Cigarette Smoking BehaviorESHIFTNCT07897058
Project E-Shift: A Harm Reduction Intervention for Chronically Unhoused Smokers.
A study testing E-cigarette, Nicotine replacement therapy (patch, gum), both arms and CO-contingent financial incentives, both arms in people with Cigarette Smoking Behavior and E-Cigarette Use, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This pilot randomized trial tested whether switching to e-cigarettes, compared with standard nicotine replacement therapy (NRT; patch and gum), helped adults with a history of chronic homelessness stop smoking combustible cigarettes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cigarette Smoking Behavior, E-Cigarette Use
- What is being tested?
- E-cigarette, Nicotine replacement therapy (patch, gum), both arms and CO-contingent financial incentives, both arms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study.
- Male or female aged 21 and above.
- expired CO >6 ppm at screening
- People of reproductive potential must not be pregnant nor trying to become pregnant.
- Adequate literacy to complete self-administered study questionnaires, defined as a score ≥4 out of 7 on the Rapid Estimate of Adult Literacy in Medicine - Short Form (REALM-SF), corresponding to a 7th-grade reading level or higher
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded.
- Medical condition that precludes participation
- Current use of THC-containing vaping products
- Pregnancy or lactation
- Known allergic reactions to components of the study product(s)
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pathways to Housing
Philadelphia, Pennsylvania, 19107
About this study
Official title: Project E-Shift: A Harm Reduction Intervention for Chronically Unhoused Smokers
This pilot randomized trial tested whether switching to e-cigarettes, compared with standard nicotine replacement therapy (NRT; patch and gum), helped adults with a history of chronic homelessness stop smoking combustible cigarettes. All participants received brief cessation counseling and incentives for carbon monoxide (CO)-verified abstinence from cigarettes during the first weeks after a scheduled switch date. Participants were followed for 12 weeks after switching, with a final follow-up at 24 weeks. The study also assessed feasibility (recruitment, retention, and visit attendance) and used interviews with participants and service-agency staff to understand acceptability and how a tobacco harm reduction program could fit into existing housing and clinic services.
Read the detailed description
This two-arm, parallel-group, open-label pilot randomized trial compared e-cigarette (EC) switching with nicotine replacement therapy (NRT) among adults who smoke cigarettes and have a history of chronic homelessness, recruited through Pathways to Housing PA and affiliated clinic services in Philadelphia [confirm sites]. Both arms received standard cessation counseling and financial incentives contingent on carbon monoxide (CO)-verified abstinence from combustible cigarettes during the early post-switch period. Because both arms received incentives, the trial compares EC with NRT in the presence of incentives and does not isolate the effect of incentives.
After consent and baseline assessment, participants were randomized 1:1 to EC plus financial incentives (EC+FI) or NRT plus financial incentives (NRT+FI). EC+FI participants received a pod-based device and a one-week practice supply of pods before a scheduled switch date one week after baseline. NRT+FI participants received nicotine patch and gum. At consent, all participants were counseled on e-cigarette or vaping use-associated lung injury (EVALI) and instructed not to use THC-containing, non-study, or modified vaping products.
Assessments occurred on the switch date, weekly at 1 through 4 weeks post-switch, and at 8, 10, and 12 weeks post-switch, with a final self-report follow-up at 24 weeks post-switch. Visits included self-report questionnaires on tobacco and nicotine product use, withdrawal symptoms, respiratory symptoms, and mental health, and expired CO measurement (through week 12). Abstinence-contingent incentives were available from the switch date through week 4 only; later visits were unincentivized to assess maintenance after incentive withdrawal. Study product was resupplied at each visit through week 8, with EC pods dosed to pre-switch cigarettes per day and used pods returned before resupply, and was then discontinued to assess unsupported continuation.
A subsample of participants and partner-agency staff completed semi-structured interviews on intervention acceptability and on integrating tobacco harm reduction into existing service workflows.
