Smoking, Tobacco Use
Conditions
Keywords
Smoking, Nicotine, Tobacco, Electronic Cigarette
Brief summary
The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.
Detailed description
Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers will be asked to provide smoking diary data, captured electronically, daily for 4 weeks. More substantive phone assessment will track smoking and related behaviors at baseline (Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag for delays in product mailing), and at +1, +3, and +6 months.
Interventions
BEHAVIORALElectronic Cigarette
An e-cigarette and four weeks of e-liquid provided to participants.
Sponsors
National Cancer Institute (NCI)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age 21+, * current smoker * regular use of email OR capacity to receive SMS text and internet access * additional smoking and health criteria determined at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| E-cig Use at End of Sampling Period | at week 4 | percentage of participants reporting using an e-cigarette |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion | Study enrollment through end of 6-month follow up | Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own |
| Smoking Cessation | at 6-month follow-up | Point prevalence abstinence from conventional smoking |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participants will not receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. | 211 |
| Sampling Participants will receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like.
Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants. | 427 |
| Total | 638 |
Baseline characteristics
| Characteristic | Control | Sampling | Total |
|---|---|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 11.9 | 42.4 years STANDARD_DEVIATION 11.2 | 42.2 years STANDARD_DEVIATION 11.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 63 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 184 Participants | 364 Participants | 548 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Motivation to Quit Smoking (0-10 scale) | 4.5 units on a scale STANDARD_DEVIATION 3.1 | 4.3 units on a scale STANDARD_DEVIATION 3.3 | 4.4 units on a scale STANDARD_DEVIATION 3.2 |
| Race/Ethnicity, Customized Black | 32 Participants | 86 Participants | 118 Participants |
| Race/Ethnicity, Customized Other | 33 Participants | 50 Participants | 83 Participants |
| Race/Ethnicity, Customized White | 146 Participants | 291 Participants | 437 Participants |
| Sex: Female, Male Female | 120 Participants | 222 Participants | 342 Participants |
| Sex: Female, Male Male | 91 Participants | 205 Participants | 296 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 211 | 0 / 427 |
| other Total, other adverse events | 98 / 211 | 177 / 427 |
| serious Total, serious adverse events | 0 / 211 | 1 / 427 |
Outcome results
Primary
E-cig Use at End of Sampling Period
percentage of participants reporting using an e-cigarette
Time frame: at week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | E-cig Use at End of Sampling Period | 13 percentage of participants |
| Sampling | E-cig Use at End of Sampling Period | 72 percentage of participants |
Secondary
Conversion
Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own
Time frame: Study enrollment through end of 6-month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Conversion | 20 percentage of participants |
| Sampling | Conversion | 19 percentage of participants |
Secondary
Smoking Cessation
Point prevalence abstinence from conventional smoking
Time frame: at 6-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Smoking Cessation | 8 percentage of participants |
| Sampling | Smoking Cessation | 14 percentage of participants |