Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)

Study Overview
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Brief Summary
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The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.

Detailed Description
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Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers will be asked to provide smoking diary data, captured electronically, daily for 4 weeks. More substantive phone assessment will track smoking and related behaviors at baseline (Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag for delays in product mailing), and at +1, +3, and +6 months.

Official Title
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Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)

Conditions
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Smoking, Tobacco Use

Intervention / Treatment
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* Behavioral: Electronic Cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 21+, current smoker regular use of email OR capacity to receive SMS text and internet access additional smoking and health criteria determined at screening

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| No Intervention: Control<br>Participants will not receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. | |
| Experimental: Sampling<br>Participants will receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. | Behavioral: Electronic Cigarette<br>* An e-cigarette and four weeks of e-liquid provided to participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E-cig Use at End of Sampling Period | percentage of participants reporting using an e-cigarette | at week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion | Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own | Study enrollment through end of 6-month follow up | 
| Smoking Cessation | Point prevalence abstinence from conventional smoking | at 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Nicotine, Tobacco, Electronic Cigarette