The Moment Study: Mixed Method E-cigarette Study

Truth Initiative

Status: Completed

Conditions: Smoking

Treatments: Other: Ecig group 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02261363

00008526

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

Ecig group 1

Experimental group

Description:

On study day 6, we provided participants with two NJOY King 5-packs of cigalike e-cigarettes and asked them to take at least three puffs a day to ensure that they had some exposure to the product in the first week. On day 13, we gave participants two additional NJOY King 5-packs and instructed them to use or not use the e-cigarettes as they wished.

Treatment:

Other: Ecig group 1