The Moment Study: Mixed Method Ecigarette Study (Moment)

• ClinicalTrials.gov Identifier: NCT02261363
• Recruitment Status: Completed
• First Posted: October 10, 2014
• Last Update Posted: August 22, 2016
• Sponsor: Truth Initiative
• Information provided by (Responsible Party): Jennifer Pearson, Truth Initiative

Tracking Information

• First Submitted Date: October 3, 2014
• First Posted Date: October 10, 2014
• Last Update Posted Date: August 22, 2016
• Study Start Date: August 2014
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 9, 2014)

• Cigarette use [ Time Frame: Weeks 1-3 ]
  Ecological momentary assessment data through cell phone text messaging
• Ecigarette use [ Time Frame: Weeks 1-3 ]
  Ecological momentary assessment data through cell phone text messaging

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 9, 2014)

Motivation to Quit [ Time Frame: 30 day follow up ]

Stage of Change Model

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Moment Study: Mixed Method Ecigarette Study
• Official Title: A Mixed Method EMA Assessment of Cognition and Behavior Among New ENDS Users: An Observational Cohort Study
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: In total, our goal is to enroll 150 individuals, with 120 participants completing the protocol. For the main arm of the study, we will recruit a racially and ethnically diverse sample of 140 daily smokers (or 100 study completers), with the goal of recruiting at least 50% non-Hispanic black participants. For the second study arm, we will enroll an additional 30 participants, with the goal of 20 individuals completing the protocol. There are no race/ethnicity recruitment goals associated with the second arm. In total, the main study arm will consist of 100 daily smokers who do not intend to quit smoking in the next 30 days, while the second arm will include 20 daily smokers who do intend to quit smoking in the next 30 days.
• Condition: Smoking
• Intervention: Not Provided

Study Groups/Cohorts

• Ecig group 1
• Ecig group 2

Publications *

• 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. Erratum In: JMIR Mhealth Uhealth. 2018 Mar 19;6(3):e10403.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 18, 2016): 117
• Original Estimated Enrollment (submitted: October 9, 2014): 120
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02261363
• Other Study ID Numbers: 00008526
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jennifer Pearson, Truth Initiative
• Original Responsible Party: Same as current
• Current Study Sponsor: Truth Initiative
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Truth Initiative
• Verification Date: August 2016