The Moment Study: Mixed Method Ecigarette Study

Smoking Clinical Trial

— Moment  

Official title:

A Mixed Method EMA Assessment of Cognition and Behavior Among New ENDS Users: An Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261363
• Other study ID #: 00008526
• Status: Completed
• Phase: N/A
• First received: October 3, 2014
• Last updated: August 18, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Truth Initiative
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking

Locations

Country	Name	City	State
United States	American Legacy Foundation	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Truth Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette use	Ecological momentary assessment data through cell phone text messaging	Weeks 1-3	No
Primary	Ecigarette use	Ecological momentary assessment data through cell phone text messaging	Weeks 1-3	No
Secondary	Motivation to Quit	Stage of Change Model	30 day follow up	No