- Conditions
- Cigarette Smoking Behavior, E-Cigarette Use
- Being tested
- E-cigarette, Nicotine replacement therapy (patch, gum), both arms, CO-contingent financial incentives, both arms, Cessation counseling
- Keywords
- cigarette, e-cigarette
- Medical subject headings
- Cigarette Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigaretteOther
Pod-based e-cigarette device [Vuse Alto, 5 % nicotine] given at baseline, with 3 pods for a 1-week practice period. Starting on switch day, participants receive weekly pod supplies in flavors of their choice, dosed to pre-switch cigarettes per day, through 8 weeks post-switch. Used pods are returned before resupply. One replacement device is provided if the device is lost or damaged.
Nicotine replacement therapy (patch, gum), both armsDrug
Also called E-cigarette, EC arm
Participants receive Nicotine Replacement Therapy (patch, gum)
CO-contingent financial incentives, both armsBehavioural
CO-contingent financial incentives, both arms
Cessation counselingBehavioural
Cessation counseling, all arms
| Study group | Role | What they receive |
|---|---|---|
| NRT as Cigarette Product Replacement | Active comparator | Either participants receive NRT as cigarette product replacement Receives: Drug: Nicotine replacement therapy (patch, gum), both arms; Behavioral: CO-contingent financial incentives, both arms; Behavioral: Cessation counseling |
| E-Cigarette as cigarette product replacement | Experimental | Participants receive E-Cigarette as cigarette product replacement Receives: Other: E-cigarette; Drug: Nicotine replacement therapy (patch, gum), both arms; Behavioral: CO-contingent financial incentives, both arms; Behavioral: Cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Carbon Monoxide (CO)-Verified Combustible Cigarette Abstinence
Abstinence is defined as self-report of no combustible cigarette smoking in the past 7 days AND expired CO ≤6 parts per million (Vitalograph CO monitor). Reported by arm at each time point. Participants with missing data at a time point are counted as not abstinent (intention-to-treat).
Measured: 4, 8, and 12 weeks post-switch
Secondary outcomes (6)
Expired Carbon Monoxide (CO) Level
Mean expired CO in parts per million, measured by Vitalograph CO monitor. Lower values indicate less recent combustible smoke exposure.
Measured: Switch date (1 week post-baseline) and 1, 2, 3, 4, 8, 10, and 12 weeks post-switch
Number of Days Smoking Combustible Cigarettes in the Past 7 Days
Self-reported number of days (range 0-7) on which the participant smoked combustible cigarettes in the past 7 days. Higher values indicate more smoking.
Measured: 1, 2, 3, 4, 8, 10, 12, and 24 weeks post-switch
Number of Participants by Past-7-Day Product Use Category
Mutually exclusive categories derived from self-report: e-cigarette use only, combustible cigarette use only, dual use, and no use of either product.
Measured: 1, 2, 3, 4, 8, 10, 12, and 24 weeks post-switch
Number of Participants With Self-Reported 7-Day Point-Prevalence Combustible Cigarette Abstinence
Self-report of no combustible cigarette smoking in the past 7 days. CO verification was not performed at this visit.
Measured: 24 weeks post-switch
Number of Participants Maintaining CO-Verified Abstinence After Incentive Discontinuation
Among participants with CO-verified combustible cigarette abstinence (self-report of no smoking in the past 7 days and expired CO ≤6 ppm) at week 4, the final incentivized visit, the number who remain CO-verified abstinent at unincentivized follow-up visits.
Measured: 8, 10, and 12 weeks post-switch
Number of Randomized Participants Retained at 12 Weeks
Number of randomized participants who completed the 12-week post-switch assessment.
Measured: 12 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 posted27 Oct 2026
- Study start5 Aug 2025
- Primary completion12 May 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking BehaviorStudies of the same condition, open and under way.
- 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
- Model description
- Half the participants will be given an e-cigarette device with charger and pods, they will also receive counseling, and NRT will be available to them upon request. The standard care group will receive nicotine replacement therapy which includes counseling and nicotine replacement products. Further, all participants will be able to earn financial incentives if they are abstinent from combustible cigarette smoking to encourage reduction of combustible cigarette use.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Munjireen Sifat, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897058
- Sponsor's protocol ID
- 45309
- Acronym
- ESHIFT
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Populations with experiences of homelessness are uniquely vulnerable.
