Cigarette SmokingEXCHANGENCT03743532
E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services
A study testing E-cigarette Switching and Financial Incentives in people with Cigarette Smoking, run by University of Oklahoma at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- E-cigarette Switching and Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- ≥21 years of age
- Expired CO level ≥8 ppm suggestive of current smoking
- reported smoking ≥5 cigarettes per day
- Willing and able to attend 8 study visits over a 10-week period
- Interested in switching from CCs to ECs
- Willing to abstain from smoking cannabis for the duration of the study
- Able to speak and understand English
- Demonstrated >6th grade English literacy by earning a score ≥4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF),
- Able to read a 3-sentence selection from the consent form
- Not pregnant, breastfeeding, or planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Needs Survey of Urban Day Shelter Users and Preliminary Evaluation of Alternative Approaches to Combustible Cigarette Cessation: The Exchange Project
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)
Read the 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.
- Conditions
- Cigarette Smoking
- Being tested
- E-cigarette Switching, Financial Incentives
- Keywords
- Smoking cessation, Contingency management, Financial incentives, E-cigarettes, Homelessness
- Medical subject headings
- Cigarette Smoking, Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarette SwitchingBehavioural
Also called EC
Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.
Financial IncentivesBehavioural
Also called FI
Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: E-cigarette Switching |
| 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. Receives: Behavioral: E-cigarette Switching; Behavioral: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combustible Cigarette Cessation
Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
Measured: 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)
Measured: 8 weeks post-quit/switch date
Secondary outcomes (10)
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)
Measured: 4 weeks post-switch
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 weeks post-switch
Follow-Up Completion
The number of participants who completed the smoking status follow-up assessment.
Measured: 4 weeks post-switch
Follow-Up Completion
The number of participants who completed the smoking status follow-up assessment
Measured: 8 weeks post-switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start14 Sep 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darla E. Kendzor, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743532
- Sponsor's protocol ID
- 10124
- Acronym
- EXCHANGE
- Status last verified
- Feb 2025
- First submitted
- 13 Nov 2018
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36844157Sifat 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.
PubMed 39764385
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Needs Survey of Urban Day Shelter Users and Preliminary Evaluation of Alternative Approaches to Combustible Cigarette Cessation: The Exchange Project
- ClinicalTrials.gov ID
- NCT03743532
- Acronym / sponsor ID
- EXCHANGE / 10124
- Conditions
- Cigarette Smoking
- Keywords
- Smoking cessation, Contingency management, Financial incentives, E-cigarettes, Homelessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-Cigarette Switching (EC) | Experimental | Behavioral: E-cigarette SwitchingParticipants 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 | Behavioral: E-cigarette Switching, Behavioral: Financial IncentivesParticipants 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigarette SwitchingAlso: ECParticipants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes. | Behavioural | E-Cigarette Switching (EC), E-Cigarette Switching + Financial Incentives (EC+FI) |
| Financial IncentivesAlso: FIParticipants earned incentives for carbon monoxide-verified combustible cigarette abstinence. | Behavioural | E-Cigarette Switching + Financial Incentives (EC+FI) |
Primary outcome
Combustible Cigarette Cessation
Time frame: 4 weeks post-switch date
Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
Combustible Cigarette Cessation
Time frame: 8 weeks post-quit/switch date
Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
10 secondary outcomes
Combustible Cigarette Cessation (Complete Case Analysis)
Time frame: 4 weeks post-switch
Combustible Cigarette Cessation (Complete Case Analysis)
Time frame: 8 weeks post-switch
Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline
Time frame: 4 weeks post-switch
Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline
Time frame: 8 week post-switch
Days of Combustible Cigarette Smoking, Past 7 Days
Time frame: 4 weeks post-switch
Days of Combustible Cigarette Smoking, Past 7 Days
Time frame: 8 weeks post-switch
Days of E-cigarette Use, Past 7 Days
Time frame: 4 weeks post-switch
Days of E-cigarette Use, Past 7 Days
Time frame: 8 weeks post-switch
Follow-Up Completion
Time frame: 4 weeks post-switch
Follow-Up Completion
Time frame: 8 weeks post-switch
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36844157Boozary 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.
- Results publication: PubMed 39764385Sifat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darla E. Kendzor, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette Switching and Financial Incentives in people with Cigarette Smoking, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combustible Cigarette Cessation (time frame: 4 weeks post-switch date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03743532, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.