- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743532
E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services (EXCHANGE)
February 7, 2025 updated by: University of Oklahoma
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73106
- Homeless Alliance
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
- ≥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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: E-Cigarette Switching (EC)
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.
|
Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.
Other Names:
|
|
Experimental: E-Cigarette Switching + Financial Incentives (EC+FI)
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.
|
Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.
Other Names:
Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
4 weeks post-switch date
|
|
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)
|
8 weeks post-quit/switch date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Combustible Cigarette Cessation (Complete Case Analysis)
Time Frame: 4 weeks post-switch
|
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)
Time Frame: 8 weeks post-switch
|
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
Time Frame: 4 weeks post-switch
|
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
Time Frame: 8 week post-switch
|
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
Time Frame: 4 weeks post-switch
|
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
Time Frame: 8 weeks post-switch
|
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
Time Frame: 4 weeks post-switch
|
The total number of days where e-cigarettes were used during the past 7 days
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4 weeks post-switch
|
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Days of E-cigarette Use, Past 7 Days
Time Frame: 8 weeks post-switch
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The total number of days on which E-cigarettes were used during the past 7 days
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8 weeks post-switch
|
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Follow-Up Completion
Time Frame: 4 weeks post-switch
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The number of participants who completed the smoking status follow-up assessment.
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4 weeks post-switch
|
|
Follow-Up Completion
Time Frame: 8 weeks post-switch
|
The number of participants who completed the smoking status follow-up assessment
|
8 weeks post-switch
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Darla E. Kendzor, PhD, University of Oklahoma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2022
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
November 13, 2018
First Submitted That Met QC Criteria
November 13, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 7, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 10124
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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