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The Moment Study: Mixed Method Ecigarette Study (Moment)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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