An interventional study of E-cigarette and Nicotine replacement therapy (patch, gum), both arms in Cigarette Smoking Behavior and E-Cigarette Use, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment
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.
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.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's enrollment of 44 is below the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Either participants receive NRT as cigarette product replacement
Drug: Nicotine replacement therapy (patch, gum), both arms · Behavioral: CO-contingent financial incentives, both arms · Behavioral: Cessation counseling
Participants receive E-Cigarette as cigarette product replacement
Other: E-cigarette · Drug: Nicotine replacement therapy (patch, gum), both arms · Behavioral: CO-contingent financial incentives, both arms · Behavioral: Cessation counseling
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.
Participants receive Nicotine Replacement Therapy (patch, gum)
Also known as: E-cigarette, EC arm
CO-contingent financial incentives, both arms
Cessation counseling, all arms
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).
Time frame: 4, 8, and 12 weeks post-switch
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.
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
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.
Time frame: 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.
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
Self-report of no combustible cigarette smoking in the past 7 days. CO verification was not performed at this visit.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks post-switch
Withdrawal and Craving Symptoms as Measured by the Wisconsin Smoking Withdrawal Scale 2, Brief Version (WSWS2-B)
The WSWS2-B is a 6-item self-report measure of nicotine withdrawal and craving symptoms in the past 24 hours (feeling upset, thinking about food, wanting to smoke, troubled sleep, feeling restless, trouble concentrating). Items are rated from 1 (not at all) to 7 (extremely), and the overall score is the mean of the 6 items. Range 1-7; higher scores indicate greater withdrawal and craving (worse outcome). At some visits, items 4-6 were administered on a 0-100 or 0-7 slider and were linearly rescaled to the 1-7 metric before scoring.
Time frame: Baseline; switch date (1 week post-baseline); and 1, 2, 3, 4, 8, 10, and 12 weeks post-switch
Respiratory Symptoms as Measured by the American Thoracic Society Questionnaire (ATSQ) Total Score
8 self-report items assessing current frequency of respiratory symptoms (morning cough, cough throughout the day, wheezing, shortness of breath when walking, shortness of breath during exercise or stair climbing, phlegm with cough, chest pain or tightness, and getting very tired in a short time). Each item is rated from 1 (never) to 5 (every day), and the total score is the sum of the 8 items. Range 8-40; higher scores indicate more frequent respiratory symptoms (worse outcome).
Time frame: Baseline; switch date (1 week post-baseline); and 1, 2, 3, 4, 8, 10, and 12 weeks post-switch
Plan to share: No — Populations with experiences of homelessness are uniquely vulnerable.
Ran from Aug 2025 to primary completion in May 2026, 9 months.
Of 184 non-industry interventional studies with no phase under Cigarette Smoking, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 33. This study's 9 months is below that.
Counting every sponsor, half of 191 studies reached it within 20 months; a quarter within 9 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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