The Moment Study: Mixed Method Ecigarette Study

Study Overview
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Brief Summary
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The universe of tobacco products is expanding, with new noncombustible products gaining popularity even as the reduction in prevalence of cigarette smoking slows or stalls. E-cigarettes, or Electronic Nicotine Delivery Systems (ENDS), are the most prevalent of these emerging noncombustible products. With sales increasing rapidly and more efficient pulmonary delivery devices under development, ENDS are likely to play an increasing role in the future tobacco market. Little is known about the cognitions and behaviors leading to or sustaining ENDS use. Smokers may use ENDS to subvert smoking restrictions, to reduce perceived smoking harms, or for smoking cessation. Evidence about ENDS use is emerging from national surveillance and laboratory research, but the majority of information on ENDS is limited to retrospective surveys and convenience samples of White male ENDS users. The investigators research suggests Black smokers are less likely than White smokers to try and be current ENDS users, perhaps due to a greater degree of perceived harm associated with ENDS, a preference for menthol, or cultural norms. Thus, it is timely and critical to study how all smokers, including Blacks and menthol smokers, experience and initiate ENDS use employing valid, innovative research methods.

Official Title
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A Mixed Method EMA Assessment of Cognition and Behavior Among New ENDS Users: An Observational Cohort Study

Conditions
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Smoking

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must: be aged 18 years or older reside in Washington, D.C. metro area (including VA and MD suburbs) be proficient in English be daily smoker with at least 5 years of established daily smoking A person will be categorized as a daily smoker if he reports daily smoking of at least 8 cigarettes a day for the past 5 years, and records an exhaled air carbon monoxide (CO) level > 8 parts-per-million (ppm) at the baseline in-person meeting. Daily smokers will be eligible for the main study if they do not intend to quit in the next 30 days. If they do intend to quit in the next 30 days, eligible daily smokers will be enrolled in the second arm of the study. not taking smoking cessation medications; smoked LCC/cigars/hookah less than 5 times in last 30 days have not used other tobacco products in last 30 days have not used an ENDS product (electronic cigarette) in the last 30 days be interested in trying an ENDS have an iPhone or Android that allows installation of applications and use it daily have a phone plan that allows unlimited text messages be willing to travel to the data collection cite four times in three weeks not be breastfeeding or planning to become pregnant not have heart disease/uncontrolled blood pressure not have psychosis/suicidal thoughts not be currently enrolled in an alcohol treatment program not be out of town for more than 5 nights in the next 6 weeks Exclusion Criteria: Individuals who do not satisfy the criteria above will not be eligible for this study. There will be no involvement of vulnerable populations.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ecig group 1<br> | |
| Ecig group 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette use | Ecological momentary assessment data through cell phone text messaging | Weeks 1-3 | 
| Ecigarette use | Ecological momentary assessment data through cell phone text messaging | Weeks 1-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation to Quit | Stage of Change Model | 30 day follow up |