Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2014-08-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Ecig group 1
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.
Ecig group 1
E-cigarettes were 3% nicotine and of tobacco or menthol flavor, depending on participants' usual flavor preference.
Interventions
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Ecig group 1
E-cigarettes were 3% nicotine and of tobacco or menthol flavor, depending on participants' usual flavor preference.
Eligibility Criteria
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Inclusion Criteria
1. be aged 18 years or older
2. reside in Washington, D.C. metro area (including VA and MD suburbs)
3. be proficient in English
4. 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.
5. not taking smoking cessation medications;
6. smoked LCC/cigars/hookah less than 5 times in last 30 days
7. have not used other tobacco products in last 30 days
8. have not used an ENDS product (electronic cigarette) in the last 30 days
9. be interested in trying an ENDS
10. have an iPhone or Android that allows installation of applications and use it daily
11. have a phone plan that allows unlimited text messages
12. be willing to travel to the data collection cite four times in three weeks
13. not be breastfeeding or planning to become pregnant
14. not have heart disease/uncontrolled blood pressure
15. not have psychosis/suicidal thoughts
16. not be currently enrolled in an alcohol treatment program
17. not be out of town for more than 5 nights in the next 6 weeks
Exclusion Criteria
* There will be no involvement of vulnerable populations.
18 Years
ALL
Yes
Sponsors
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Truth Initiative
OTHER
Responsible Party
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Jennifer Pearson
Research Investigator
Locations
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American Legacy Foundation
Washington D.C., District of Columbia, United States
Countries
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References
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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.
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.
Other Identifiers
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00008526
Identifier Type: -
Identifier Source: org_study_id
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