Publications
Leavens ELS, Pebley K, Smith TT, Ahluwalia JS, Bello MS, Bold KW, Cantrell J, Carpenter MJ, Cioe PA, Felicione NJ, Havard A, Hawk LW Jr, Kaye JT, Klemperer EM, Kleykamp BA, Lindson N, McClure EA, McRobbie H, Murphy CM, Rigotti NA, Walker NK, Yang MJ, Rojewski AM, Johnson AL; Members of the Society for Research on Nicotine and Tobacco, Treatment Research Network, Harm Reduction Workgroup. Nicotine E-Cigarettes for Cigarette Smoking Cessation: Recommendations to US-Based Clinicians. JAMA. 2026 Sep 1;336(9):783-790. doi: 10.1001/jama.2026.13087.
PubMed 42530900Sifat 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 39764385Businelle MS, Ma P, Kendzor DE, Reitzel LR, Chen M, Lam CY, Bernstein I, Wetter DW. Predicting quit attempts among homeless smokers seeking cessation treatment: an ecological momentary assessment study. Nicotine Tob Res. 2014 Oct;16(10):1371-8. doi: 10.1093/ntr/ntu088. Epub 2014 Jun 3.
PubMed 24893602Wagener TL, Meier E, Hale JJ, Oliver ER, Warner ML, Driskill LM, Gillaspy SR, Siegel MB, Foster S. Pilot investigation of changes in readiness and confidence to quit smoking after E-cigarette experimentation and 1 week of use. Nicotine Tob Res. 2014 Jan;16(1):108-14. doi: 10.1093/ntr/ntt138. Epub 2013 Oct 23.
PubMed 24154511Reitzel LR, Kendzor DE, Nguyen N, Regan SD, Okuyemi KS, Castro Y, Wetter DW, Businelle MS. Shelter proximity and affect among homeless smokers making a quit attempt. Am J Health Behav. 2014 Mar;38(2):161-9. doi: 10.5993/AJHB.38.2.1.
PubMed 24629545Nguyen MA, Reitzel LR, Kendzor DE, Businelle MS. Perceived cessation treatment effectiveness, medication preferences, and barriers to quitting among light and moderate/heavy homeless smokers. Drug Alcohol Depend. 2015 Aug 1;153:341-5. doi: 10.1016/j.drugalcdep.2015.05.039. Epub 2015 Jun 6.
PubMed 26072221Kish DH, Reitzel LR, Kendzor DE, Okamoto H, Businelle MS. Characterizing Concurrent Tobacco Product Use Among Homeless Cigarette Smokers. Nicotine Tob Res. 2015 Sep;17(9):1156-60. doi: 10.1093/ntr/ntu230. Epub 2014 Oct 30.
PubMed 25358660Kendzor DE, Reitzel LR, Businelle MS. Characterizing Stressors and Modifiable Health Risk Factors Among Homeless Smokers: An Exploratory Pilot Study. Health Educ Behav. 2015 Oct;42(5):642-7. doi: 10.1177/1090198114565664. Epub 2015 Jan 23.
PubMed 25616410Kendzor DE, Allicock M, Businelle MS, Sandon LF, Gabriel KP, Frank SG. Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults. J Phys Act Health. 2017 Feb;14(2):88-97. doi: 10.1123/jpah.2016-0343. Epub 2016 Oct 24.
PubMed 27775471Hajek P, Etter JF, Benowitz N, Eissenberg T, McRobbie H. Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit. Addiction. 2014 Nov;109(11):1801-10. doi: 10.1111/add.12659. Epub 2014 Jul 31.
PubMed 25078252Wagener TL, Floyd EL, Stepanov I, Driskill LM, Frank SG, Meier E, Leavens EL, Tackett AP, Molina N, Queimado L. Have combustible cigarettes met their match? The nicotine delivery profiles and harmful constituent exposures of second-generation and third-generation electronic cigarette users. Tob Control. 2017 Mar;26(e1):e23-e28. doi: 10.1136/tobaccocontrol-2016-053041. Epub 2016 Oct 11.
PubMed 27729564Kotz D, West R. Explaining the social gradient in smoking cessation: it's not in the trying, but in the succeeding. Tob Control. 2009 Feb;18(1):43-6. doi: 10.1136/tc.2008.025981. Epub 2008 Oct 20.
