Cigarette Smoking
Conditions
Keywords
Smoking cessation, Contingency management, Financial incentives, E-cigarettes, Homelessness
Brief summary
This randomized controlled trial evaluated the feasibility and potential efficacy of 1) e-cigarette switching (EC) or 2) e-cigarette switching + financial incentives for combustible cigarette cessation (EC+FI)
Detailed description
The current study examined the feasibility of e-cigarette switching and financial incentives contingent on combustible cigarette abstinence to promote combustible cigarette cessation among urban day shelter guests (N=60). A total of 60 adults who accessed the Homeless Alliance day shelter in Oklahoma City, OK were randomly assigned to 1 of 2 groups and followed weekly from 1 week prior to a scheduled EC switch date through 4 weeks post-switch date, with a final 8-week post-switch follow-up. The intervention groups were: 1) e-cigarette switching (EC) or 2) EC switching + small financial incentives for carbon monoxide (CO) verified combustible cigarette abstinence (FI + EC). The primary outcomes were self-reported combustible cigarette abstinence over the previous 7 days with carbon monoxide (CO)-verification at 4- and 8- weeks follow-up. Secondary outcomes included changes in CO from baseline, days of combustible cigarette smoking, and continued e-cigarette use. Other feasibility outcomes included study retention and perceptions of the intervention.
Interventions
BEHAVIORALE-cigarette Switching
Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.
BEHAVIORALFinancial Incentives
Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. ≥21 years of age 2. Expired CO level ≥8 ppm suggestive of current smoking 3. reported smoking ≥5 cigarettes per day 4. Willing and able to attend 8 study visits over a 10-week period 5. Interested in switching from CCs to ECs 6. Willing to abstain from smoking cannabis for the duration of the study 7. Able to speak and understand English 8. Demonstrated \>6th grade English literacy by earning a score ≥4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF), 9. Able to read a 3-sentence selection from the consent form 10. Not pregnant, breastfeeding, or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combustible Cigarette Cessation | 4 weeks post-switch date | Self-reported and Carbon monoxide-verified (\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combustible Cigarette Cessation (Complete Case Analysis) | 4 weeks post-switch | Self-reported and Carbon monoxide-verified (\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded) |
| Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline | 4 weeks post-switch | Change in expired CO (ppm) from baseline to 4 weeks post-switch-date. |
| Days of Combustible Cigarette Smoking, Past 7 Days | 4 weeks post-switch | The total number of days of combustible cigarette smoking during the past week |
| Days of E-cigarette Use, Past 7 Days | 4 weeks post-switch | The total number of days where e-cigarettes were used during the past 7 days |
| Follow-Up Completion | 4 weeks post-switch | The number of participants who completed the smoking status follow-up assessment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| E-Cigarette Switching (EC) Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.
E-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt. | 30 |
| E-cigarette Switching + Financial Incentives (EC+FI) Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.
Financial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | E-Cigarette Switching (EC) | E-cigarette Switching + Financial Incentives (EC+FI) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 28 Participants | 57 Participants |
| Age, Continuous | 50.30 Years STANDARD_DEVIATION 10.98 | 47.23 Years STANDARD_DEVIATION 10.94 | 48.77 Years STANDARD_DEVIATION 10.98 |
| Cigarettes Smoked Per Day | 15.73 Number of cigarettes smoked per day STANDARD_DEVIATION 12.13 | 16.28 Number of cigarettes smoked per day STANDARD_DEVIATION 11.08 | 16.00 Number of cigarettes smoked per day STANDARD_DEVIATION 11.53 |
| Currently Experiencing Homelessness | 24 Participants | 22 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 26 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 13 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 13 Participants | 32 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 23 Participants | 22 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Combustible Cigarette Cessation
Self-reported and Carbon monoxide-verified (\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
Time frame: 4 weeks post-switch date
Population: Participants with missing cigarette smoking status were considered smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Cigarette Switching (EC) | Combustible Cigarette Cessation | 1 Participants |
| E-cigarette Switching (EC) + Financial Incentives | Combustible Cigarette Cessation | 4 Participants |
Primary
Combustible Cigarette Cessation
Self-reported and Carbon monoxide-verified (\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
Time frame: 8 weeks post-quit/switch date
