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History of Changes for Study: NCT02261363
The Moment Study: Mixed Method Ecigarette Study (Moment)
Latest version (submitted August 18, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 9, 2014 None (earliest Version on record)
2 November 3, 2014 Study Status and Eligibility
3 June 29, 2015 Study Status
4 August 10, 2015 Eligibility, Groups and Interventions and Study Status
5 November 30, 2015 Study Status and Study Identification
6 August 18, 2016 Recruitment Status, Study Status, Contacts/Locations, Study Design
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Study NCT02261363
Submitted Date:  October 9, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 00008526
Brief Title: The Moment Study: Mixed Method Ecigarette Study (Moment)
Official Title: A Mixed Method EMA Assessment of Cognition and Behavior Among New ENDS Users: An Observational Cohort Study
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2014
Overall Status: Recruiting
Study Start: August 2014
Primary Completion: March 2015 [Anticipated]
Study Completion:
First Submitted: October 3, 2014
First Submitted that
Met QC Criteria:
October 9, 2014
First Posted: October 10, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 9, 2014
Last Update Posted: October 10, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Truth Initiative
Responsible Party: Principal Investigator
Investigator: Jennifer Pearson
Official Title: Research Investigator
Affiliation: Truth Initiative
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Smoking
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 120 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Cessation Group
Non-Cessation Group
Open or close this module Outcome Measures
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
Open or close this module Eligibility
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 140 daily smokers (or 100 study completers) with equal representation of menthol and non-menthol smokers, and stratify by race such that our final sample will include 25 Black menthol, 25 White menthol, 25 Black non-menthol, and 25 White non-menthol smokers (Figure 1). For the second study arm, we will enroll an additional 30 participants, with the goal of 20 individual completing the protocol. 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.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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 use other tobacco products in last 30 days
  8. have never tried an ENDS
  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. have regular work hours
  18. 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.
Open or close this module Contacts/Locations
Central Contact Person: Jennifer Pearson, PhD, MPH
Telephone: 202-454-5768
Email: jpearson@legacyforhealth.org
Central Contact Backup: Sabrina Smiley, PhD
Email: ssmiley@legacyforhealth.org
Locations: United States, District of Columbia
American Legacy Foundation
[Recruiting]
Washington, District of Columbia, United States, 20036
Contact:Contact: Jennifer Pearson, PhD, MPH 202-454-5768 jpearson@legacyforhealth.org
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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