An interventional study of Vaping - Fruit flavored ENDS and Biospecimen Collection in Tobacco Cessation and Electronic Nicotine Delivery Systems, sponsored by Roswell Park Cancer Institute. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Prevention
This clinical trial studies whether different flavored electronic nicotine delivery systems (ENDS) help lower smoking and exposure to tobacco toxicants among cigarette smokers interested in reducing their smoking. ENDS are battery-powered electronic devices designed to deliver a nicotine-containing liquid solution for inhalation. They do not burn tobacco. Previous research has shown that ENDS have the potential to lower exposure to potentially toxic substances compared to burned cigarettes as well as lower short-term adverse health outcomes. However, there are many different ENDS products with varying characteristics, including different flavors, and a need remains to understand more how flavors affect ENDS use, the potential reduction in cigarette use, and exposure to toxicants. This trial studies how two different flavors, fruit and tobacco, affect an individual's smoking behavior and ultimately whether flavored ENDS can help lower smoking and exposure to tobacco toxicants among cigarette smokers interested in reducing their smoking.
PRIMARY OBJECTIVES:
I. To assess the impact of ENDS flavors (fruit versus [vs.] tobacco) on combustible cigarette smoking intensity by comparing the mean change in cigarettes per day (CPD) from baseline to 12 months in individuals who initiate ENDS use.
276 studies on the registry are indexed under Tobacco Use Cessation; 45 are open to participants now.
This study's planned enrollment of 286 is above the median of 226 across 256 interventional studies indexed under Tobacco Use Cessation.
Browse Tobacco Use Cessation studies →Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive and use fruit flavored ENDS ad libitum for 12 months in the absence of unacceptable toxicity. Participants also undergo urine sample collection on study.
Other: Vaping - Fruit flavored ENDS · Procedure: Biospecimen Collection
Participants receive and use tobacco flavored ENDS ad libitum for 12 months in the absence of unacceptable toxicity. Participants also undergo urine sample collection on study.
Procedure: Biospecimen Collection · Other: Vaping - tobacco flavored ENDS
Receive and use fruit flavored ENDS
Undergo urine sample collection
receive and use tobacco flavored ENDS
Change in Cigarettes per day (CPD) from baseline to 12 month follow up visit
CPD reduction at month 12 compared to baseline
Time frame: baseline to 12 months
Measure Change in biomarker concentration NNAL
urinary measure of NNAL
Time frame: From Baseline to 12 months
Proportion of participants achieving a greater than or equal to 50% reduction in Cigarettes Per Day
Will be summarized by treatment group and compared between participants who received fruit-flavored ENDS and those who received tobacco-flavored ENDS.
Time frame: Baseline to 12 months
Proportion of participants achieving a 100% reduction in CPD
Self reported - Will be summarized by treatment group and compared between participants who received fruit-flavored ENDS and those who received tobacco-flavored ENDS.
Time frame: Baseline to 12 months
Proportion of participants achieving a greater than or equal to 50% reduction in urinary NNAL
Will be summarized by treatment group and compared between participants who received fruit-flavored ENDS and those who received tobacco-flavored ENDS
Time frame: Baseline to 12 months
Proportion of participants achieving a 100% reduction in NNAL
Will be summarized by treatment group and compared between participants who received fruit-flavored ENDS and those who received tobacco-flavored ENDS
Time frame: Baseline to 12 months
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 115 non-industry interventional studies with no phase under Tobacco Use Cessation, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 116 studies reached it within 24 months; a quarter within 15 and three quarters within 40.
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 not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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