An interventional study of E-cigarettes and Oral nicotine pouches in E-cigarette Use, Cigarette Smoking and Harm Reduction, sponsored by Abramson Cancer Center at Penn Medicine. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Basic science
This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms.
E-cigarettes (ECIGS), and oral nicotine pouches (ONPs), expose users to few of the chemicals found in cigarette smoke and are thus promising noncombustible harm reduction tools for smokers who would not otherwise quit smoking. For their harm reduction potential to be realized, fundamental questions must be answered. One, can persistent smokers switch from combustible cigarettes to either ECIGS or ONPS? Two, what factors influence switching? Three, does one of these noncombustible alternatives expose users to lower levels of harmful chemicals than the other? The proposed research will fill these gaps in the evidence base by randomizing 200 persistent cigarette smokers to a six-week regimen of ECIGS or ONPS. Baseline smoking rate will be established during days 1-5. After biochemically confirmed overnight smoking abstinence, laboratory visits on days 6 and 7 will assess ECIG and ONP-associated subjective reward and the reinforcing value of either ECIGS or ONPS relative to combustible cigarettes. Participants will switch from cigarette smoking to ECIGS or ONPS for the following six weeks. The primary outcome measure is the longitudinal daily count of cigarettes from baseline to the end of the six-week switch period, measured via a validated collection protocol with cigarettes per day (cpd) at a 6-month follow-up as a secondary endpoint. Changes in biomarkers of potential harm, assessed at baseline and the end of the six-week switch phase, will be secondary outcome measures.
402 studies on the registry are indexed under Vaping; 95 are open to participants now.
This study's planned enrollment of 200 is above the median of 79 across 322 interventional studies indexed under Vaping.
Browse Vaping studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 460 studies on the registry; 87 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) 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.
Exclusion Criteria:
Smoking Behavior
Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette and nicotine pouch use is defined as greater than 5 days/past 30 days.
a. Participants agreeing to abstain from using nicotine-containing products other than cigarettes for the duration of the study will be considered eligible.
Alcohol and Drug
Medical
Psychiatric
1. Lifetime history of schizophrenia or psychosis.
General Exclusion
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.
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.
Participants randomized to ECIGS will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study-provided e-cigarette device. Participants will be able to choose between Tobacco, Menthol, Watermelon, and Blueberry flavored nicotine pods. They will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior.
Other: E-cigarettes
Participants randomized to ONPS will be provided with oral nicotine pouches and be instructed to switch from smoking combustible cigarettes to using only the study-provided nicotine pouches. Participants will be able to choose between Original, Mint, Berry, and Citrus flavored nicotine pouches. They will receive their supply of nicotine pouches in 7-day increments, based on baseline smoking behavior.
Other: Oral nicotine pouches
Participants randomized to ECIGS are instructed to switch from smoking combustible cigarettes to using e-cigarettes for 6 weeks. They will be provided with an e-cigarette device and nicotine pods.
Participants randomized to ONPS are instructed to switch from smoking combustible cigarettes to using nicotine pouches for 6 weeks. They will be provided with nicotine pouches.
Cigarette Consumption
The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the switch phase. Daily cigarette consumption will be determined by counting the daily spent cigarette filters returned for each of the 42 days (days 8 - 49).
Time frame: 42 days (days 8 - 49)
Cigarette Smoking Across Follow-Up
Average cigarettes per day at the 6-month follow-up is a secondary endpoint, measured by the valid and reliable timeline follow-back (TLFB) interview.
Time frame: 19 Weeks (Day 50-6-Month Follow-Up)
Biomarkers of Exposure: Carbon Monoxide (CO)
Carbon Monoxide (CO) will be measured using a CO monitor. A CO \> 5 ppm indicates combustible cigarette smoking.
Time frame: 49 days (days 1-49)
Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%)
The mean mid-expiratory forced expiratory flow (FEF25% - 75%) is a measure of lung function and inflammation. FEF25% - 75% will be assessed using spirometry according to the American Thoracic Guidelines.
Time frame: 49 days (days 1-49)
Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) is a primary nitrosamine marker of tobacco exposure and an often-used indicator of carcinogen exposure. NNAL will be measured in urine and assessed through Liquid Chromatography-Tandem Mass Spectrometry per milligram creatinine (LC-MS/MS per mg creatinine).
Time frame: 49 days (days 1-49)
Biomarkers of Exposure:1-hydroxypyrene (1-HOP)
1-hydroxypyrene (1-HOP) is a widely used biomarker of carcinogenic polycyclic aromatic hydrocarbon exposure. 1-HOP will be measured in urine and assessed through Liquid Chromatography-Tandem Mass Spectrometry per milligram creatinine (LC-MS/MS per mg creatinine).
Time frame: 49 days (days 1-49)
Started Oct 2024 (actual). Primary completion is estimated for Nov 2027, 37 months after the start.
Of 184 non-industry interventional studies with no phase under Vaping, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 37 months is above that.
Counting every sponsor, half of 208 studies reached it within 18 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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