PubMed 18936053Kendzor DE, Reitzel LR, Mazas CA, Cofta-Woerpel LM, Cao Y, Ji L, Costello TJ, Vidrine JI, Businelle MS, Li Y, Castro Y, Ahluwalia JS, Cinciripini PM, Wetter DW. Individual- and area-level unemployment influence smoking cessation among African Americans participating in a randomized clinical trial. Soc Sci Med. 2012 May;74(9):1394-401. doi: 10.1016/j.socscimed.2012.01.013. Epub 2012 Feb 23.
PubMed 22405506Kendzor DE, Businelle MS, Costello TJ, Castro Y, Reitzel LR, Cofta-Woerpel LM, Li Y, Mazas CA, Vidrine JI, Cinciripini PM, Greisinger AJ, Wetter DW. Financial strain and smoking cessation among racially/ethnically diverse smokers. Am J Public Health. 2010 Apr;100(4):702-6. doi: 10.2105/AJPH.2009.172676. Epub 2010 Feb 18.
PubMed 20167886Baggett TP, Rigotti NA. Cigarette smoking and advice to quit in a national sample of homeless adults. Am J Prev Med. 2010 Aug;39(2):164-72. doi: 10.1016/j.amepre.2010.03.024.
PubMed 20621264
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project E-Shift: A Harm Reduction Intervention for Chronically Unhoused Smokers
- ClinicalTrials.gov ID
- NCT07897058
- Acronym / sponsor ID
- ESHIFT / 45309
- Conditions
- Cigarette Smoking Behavior, E-Cigarette Use
- Keywords
- cigarette, e-cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomized trial tested whether switching to e-cigarettes, compared with standard nicotine replacement therapy (NRT; patch and gum), helped adults with a history of chronic homelessness stop smoking combustible cigarettes. All participants received brief cessation counseling and incentives for carbon monoxide (CO)-verified abstinence from cigarettes during the first weeks after a scheduled switch date. Participants were followed for 12 weeks after switching, with a final follow-up at 24 weeks. The study also assessed feasibility (recruitment, retention, and visit attendance) and used interviews with participants and service-agency staff to understand acceptability and how a tobacco harm reduction program could fit into existing housing and clinic services.
Detailed description
This two-arm, parallel-group, open-label pilot randomized trial compared e-cigarette (EC) switching with nicotine replacement therapy (NRT) among adults who smoke cigarettes and have a history of chronic homelessness, recruited through Pathways to Housing PA and affiliated clinic services in Philadelphia [confirm sites]. Both arms received standard cessation counseling and financial incentives contingent on carbon monoxide (CO)-verified abstinence from combustible cigarettes during the early post-switch period. Because both arms received incentives, the trial compares EC with NRT in the presence of incentives and does not isolate the effect of incentives.
After consent and baseline assessment, participants were randomized 1:1 to EC plus financial incentives (EC+FI) or NRT plus financial incentives (NRT+FI). EC+FI participants received a pod-based device and a one-week practice supply of pods before a scheduled switch date one week after baseline. NRT+FI participants received nicotine patch and gum. At consent, all participants were counseled on e-cigarette or vaping use-associated lung injury (EVALI) and instructed not to use THC-containing, non-study, or modified vaping products.
Assessments occurred on the switch date, weekly at 1 through 4 weeks post-switch, and at 8, 10, and 12 weeks post-switch, with a final self-report follow-up at 24 weeks post-switch. Visits included self-report questionnaires on tobacco and nicotine product use, withdrawal symptoms, respiratory symptoms, and mental health, and expired CO measurement (through week 12). Abstinence-contingent incentives were available from the switch date through week 4 only; later visits were unincentivized to assess maintenance after incentive withdrawal. Study product was resupplied at each visit through week 8, with EC pods dosed to pre-switch cigarettes per day and used pods returned before resupply, and was then discontinued to assess unsupported continuation.
