Quit or Switch: E-cigarette Study

Study Overview
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Brief Summary
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The majority of smokers try to quit each year, and the majority of quit attempts fail, even when the most effective FDA-approved pharmacotherapies are used. Non-combustible tobacco products emit fewer harmful chemicals than cigarettes, and thus for smokers who cannot quit smoking, switching completely to a less harmful product is likely to improve their risk of cancer and other deleterious health outcomes. E-cigarettes, the most commonly used non-cigarette tobacco product, have been shown to deliver sufficient nicotine, be appealing to smokers, and reduce cigarette smoking when provided to smokers to use ad libitum. For smokers who have failed to quit with traditional methods, trying to switch to a less harmful product may be more likely to help them stop smoking than trying to quit using tobacco altogether repeatedly with pharmacotherapy. The proposed trial evaluates the potential of e-cigarettes to serve as harm reduction tools for current smokers who have already tried, and failed, to quit with traditional methods. Current smokers who failed to quit with FDA-approved pharmacotherapy within the past year (N=30) will be randomly assigned to either 1) switch completely to e-cigarettes (Switch Group, n=20), or 2) try to quit again using pharmacotherapy (Meds Group, n=10). Thus, our design is strengthened by a strong active control group. Participants will select a Target Switch / Quit Date on which they will stop smoking. Participants in the Switch group will receive a 5-week supply of JUUL e-cigarettes, the most popular e-cigarette currently available. Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Participants will use 1-week of their tobacco product or medication ad libitum while continuing to smoke in advance of their Target Switch / Quit Date, and 4-weeks as instructed following a Target Switch or Quit Date. Behavioral outcomes of interest include smoking reduction > 50% and biochemically-confirmed abstinence from cigarette smoking at 4-weeks. The proposed trial addresses a highly significant research question using a rigorous design and is supported by a strong investigative team.

Official Title
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E-cigarettes as Harm Reduction Tools in Smokers Who Fail to Quit With Traditional Methods

Conditions
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Tobacco Use

Intervention / Treatment
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* Behavioral: e-cigarette
* Other: Nicotine patch, Nicotine lozenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years old Smoking at least 5 cigarettes per day for 1 year A quit attempt using an FDA-approved pharmacotherapy in the past year that resulted in abstinence of at least 24 hours Intention to quit smoking within the next month Access to daily e-mail or a smartphone that receives text messages Exclusion Criteria: use of non-cigarette tobacco products in the past 30 days current use of pharmacotherapy for smoking cessation pregnant, breastfeeding, or trying to become pregnant household member currently enrolled in the study contraindicated for NRT planning to move out of the area within the next 6 months.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Switch Group<br>Participants in the Switch group will receive a 5-week supply of e-cigarettes. | Behavioral: e-cigarette<br>* Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.<br>|
| Active Comparator: Meds Group<br>Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). | Other: Nicotine patch, Nicotine lozenge<br>* Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who report daily use of e-cigarettes or NRT and no cigarette use | daily use of e-cigarette or NRT instead of cigarettes | day 0 through day 35 | 
| Percentage of participants who have biochemically-confirmed abstinence from cigarette smoking | CO | day 0 through day 35 |