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The Moment Study: Mixed Method Ecigarette Study (Moment)

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

Study Description
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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.

Condition or disease
Smoking

Study Design
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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Mixed Method EMA Assessment of Cognition and Behavior Among New ENDS Users: An Observational Cohort Study
Study Start Date : August 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Groups and Cohorts
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Group/Cohort
Ecig group 1
Ecig group 2


Outcome Measures
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Primary Outcome Measures :
  1. Cigarette use [ Time Frame: Weeks 1-3 ]
    Ecological momentary assessment data through cell phone text messaging

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


Secondary Outcome Measures :
  1. Motivation to Quit [ Time Frame: 30 day follow up ]
    Stage of Change Model


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261363


Locations
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United States, District of Columbia
American Legacy Foundation
Washington, District of Columbia, United States, 20036
Sponsors and Collaborators
Truth Initiative
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jennifer Pearson, Research Investigator, Truth Initiative
ClinicalTrials.gov Identifier: NCT02261363    
Other Study ID Numbers: 00008526
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016