Cigarette Smoking, Electronic Cigarette Use, Smoking Cessation
Conditions
Brief summary
Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.
Detailed description
Tobacco use is a leading cause of cancer death and disability in the US, thus tobacco control remains an important public health priority. Alternative tobacco products have grown popular in the past decade, including electronic cigarettes (e-cigarettes; vaping). E-cigarettes were initially marketed as an alternative to or means for smoking cessation and became popular amongst those currently smoking. Recent estimates suggest that 54% of those who vape are currently smoking (i.e., dual use). Despite this, there is a lack of empirically tested interventions for dual use cessation among the general adult population. In a prior pilot study, investigators found preliminary evidence that a standard dose of nicotine replacement therapy (NRT; 21mg patch+4mg lozenge) was sufficient at helping exclusive e-cigarette users quit vaping. However, dual users (individuals who smoke cigarettes and use e-cigarettes) did not respond similarly. The proposed project aims to compare three doses of NRT (21mg patch+4mg lozenge; 21+14mg patch + 4mg lozenges; 21+21mg patch + 4mg lozenges) with a sample of dual users who wish to quit smoking and vaping use in order to understand more about how NRT can help dual users quit tobacco.
Interventions
DRUGRegular Nicotine patch and lozenge dose
1mg patch, qd + 4mg lozenge prn \[minimum of 5 & up to 20 per day\]
DRUGAugmented Nicotine patch and lozenge dose
21mg patch + 14mg patch qd + 4mg lozenge prn \[minimum of 5 & up to 30 per day\] OR 2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 & up to 40 per day\]
Sponsors
American Cancer Society, Inc.
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18yrs + * Daily nicotine-containing e-cigarette user (25+ days per previous month) * E-cigarette use 5+ times/day * E-cigarette use \> 1year * Smoking \>1 cigarette on 5-7 days per week * Interest in quitting smoking and e-cigarette within the next month (\>7 on 10-point scale) * Willingness to use NRT * Able to receive text messages/email * Mailing address in South Carolina.
Exclusion criteria
* Medical conditions contraindicated to NRT use (including pregnancy, past month myocardial infarction, current cardiac arrhythmia, current angina, uncontrolled vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated) * Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications * Those who vape non-nicotine substances * Individuals unable to consent (e.g. significant cognitive deficit, non-English speaking).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of Dual Use Abstinence | Day 28, Day 56 | Number of days participants self-report abstinence from both e-cigarettes and smoking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction | Day 28, Day 56 | Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment. |
| Safety (Adverse Events) | Day 28 | Adverse events and outcomes between groups will be evaluated. |
| Feasibility/Acceptability | Day 28 | Feasibility and acceptability were assessed by the proportion of eligible participants who enrolled, and among enrolled participants, the proportion who completed the Day 28 survey and the proportion who completed ≥80% of daily surveys during treatment. |
Countries
United States
Participant flow
Recruitment details
From December 2023-September 2024, 46 participants were recruited from online advertisements.
Pre-assignment details
Following consent, all females underwent a pregnancy test to ensure final eligibility for the study prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Arm A 21mg patch, qd + 4mg lozenge prn \[minimum of 5 & up to 20 per day\] | 16 |
| Arm B 21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 & \[up to 30 per day\] | 15 |
| Arm C 2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 & up to 40 per day\] | 15 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 1-month Follow-up | Lost to Follow-up | 0 | 1 | 1 |
| 28-Day Treatment | Lost to Follow-up | 7 | 3 | 4 |
Baseline characteristics
| Characteristic | Arm B | Arm C | Arm A | Total |
|---|---|---|---|---|
| Age, Continuous | 39.3 Years STANDARD_DEVIATION 11.8 | 36.0 Years STANDARD_DEVIATION 11.1 | 38.1 Years STANDARD_DEVIATION 7.7 | 37.8 Years STANDARD_DEVIATION 10.1 |
| Dependence High | 13 Participants | 13 Participants | 14 Participants | 40 Participants |
| Dependence Low | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 14 Participants | 14 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 13 Participants | 14 Participants | 38 Participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 4 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 9 / 16 | 13 / 15 | 10 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Days of Dual Use Abstinence
Number of days participants self-report abstinence from both e-cigarettes and smoking.
Time frame: Day 28, Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | Days of Dual Use Abstinence | Dual Abstinence Days 1-28 | 3.8 Days | Standard Deviation 7.8 |
| Arm A | Days of Dual Use Abstinence | Dual Abstinence Days 1-56 | 4.6 Days | Standard Deviation 8.3 |
| Arm B | Days of Dual Use Abstinence | Dual Abstinence Days 1-28 | 11.2 Days | Standard Deviation 8.7 |
| Arm B | Days of Dual Use Abstinence | Dual Abstinence Days 1-56 | 23.8 Days | Standard Deviation 20.9 |
| Arm C | Days of Dual Use Abstinence | Dual Abstinence Days 1-28 | 6.9 Days | Standard Deviation 10.3 |
| Arm C | Days of Dual Use Abstinence | Dual Abstinence Days 1-56 | 16.1 Days | Standard Deviation 21.4 |
Secondary
Feasibility/Acceptability
Feasibility and acceptability were assessed by the proportion of eligible participants who enrolled, and among enrolled participants, the proportion who completed the Day 28 survey and the proportion who completed ≥80% of daily surveys during treatment.