Population: Participants with missing cigarette smoking status were considered smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Cigarette Switching (EC) | Combustible Cigarette Cessation | 3 Participants |
| E-cigarette Switching (EC) + Financial Incentives | Combustible Cigarette Cessation | 4 Participants |
Secondary
Combustible Cigarette Cessation (Complete Case Analysis)
Self-reported and Carbon monoxide-verified (\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded)
Time frame: 4 weeks post-switch
Population: Participants with missing smoking status were excluded from the analyses (i.e., complete case analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Cigarette Switching (EC) | Combustible Cigarette Cessation (Complete Case Analysis) | 1 Participants |
| E-cigarette Switching (EC) + Financial Incentives | Combustible Cigarette Cessation (Complete Case Analysis) | 4 Participants |
Secondary
Combustible Cigarette Cessation (Complete Case Analysis)
Self-reported and Carbon monoxide-verified (\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded)
Time frame: 8 weeks post-switch
Population: Participants with missing smoking status data were excluded from the analyses (i.e., complete case analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Cigarette Switching (EC) | Combustible Cigarette Cessation (Complete Case Analysis) | 3 Participants |
| E-cigarette Switching (EC) + Financial Incentives | Combustible Cigarette Cessation (Complete Case Analysis) | 4 Participants |
Secondary
Days of Combustible Cigarette Smoking, Past 7 Days
The total number of days of combustible cigarette smoking during the past week
Time frame: 4 weeks post-switch
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cigarette Switching (EC) | Days of Combustible Cigarette Smoking, Past 7 Days | 4.25 Days | Standard Deviation 2.77 |
| E-cigarette Switching (EC) + Financial Incentives | Days of Combustible Cigarette Smoking, Past 7 Days | 2.20 Days | Standard Deviation 2.6 |
Secondary
Days of Combustible Cigarette Smoking, Past 7 Days
The total number of days of combustible cigarette smoking during the past 7 days
Time frame: 8 weeks post-switch
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cigarette Switching (EC) | Days of Combustible Cigarette Smoking, Past 7 Days | 2.79 Days | Standard Deviation 2.33 |
| E-cigarette Switching (EC) + Financial Incentives | Days of Combustible Cigarette Smoking, Past 7 Days | 3.73 Days | Standard Deviation 3.32 |
Secondary
Days of E-cigarette Use, Past 7 Days
The total number of days where e-cigarettes were used during the past 7 days
Time frame: 4 weeks post-switch
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cigarette Switching (EC) | Days of E-cigarette Use, Past 7 Days | 3.64 Days | Standard Deviation 2.84 |
| E-cigarette Switching (EC) + Financial Incentives | Days of E-cigarette Use, Past 7 Days | 5.07 Days | Standard Deviation 2.84 |
Secondary
Days of E-cigarette Use, Past 7 Days
The total number of days on which E-cigarettes were used during the past 7 days
Time frame: 8 weeks post-switch
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cigarette Switching (EC) | Days of E-cigarette Use, Past 7 Days | 4.15 Days | Standard Deviation 3.11 |
| E-cigarette Switching (EC) + Financial Incentives | Days of E-cigarette Use, Past 7 Days | 4.18 Days | Standard Deviation 3.25 |
Secondary
Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline
Change in expired CO (ppm) from baseline to 4 weeks post-switch-date.
Time frame: 4 weeks post-switch
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cigarette Switching (EC) | Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline | 0.31 ppm | Standard Deviation 12.1 |
| E-cigarette Switching (EC) + Financial Incentives | Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline | -8.73 ppm | Standard Deviation 7.77 |
Secondary
Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline
Change in expired CO (ppm) from baseline to 8 weeks post-switch-date
Time frame: 8 week post-switch
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cigarette Switching (EC) | Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline | -4.57 ppm | Standard Deviation 8.91 |
| E-cigarette Switching (EC) + Financial Incentives | Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline | -7.23 ppm | Standard Deviation 9.35 |
Secondary
Follow-Up Completion
The number of participants who completed the smoking status follow-up assessment
Time frame: 8 weeks post-switch
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Cigarette Switching (EC) | Follow-Up Completion | 14 Participants |
| E-cigarette Switching (EC) + Financial Incentives | Follow-Up Completion | 13 Participants |
Secondary
Follow-Up Completion
The number of participants who completed the smoking status follow-up assessment.
Time frame: 4 weeks post-switch
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Cigarette Switching (EC) | Follow-Up Completion | 16 Participants |
| E-cigarette Switching (EC) + Financial Incentives | Follow-Up Completion | 15 Participants |