Tobacco CessationREFLECTNCT07896330
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
A study testing Vaping - Fruit flavored ENDS, Biospecimen Collection and Vaping - tobacco flavored ENDS in people with Tobacco Cessation and Electronic Nicotine Delivery Systems, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation, Electronic Nicotine Delivery Systems
- What is being tested?
- Vaping - Fruit flavored ENDS, Biospecimen Collection and Vaping - tobacco flavored ENDS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a regular cigarette smoker, defined as >= 5 CPD for at least 12 months. Smoking status will be bio-verified via salivary cotinine (>= 30 ng/mL) and exhaled breath carbon monoxide (CO) > 10 parts per million (ppm) at the baseline visit
- A history of cigarette use for >= 2 years
- Have at least a moderate interest in quitting smoking (defined as >= 4 on a Likert-style 1-10 scale, where 10 represents the greatest interest)
- No regular daily ENDS use in the past 12 months
- Participant (or legal representative) must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study-related procedure
Who cannot join
- Presence of clinically significant health issues or illnesses, including asthma, chronic obstructive pulmonary disease (COPD), or cancer (as self-reported during phone pre-screening and confirmed at baseline visit screening)
- Patients at Roswell Park Comprehensive Cancer Center, regardless of cancer diagnosis status
- Pregnant or nursing female participants (self-reported on telephone screener, self-reported and bio-verified with urinary pregnancy test at baseline visit)
- Use of nicotine products other than cigarettes within 7 days before the baseline visit (self-reported during phone pre-screening and confirmed at the baseline visit)
- Use of any other tobacco products, including cigarillos, cigars, little cigars, or oral nicotine pouches, more than 1 day per week within 30 days before the baseline visit (self-reported during phone pre-screening and confirmed at the baseline visit)
- Use of smoking cessation medications within 3 months before the baseline visit (self-reported during phone pre-screening and confirmed at the baseline visit)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Maciej Goniewicz, 1-877-275-7724, Askroswell@roswellpark.org
ASK ROSWELL, 1-877-275-7724
About this study
Official title: Two-Arm Randomized Clinical Trial of Individuals Who Smoke Tobacco Cigarettes and Initiate ENDS Use With Fruit or Tobacco Flavors (Reducing Smoking With Flavored E-Cigarettes Trial; REFLECT)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Vaping - Fruit flavored ENDS, Biospecimen Collection, Vaping - tobacco flavored ENDS
- Medical subject headings
- Tobacco Use Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaping - Fruit flavored ENDSOther
Receive and use fruit flavored ENDS
Biospecimen CollectionProcedure or surgery
Undergo urine sample collection
Vaping - tobacco flavored ENDSOther
receive and use tobacco flavored ENDS
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Fruit flavored ENDS | Experimental | 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. Receives: Other: Vaping - Fruit flavored ENDS; Procedure: Biospecimen Collection |
| Arm 2 - tobacco flavored ENDS | Experimental | 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. Receives: Procedure: Biospecimen Collection; Other: Vaping - tobacco flavored ENDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cigarettes per day (CPD) from baseline to 12 month follow up visit
CPD reduction at month 12 compared to baseline
Measured: baseline to 12 months
Measure Change in biomarker concentration NNAL
urinary measure of NNAL
Measured: From Baseline to 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline to 12 months
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 start30 Nov 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896330
- Sponsor's protocol ID
- I-5182026
- Other IDs
- R01DA065590
- Acronym
- REFLECT
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Two-Arm Randomized Clinical Trial of Individuals Who Smoke Tobacco Cigarettes and Initiate ENDS Use With Fruit or Tobacco Flavors (Reducing Smoking With Flavored E-Cigarettes Trial; REFLECT)
- ClinicalTrials.gov ID
- NCT07896330
- Acronym / sponsor ID
- REFLECT / I-5182026
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- 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 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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Fruit flavored ENDS | Experimental | Other: Vaping - Fruit flavored ENDS, Procedure: Biospecimen CollectionParticipants 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. |
| Arm 2 - tobacco flavored ENDS | Experimental | Procedure: Biospecimen Collection, Other: Vaping - tobacco flavored ENDSParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be a regular cigarette smoker, defined as >= 5 CPD for at least 12 months. Smoking status will be bio-verified via salivary cotinine (>= 30 ng/mL) and exhaled breath carbon monoxide (CO) > 10 parts per million (ppm) at the baseline visit
- A history of cigarette use for >= 2 years
- Have at least a moderate interest in quitting smoking (defined as >= 4 on a Likert-style 1-10 scale, where 10 represents the greatest interest)
- No regular daily ENDS use in the past 12 months
- Participant (or legal representative) must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study-related procedure
Key exclusion criteria (6 listed)
- Presence of clinically significant health issues or illnesses, including asthma, chronic obstructive pulmonary disease (COPD), or cancer (as self-reported during phone pre-screening and confirmed at baseline visit screening)
- Patients at Roswell Park Comprehensive Cancer Center, regardless of cancer diagnosis status
- Pregnant or nursing female participants (self-reported on telephone screener, self-reported and bio-verified with urinary pregnancy test at baseline visit)
- Use of nicotine products other than cigarettes within 7 days before the baseline visit (self-reported during phone pre-screening and confirmed at the baseline visit)
- Use of any other tobacco products, including cigarillos, cigars, little cigars, or oral nicotine pouches, more than 1 day per week within 30 days before the baseline visit (self-reported during phone pre-screening and confirmed at the baseline visit)
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 |
|---|---|---|
| Vaping - Fruit flavored ENDSReceive and use fruit flavored ENDS | Other | Arm 1 - Fruit flavored ENDS |
| Biospecimen CollectionUndergo urine sample collection | Procedure or surgery | Arm 1 - Fruit flavored ENDS, Arm 2 - tobacco flavored ENDS |
| Vaping - tobacco flavored ENDSreceive and use tobacco flavored ENDS | Other | Arm 2 - tobacco flavored ENDS |
Primary outcome
Change in Cigarettes per day (CPD) from baseline to 12 month follow up visit
Time frame: baseline to 12 months
CPD reduction at month 12 compared to baseline
Measure Change in biomarker concentration NNAL
Time frame: From Baseline to 12 months
urinary measure of NNAL
4 secondary outcomes
Proportion of participants achieving a greater than or equal to 50% reduction in Cigarettes Per Day
Time frame: Baseline to 12 months
Proportion of participants achieving a 100% reduction in CPD
Time frame: Baseline to 12 months
Proportion of participants achieving a greater than or equal to 50% reduction in urinary NNAL
Time frame: Baseline to 12 months
Proportion of participants achieving a 100% reduction in NNAL
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Roswell Park Comprehensive Cancer Center
Buffalo, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaping - Fruit flavored ENDS, Biospecimen Collection and Vaping - tobacco flavored ENDS in people with Tobacco Cessation and Electronic Nicotine Delivery Systems, run by Roswell Park Cancer Institute 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 5 inclusion and 6 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: opening soon, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cigarettes per day (CPD) from baseline to 12 month follow up visit (time frame: baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.