A subsample of participants and partner-agency staff completed semi-structured interviews on intervention acceptability and on integrating tobacco harm reduction into existing service workflows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Half the participants will be given an e-cigarette device with charger and pods, they will also receive counseling, and NRT will be available to them upon request. The standard care group will receive nicotine replacement therapy which includes counseling and nicotine replacement products. Further, all participants will be able to earn financial incentives if they are abstinent from combustible cigarette smoking to encourage reduction of combustible cigarette use.
| Arm | Type | Receives |
|---|---|---|
| NRT as Cigarette Product Replacement | Active comparator | Drug: Nicotine replacement therapy (patch, gum), both arms, Behavioral: CO-contingent financial incentives, both arms, Behavioral: Cessation counselingEither participants receive NRT as cigarette product replacement |
| E-Cigarette as cigarette product replacement | Experimental | Other: E-cigarette, Drug: Nicotine replacement therapy (patch, gum), both arms, Behavioral: CO-contingent financial incentives, both arms, Behavioral: Cessation counselingParticipants receive E-Cigarette as cigarette product replacement |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Adequate literacy to complete self-administered study questionnaires, defined as a score ≥4 out of 7 on the Rapid Estimate of Adult Literacy in Medicine - Short Form (REALM-SF), corresponding to a 7th-grade reading level or higher
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
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-cigarettePod-based e-cigarette device [Vuse Alto, 5 % nicotine] given at baseline, with 3 pods for a 1-week practice period. Starting on switch day, participants receive weekly pod supplies in flavors of their choice, dosed to pre-switch cigarettes per day, through 8 weeks post-switch. Used pods are returned before resupply. One replacement device is provided if the device is lost or damaged. | Other | E-Cigarette as cigarette product replacement |
| Nicotine replacement therapy (patch, gum), both armsAlso: E-cigarette, EC armParticipants receive Nicotine Replacement Therapy (patch, gum) | Drug | E-Cigarette as cigarette product replacement, NRT as Cigarette Product Replacement |
| CO-contingent financial incentives, both armsCO-contingent financial incentives, both arms | Behavioural | E-Cigarette as cigarette product replacement, NRT as Cigarette Product Replacement |
| Cessation counselingCessation counseling, all arms | Behavioural | E-Cigarette as cigarette product replacement, NRT as Cigarette Product Replacement |
Primary outcome
Number of Participants With Carbon Monoxide (CO)-Verified Combustible Cigarette Abstinence
Time frame: 4, 8, and 12 weeks post-switch
Abstinence is defined as self-report of no combustible cigarette smoking in the past 7 days AND expired CO ≤6 parts per million (Vitalograph CO monitor). Reported by arm at each time point. Participants with missing data at a time point are counted as not abstinent (intention-to-treat).
6 secondary outcomes
Expired Carbon Monoxide (CO) Level
Time frame: Switch date (1 week post-baseline) and 1, 2, 3, 4, 8, 10, and 12 weeks post-switch
Number of Days Smoking Combustible Cigarettes in the Past 7 Days
Time frame: 1, 2, 3, 4, 8, 10, 12, and 24 weeks post-switch
Number of Participants by Past-7-Day Product Use Category
Time frame: 1, 2, 3, 4, 8, 10, 12, and 24 weeks post-switch
Number of Participants With Self-Reported 7-Day Point-Prevalence Combustible Cigarette Abstinence
Time frame: 24 weeks post-switch
Number of Participants Maintaining CO-Verified Abstinence After Incentive Discontinuation
Time frame: 8, 10, and 12 weeks post-switch
Number of Randomized Participants Retained at 12 Weeks
Time frame: 12 weeks post-switch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 42530900Leavens ELS, Pebley K, Smith TT, Ahluwalia JS, Bello MS, Bold KW, Cantrell J, Carpenter MJ, Cioe PA, Felicione NJ, Havard A, Hawk LW Jr, Kaye JT, Klemperer EM, Kleykamp BA, Lindson N, McClure EA, McRobbie H, Murphy CM, Rigotti NA, Walker NK, Yang MJ, Rojewski AM, Johnson AL; Members of the Society for Research on Nicotine and Tobacco, Treatment Research Network, Harm Reduction Workgroup. Nicotine E-Cigarettes for Cigarette Smoking Cessation: Recommendations to US-Based Clinicians. JAMA. 2026 Sep 1;336(9):783-790. doi: 10.1001/jama.2026.13087.
- Background: 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.
