) and lifestyle considerations (including overnight nicotine abstinence) and availability for the duration of the study;
* Cardiovascular measures in normal/ non-hypertensive range for adults, including resting heart rate (HR) of 60-100 bpm; blood pressure (BP) of equal to or less than 129 mmHg (systolic)/80 mmHg (diastolic)); and oximeter (i.e., blood oxygenation) readings of 95-100 SpO2;
* Resident of the State of Connecticut.

Exclusion Criteria

* Any allergy or known hypersensitivity to propylene glycol, vegetable glycerin, menthol, mint, green apple or watermelon flavorants or history of allergic or hypersensitive reaction to use of an e-cigarette/vaping device;
* Has not used e-cigarettes at least 10 times in the last 6 months;
* For females, pregnant (as determined by pregnancy screening) or breast feeding;
* Seeking (or undergoing) treatment for nicotine dependence or tobacco product use (smoking or vaping) or has current plans to quit tobacco product use;
* Meet current criteria for psychiatric disorder (according to the MINI);
* Current or history of respiratory illnesses including pneumonia with COVID-19 , other medical illness, and/or psychotropic medication use that a clinician investigator deems a contraindication for study participation.
* History of environmental - bronchospastic allergies, multiple chemical sensitivities, or other airway sensitivities that require the use of an epi pen or that in the investigators view would make it risky for participation;
* Not fully vaccinated for COVID-19

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise DeVito, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA046360

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000025408

Identifier Type: OTHER

Identifier Source: secondary_id

2000029704

Identifier Type: -

Identifier Source: org_study_id

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Study Results

Basic Information

Brief Summary

Related Clinical Trials

Effects of Flavors on Nicotine Reinforcement in Smokers

Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1

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

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

Detailed Description

Conditions

Study Design

Study Groups

E-liquid Order 'A'

Nicotine 0 mg/mL

Nicotine 6 mg/mL

Nicotine 12 mg/mL

Nicotine 24 mg/mL

'Menthol' flavor

'Menthol/Mint' flavor

'Green Apple' flavor

'Watermelon' flavor

'Unflavored'

E-liquid Order 'B'

Nicotine 0 mg/mL

Nicotine 6 mg/mL

Nicotine 12 mg/mL

Nicotine 24 mg/mL

'Menthol' flavor

'Menthol/Mint' flavor

'Green Apple' flavor

'Watermelon' flavor

'Unflavored'

E-liquid Order 'C'

Nicotine 0 mg/mL

Nicotine 6 mg/mL

Nicotine 12 mg/mL

Nicotine 24 mg/mL

'Menthol' flavor

'Menthol/Mint' flavor

'Green Apple' flavor

'Watermelon' flavor

'Unflavored'

E-liquid Order 'D'

Nicotine 0 mg/mL

Nicotine 6 mg/mL

Nicotine 12 mg/mL

Nicotine 24 mg/mL

'Menthol' flavor

'Menthol/Mint' flavor

'Green Apple' flavor

'Watermelon' flavor

'Unflavored'

Interventions

Nicotine 0 mg/mL

Nicotine 6 mg/mL

Nicotine 12 mg/mL

Nicotine 24 mg/mL

'Menthol' flavor

'Menthol/Mint' flavor

'Green Apple' flavor

'Watermelon' flavor

'Unflavored'

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Institute on Drug Abuse (NIDA)

Yale University

Responsible Party

Principal Investigators

Elise DeVito, PhD

Locations

Yale University School of Medicine

Countries

Other Identifiers

R01DA046360

2000025408