Clinical trial NCT02261363: The Moment Study: Mixed Method E-cigarette Study
Official title: A Mixed Method EMA Assessment of Cognition and Behavior Among New ENDS Users: An Observational Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Truth Initiative
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Participants must:

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:

* Individuals who do not satisfy the criteria above will not be eligible for this study.
* There will be no involvement of vulnerable populations.

Primary outcomes:
measure: Cigarette Use
timeFrame: Study Day 7, Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: American Legacy Foundation
state: District of Columbia
Study officials:
References:
citation: 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.
citation: 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.