A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior

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

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2028-04-12

Brief Summary

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This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked.

II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence.

III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

ARM III: Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

Participants in all arms participate in discussions throughout the trial.

SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm I (PEC)

Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Vaping

Intervention Type DEVICE

Given Preferred Flavor e-liquid

Arm II (TEC)

Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Vaping

Intervention Type DEVICE

Given Tobacco flavored e-liquid

Arm III (NRT)

Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.

Group Type ACTIVE_COMPARATOR

Nicotine Replacement

Intervention Type DRUG

Given nicotine patches and nicotine lozenges

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Nicotine Replacement

Given nicotine patches and nicotine lozenges

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Vaping

Given Preferred Flavor e-liquid

Intervention Type DEVICE

Vaping

Given Tobacco flavored e-liquid

Intervention Type DEVICE

Other Intervention Names

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Nicotine Replacement Therapy NRT Vape Vape

Eligibility Criteria

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Inclusion Criteria

* \>= 21 years old
* Smoke \>= 5 cigarettes per day for the past year
* Willing to use either an EC or NRT
* Read and speak English
* Have a smartphone

Exclusion Criteria

* Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
* Current use of an EC \> 4 days a month
* Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
* Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
* History of cardiac event or distress within the past 3 months
* Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
* High blood pressure not controlled by medications
* Serious angina pectoris or chest pain
* Stroke within the past three months
* Known allergy to propylene glycol or vegetable glycerin
* Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
* Live in same household as another study participant

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes