Smoking
Conditions
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.
Interventions
OTHEREcig group 1
E-cigarettes were 3% nicotine and of tobacco or menthol flavor, depending on participants' usual flavor preference.
Sponsors
Truth Initiative
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Use | Study Day 7, Week 2 | Change in the average number of cigarettes per day comparing average cigarettes per day on study day 6 (last day of cigarette-only use) to average cigarettes per day on study day 7 (first day of e-cigarette and cigarette use). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ecig Group This is an interventional study with one group. | 96 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 21 |
Baseline characteristics
| Characteristic | Ecig Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants |
| Age of first cigarette <=14 years | 31 participants |
| Age of first cigarette 15-18 years | 48 participants |
| Age of first cigarette 19-24 years | 12 participants |
| Age of first cigarette 25-55 years | 5 participants |
| Educational attainment high school graduate or lower | 30 participants |
| Educational attainment some college or more | 66 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fagerstrom test <=5 | 16 participants |
| Fagerstrom test 6-7 | 57 participants |
| Fagerstrom test 8-10 | 23 participants |
| Menthol preference Menthol | 72 participants |
| Menthol preference non-menthol | 24 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 65 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 |
Outcome results
Primary
Cigarette Use
Change in the average number of cigarettes per day comparing average cigarettes per day on study day 6 (last day of cigarette-only use) to average cigarettes per day on study day 7 (first day of e-cigarette and cigarette use).
Time frame: Study Day 7, Week 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecig Group 1 | Cigarette Use | -1.82 cigarettes |