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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecig group 1 | Experimental | On study day 6, we provided participants with two NJOY King 5-packs of cigalike e-cigarettes and asked them to take at least three puffs a day to ensure that they had some exposure to the product in the first week. On day 13, we gave participants two additional NJOY King 5-packs and instructed them to use or not use the e-cigarettes as they wished. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecig group 1 | Other | E-cigarettes were 3% nicotine and of tobacco or menthol flavor, depending on participants' usual flavor preference. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Use | Change in the average number of cigarettes per day comparing average cigarettes per day on study day 6 (last day of cigarette-only use) to average cigarettes per day on study day 7 (first day of e-cigarette and cigarette use). | Study Day 7, Week 2 |
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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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Legacy Foundation | Washington D.C. | District of Columbia | 20036 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29459355 | Derived | Harvey EJ, Rubin LF, Smiley SL, Zhou Y, Elmasry H, Pearson JL. Mobile Phone Ownership Is Not a Serious Barrier to Participation in Studies: Descriptive Study. JMIR Mhealth Uhealth. 2018 Feb 19;6(2):e21. doi: 10.2196/mhealth.8123. | |
| 27105716 | Derived | Pearson JL, Smiley SL, Rubin LF, Anesetti-Rothermel A, Elmasry H, Davis M, DeAtley T, Harvey E, Kirchner T, Abrams DB. The Moment Study: protocol for a mixed method observational cohort study of the Alternative Nicotine Delivery Systems (ANDS) initiation process among adult cigarette smokers. BMJ Open. 2016 Apr 22;6(4):e011717. doi: 10.1136/bmjopen-2016-011717. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ecig Group 1 | On study day 6, we provided participants with two NJOY King 5-packs of cigalike e-cigarettes (3% nicotine; tobacco or menthol flavor, depending on participants' usual flavor preference) and asked them to take at least three puffs a day to ensure that they had some exposure to the product in the first week. On day 13, we gave participants two additional NJOY King 5-packs and instructed them to use or not use the e-cigarettes as they wished. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ecig Group | This is an interventional study with one group. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | self-reported age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cigarette Use | Change in the average number of cigarettes per day comparing average cigarettes per day on study day 6 (last day of cigarette-only use) to average cigarettes per day on study day 7 (first day of e-cigarette and cigarette use). | Posted | Mean | 95% Confidence Interval | cigarettes | Study Day 7, Week 2 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ecig Group 1 | On study day 6, we provided participants with two NJOY King 5-packs of cigalike e-cigarettes (3% nicotine; tobacco or menthol flavor, depending on participants' usual flavor preference) and asked them to take at least three puffs a day to ensure that they had some exposure to the product in the first week. On day 13, we gave participants two additional NJOY King 5-packs and instructed them to use or not use the e-cigarettes as they wished. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Pearson | University of Nevada, Reno | 7756825005 | jennipearson@unr.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Menthol preference | self-reported menthol preference | Number | participants |
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| Educational attainment | self-reported education | Number | participants |
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| Fagerstrom test | Fagerstrom score is a self-reported measure of cigarette dependence. Lower scores equate to lower levels of nicotine dependence, with less than or equal to 5 equating to low dependence, 6-7 equating to moderate dependence, and 8-10 equating to high dependence. | Number | participants |
|
| Age of first cigarette | self reported age when first tried cigarettes | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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|
| 0 |
| 96 |
| 0 |
| 96 |
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