Electronic Cigarette Use, Nicotine Dependence, Smoking, Cigarette
Conditions
Keywords
Tobacco Use Disorder
Brief summary
This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks). The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.
Interventions
OTHERNJOY ACE e-cigarette
Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks
Sponsors
Massachusetts General Hospital
University of Massachusetts, Boston
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label single-arm pilot clinical trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who completed the Screen Assist study (NCT03611881) and self-reported smoking cigarettes at the end of the study were asked to complete a survey to ascertain their potential interest in participating in a research study to test the effects of switching from combustible cigarettes (CC) to electronic cigarettes (EC). Individuals who expressed interest in switching to EC on that survey were screened for eligibility for this pilot study * Smoked ≥5 cigarettes/day in past month * Smoking status at study entry confirmed by breath carbon monoxide (CO) ≥ 6ppm * Willing to try switching from CC to EC for 4 weeks * Owns a mobile telephone * English speaking * Willing to travel to the Massachusetts General Hospital campus for 3 in-person visits.
Exclusion criteria
* Plans to quit smoking and has set a quit date in the next 30 days * Used smoking cessation treatment in the past 30 days * Used EC on \>2 days in the past 30 days * Hospitalized for acute coronary syndrome, unstable angina, congestive heart failure, stroke, pneumonia or chronic pulmonary disease/asthma exacerbation in the past 1 month * Not willing to abstain from smoking marijuana in the 24h before each study visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Feasibility | 4 weeks | Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation. |
| Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision | 4 weeks | Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carbon Monoxide (CO) Concentration in Expired Air | 4 weeks | Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4) |
| Cigarettes Smoked Per Day After E-cigarette Provision Ends | 4 weeks (Weeks 4-8) | Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy A. Rigotti, MD
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORJaqueline C Avila, PhD
University of Massachusetts, Boston
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NJOY ACE E-cigarette Provision Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor
Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks.
NJOY ACE e-cigarette: Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | NJOY ACE E-cigarette Provision |
|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 5.9 |
| Cigarettes Smoked Per Day | 16.9 cigarettes/day STANDARD_DEVIATION 7.2 |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 13 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 3 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision
Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4)
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NJOY ACE E-cigarette Provision | Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision | Baseline | 16.9 cigarettes/day | Standard Deviation 7 |
| NJOY ACE E-cigarette Provision | Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision | Week 4 | 10.2 cigarettes/day | Standard Deviation 7 |
Primary
Study Feasibility
Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation.
Time frame: 4 weeks
Population: The number of participants analyzed is different than the sample size as the outcome is participant enrollment among those eligible.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NJOY ACE E-cigarette Provision | Study Feasibility | 15 Participants |
Secondary
Carbon Monoxide (CO) Concentration in Expired Air
Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4)
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NJOY ACE E-cigarette Provision | Carbon Monoxide (CO) Concentration in Expired Air | Baseline | 19.4 ppm | Standard Deviation 11 |
| NJOY ACE E-cigarette Provision | Carbon Monoxide (CO) Concentration in Expired Air | Week 4 | 12.3 ppm | Standard Deviation 8.55 |
Secondary
Cigarettes Smoked Per Day After E-cigarette Provision Ends
Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8)
Time frame: 4 weeks (Weeks 4-8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NJOY ACE E-cigarette Provision | Cigarettes Smoked Per Day After E-cigarette Provision Ends | Week 4 | 10.2 cigarettes/day | Standard Deviation 7 |
| NJOY ACE E-cigarette Provision | Cigarettes Smoked Per Day After E-cigarette Provision Ends | Week 8 | 9.7 cigarettes/day | Standard Deviation 8 |