Time frame: Day 28
Population: Participants in the 'Eligible and Contacted' arm were only assessed for enrollment; survey completion was not measured. Participants in the 'Enrolled' arm were only assessed for survey completion; enrollment was not measured. Therefore, some rows have zero analyzed counts because those measures were not applicable to that arm.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm A | Feasibility/Acceptability | Eligible & Contacted | Completed Day 28 Survey | 0 Participants |
| Arm A | Feasibility/Acceptability | Enrolled | Enrolled | 0 Participants |
| Arm A | Feasibility/Acceptability | Eligible & Contacted | Enrolled | 46 Participants |
| Arm A | Feasibility/Acceptability | Eligible & Contacted | Completed >=80% of Daily Surveys | 0 Participants |
| Arm A | Feasibility/Acceptability | Enrolled | Completed >=80% of Daily Surveys | 0 Participants |
| Arm A | Feasibility/Acceptability | Enrolled | Completed Day 28 Survey | 0 Participants |
| Arm B | Feasibility/Acceptability | Enrolled | Completed >=80% of Daily Surveys | 12 Participants |
| Arm B | Feasibility/Acceptability | Eligible & Contacted | Enrolled | 0 Participants |
| Arm B | Feasibility/Acceptability | Eligible & Contacted | Completed Day 28 Survey | 0 Participants |
| Arm B | Feasibility/Acceptability | Eligible & Contacted | Completed >=80% of Daily Surveys | 0 Participants |
| Arm B | Feasibility/Acceptability | Enrolled | Enrolled | 0 Participants |
| Arm B | Feasibility/Acceptability | Enrolled | Completed Day 28 Survey | 25 Participants |
Secondary
Reduction
Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment.
Time frame: Day 28, Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | Reduction | Reduction in Days of E-cigarette Use Before and During Treatment (Days 1-28) | 6.1 Days | Standard Deviation 10.5 |
| Arm A | Reduction | Reduction in Days of Cigarette Use Before and During Treatment (Days 1-28) | 7.9 Days | Standard Deviation 13.2 |
| Arm A | Reduction | Reduction in Days of E-Cigarette Use Before and After Treatment (Days 29-56) | 3.2 Days | Standard Deviation 8.6 |
| Arm A | Reduction | Reduction in Cigarette Use Before and After Treatment (Days 29-56) | 8.2 Days | Standard Deviation 15.2 |
| Arm B | Reduction | Reduction in Cigarette Use Before and After Treatment (Days 29-56) | 19.5 Days | Standard Deviation 13 |
| Arm B | Reduction | Reduction in Days of E-cigarette Use Before and During Treatment (Days 1-28) | 13.5 Days | Standard Deviation 10.7 |
| Arm B | Reduction | Reduction in Days of E-Cigarette Use Before and After Treatment (Days 29-56) | 12.5 Days | Standard Deviation 15 |
| Arm B | Reduction | Reduction in Days of Cigarette Use Before and During Treatment (Days 1-28) | 16.4 Days | Standard Deviation 10.3 |
| Arm C | Reduction | Reduction in Cigarette Use Before and After Treatment (Days 29-56) | 12.4 Days | Standard Deviation 13.9 |
| Arm C | Reduction | Reduction in Days of Cigarette Use Before and During Treatment (Days 1-28) | 12.2 Days | Standard Deviation 12.9 |
| Arm C | Reduction | Reduction in Days of E-Cigarette Use Before and After Treatment (Days 29-56) | 9.3 Days | Standard Deviation 13.6 |
| Arm C | Reduction | Reduction in Days of E-cigarette Use Before and During Treatment (Days 1-28) | 9.5 Days | Standard Deviation 11 |
Secondary
Safety (Adverse Events)
Adverse events and outcomes between groups will be evaluated.
Time frame: Day 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A | Safety (Adverse Events) | Any Severe Adverse Event (self-reported severity rating) | 0 Participants |
| Arm A | Safety (Adverse Events) | Any Adverse Event | 9 Participants |
| Arm A | Safety (Adverse Events) | Any Doctor/Clinic/Hospital Visit due to Adverse Event | 0 Participants |
| Arm B | Safety (Adverse Events) | Any Severe Adverse Event (self-reported severity rating) | 1 Participants |
| Arm B | Safety (Adverse Events) | Any Adverse Event | 13 Participants |
| Arm B | Safety (Adverse Events) | Any Doctor/Clinic/Hospital Visit due to Adverse Event | 0 Participants |
| Arm C | Safety (Adverse Events) | Any Adverse Event | 10 Participants |
| Arm C | Safety (Adverse Events) | Any Doctor/Clinic/Hospital Visit due to Adverse Event | 0 Participants |
| Arm C | Safety (Adverse Events) | Any Severe Adverse Event (self-reported severity rating) | 0 Participants |