Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Cigarette Switching (EC) | Experimental | Participants were provided with an e-cigarette device and nicotine pods and advised to completely switch from combustible cigarettes to e-cigarettes. Although participants in the EC group did not earn incentives for combustible cigarette abstinence, they were yoked with a participant in the EC+FI group (described below), and they earned the same weekly incentive amount as their counterpart earned for combustible cigarette abstinence credited to a reloadable study credit card. |
|
| E-Cigarette Switching + Financial Incentives (EC+FI) | Experimental | Participants assigned to the EC+FI group received ECs and pods and were instructed to switch from combustible cigarettes to e-cigarettes as described above for the EC group. Participants also earned escalating financial incentives for self-reported and carbon-monoxide-verified combustible cigarette abstinence via credits to a reloadable study credit card. Participants who reported combustible cigarette use and/or had a CO level >6 ppm did not earn incentives that week, but could earn incentives at the next visit with the incentive value reset to the starting value. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette Switching | Behavioral | Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combustible Cigarette Cessation | Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking) | 4 weeks post-switch date |
| Combustible Cigarette Cessation | Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking) | 8 weeks post-quit/switch date |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 weeks post-switch |
| Combustible Cigarette Cessation (Complete Case Analysis) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Darla E. Kendzor, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Homeless Alliance | Oklahoma City | Oklahoma | 73106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36844157 | Background | Boozary LK, Frank-Pearce SG, Alexander AC, Sifat MS, Kurien J, Waring JJC, Ehlke SJ, Businelle MS, Ahluwalia JS, Kendzor DE. Tobacco use characteristics, treatment preferences, and motivation to quit among adults accessing a day shelter in Oklahoma City. Drug Alcohol Depend Rep. 2022 Nov 5;5:100117. doi: 10.1016/j.dadr.2022.100117. eCollection 2022 Dec. | |
| 39764385 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Financial Incentives + E-cigarette Switching | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Combustible Cigarette Cessation | Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking) | Participants with missing cigarette smoking status were considered smoking. | Posted | Count of Participants | Participants | 4 weeks post-switch date |
|
Approximately 10 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darla E. Kendzor | The University of Oklahoma Health Sciences | (405) 271-7848 | Darla-Kendzor@ouhsc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2022 | May 9, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D016540 | Smoking Cessation |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Financial Incentives | Behavioral | Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence. |
|
|
Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded) |
| 8 weeks post-switch |
| Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline | Change in expired CO (ppm) from baseline to 4 weeks post-switch-date. | 4 weeks post-switch |
| Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline | Change in expired CO (ppm) from baseline to 8 weeks post-switch-date | 8 week post-switch |
| Days of Combustible Cigarette Smoking, Past 7 Days | The total number of days of combustible cigarette smoking during the past week | 4 weeks post-switch |
| Days of Combustible Cigarette Smoking, Past 7 Days | The total number of days of combustible cigarette smoking during the past 7 days | 8 weeks post-switch |
| Days of E-cigarette Use, Past 7 Days | The total number of days where e-cigarettes were used during the past 7 days | 4 weeks post-switch |
| Days of E-cigarette Use, Past 7 Days | The total number of days on which E-cigarettes were used during the past 7 days | 8 weeks post-switch |
| Follow-Up Completion | The number of participants who completed the smoking status follow-up assessment. | 4 weeks post-switch |
| Follow-Up Completion | The number of participants who completed the smoking status follow-up assessment | 8 weeks post-switch |
| Sifat MS, Alexander AC, Businelle MS, Frank-Pearce SG, Boozary LK, Wagener TL, Ahluwalia JS, Kendzor DE. E-Cigarette switching and financial incentives to promote combustible cigarette cessation among adults accessing shelter services: A pilot study. Drug Alcohol Depend Rep. 2024 Nov 6;13:100295. doi: 10.1016/j.dadr.2024.100295. eCollection 2024 Dec. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Currently Experiencing Homelessness | Count of Participants | Participants |
|
| Cigarettes Smoked Per Day | 1 participant excluded from analyses because of out of range value (i.e., 2400 cigarettes per day). | Mean | Standard Deviation | Number of cigarettes smoked per day |
|
| OG001 | E-cigarette Switching (EC) + Financial Incentives | 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. |
|
|
| Primary | Combustible Cigarette Cessation | Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking) | Participants with missing cigarette smoking status were considered smoking. | Posted | Count of Participants | Participants | 8 weeks post-quit/switch date |
|
|
|
| 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) | Participants with missing smoking status were excluded from the analyses (i.e., complete case analysis). | Posted | Count of Participants | Participants | 4 weeks post-switch |
|
|
|
| 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) | Participants with missing smoking status data were excluded from the analyses (i.e., complete case analysis). | Posted | Count of Participants | Participants | 8 weeks post-switch |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ppm | 4 weeks post-switch |
|
|
|
| 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 | Posted | Mean | Standard Deviation | ppm | 8 week post-switch |
|
|
|
| Secondary | Days of Combustible Cigarette Smoking, Past 7 Days | The total number of days of combustible cigarette smoking during the past week | Posted | Mean | Standard Deviation | Days | 4 weeks post-switch |
|
|
|
| Secondary | Days of Combustible Cigarette Smoking, Past 7 Days | The total number of days of combustible cigarette smoking during the past 7 days | Posted | Mean | Standard Deviation | Days | 8 weeks post-switch |
|
|
|
| Secondary | Days of E-cigarette Use, Past 7 Days | The total number of days where e-cigarettes were used during the past 7 days | Posted | Mean | Standard Deviation | Days | 4 weeks post-switch |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Days | 8 weeks post-switch |
|
|
|
| Secondary | Follow-Up Completion | The number of participants who completed the smoking status follow-up assessment. | Posted | Count of Participants | Participants | 4 weeks post-switch |
|
|
|
| Secondary | Follow-Up Completion | The number of participants who completed the smoking status follow-up assessment | Posted | Count of Participants | Participants | 8 weeks post-switch |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | E-cigarette Switching (EC) + Financial Incentives | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
Not provided
| Health Behavior |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|