- Background: PubMed 24893602Businelle MS, Ma P, Kendzor DE, Reitzel LR, Chen M, Lam CY, Bernstein I, Wetter DW. Predicting quit attempts among homeless smokers seeking cessation treatment: an ecological momentary assessment study. Nicotine Tob Res. 2014 Oct;16(10):1371-8. doi: 10.1093/ntr/ntu088. Epub 2014 Jun 3.
- Background: PubMed 24154511Wagener TL, Meier E, Hale JJ, Oliver ER, Warner ML, Driskill LM, Gillaspy SR, Siegel MB, Foster S. Pilot investigation of changes in readiness and confidence to quit smoking after E-cigarette experimentation and 1 week of use. Nicotine Tob Res. 2014 Jan;16(1):108-14. doi: 10.1093/ntr/ntt138. Epub 2013 Oct 23.
- Background: PubMed 24629545Reitzel LR, Kendzor DE, Nguyen N, Regan SD, Okuyemi KS, Castro Y, Wetter DW, Businelle MS. Shelter proximity and affect among homeless smokers making a quit attempt. Am J Health Behav. 2014 Mar;38(2):161-9. doi: 10.5993/AJHB.38.2.1.
- Background: PubMed 26072221Nguyen MA, Reitzel LR, Kendzor DE, Businelle MS. Perceived cessation treatment effectiveness, medication preferences, and barriers to quitting among light and moderate/heavy homeless smokers. Drug Alcohol Depend. 2015 Aug 1;153:341-5. doi: 10.1016/j.drugalcdep.2015.05.039. Epub 2015 Jun 6.
- Background: PubMed 25358660Kish DH, Reitzel LR, Kendzor DE, Okamoto H, Businelle MS. Characterizing Concurrent Tobacco Product Use Among Homeless Cigarette Smokers. Nicotine Tob Res. 2015 Sep;17(9):1156-60. doi: 10.1093/ntr/ntu230. Epub 2014 Oct 30.
- Background: PubMed 25616410Kendzor DE, Reitzel LR, Businelle MS. Characterizing Stressors and Modifiable Health Risk Factors Among Homeless Smokers: An Exploratory Pilot Study. Health Educ Behav. 2015 Oct;42(5):642-7. doi: 10.1177/1090198114565664. Epub 2015 Jan 23.
- Background: PubMed 27775471Kendzor DE, Allicock M, Businelle MS, Sandon LF, Gabriel KP, Frank SG. Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults. J Phys Act Health. 2017 Feb;14(2):88-97. doi: 10.1123/jpah.2016-0343. Epub 2016 Oct 24.
- Background: PubMed 25078252Hajek P, Etter JF, Benowitz N, Eissenberg T, McRobbie H. Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit. Addiction. 2014 Nov;109(11):1801-10. doi: 10.1111/add.12659. Epub 2014 Jul 31.
- Background: PubMed 27729564Wagener TL, Floyd EL, Stepanov I, Driskill LM, Frank SG, Meier E, Leavens EL, Tackett AP, Molina N, Queimado L. Have combustible cigarettes met their match? The nicotine delivery profiles and harmful constituent exposures of second-generation and third-generation electronic cigarette users. Tob Control. 2017 Mar;26(e1):e23-e28. doi: 10.1136/tobaccocontrol-2016-053041. Epub 2016 Oct 11.
- Background: PubMed 18936053Kotz D, West R. Explaining the social gradient in smoking cessation: it's not in the trying, but in the succeeding. Tob Control. 2009 Feb;18(1):43-6. doi: 10.1136/tc.2008.025981. Epub 2008 Oct 20.
- Fiore MC, Jaen CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ. Treating Tobacco Use and Dependence: 2008 Update. USDHHS. Clinical Practice Guideline Web site.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Populations with experiences of homelessness are uniquely vulnerable.
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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.
Munjireen Sifat principal investigator
Thomas Jefferson University
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, Nicotine replacement therapy (patch, gum), both arms and CO-contingent financial incentives, both arms in people with Cigarette Smoking Behavior and E-Cigarette Use, run by Thomas Jefferson University 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?
The sponsor lists 7 inclusion and 7 exclusion criteria. 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 27 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With Carbon Monoxide (CO)-Verified Combustible Cigarette Abstinence (time frame: 4, 8, and 12 weeks post-switch). 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 NCT07897058, which also lists 17 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 27 Oct 2026.