REFLECT
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)
Sponsor study identifier
Secondary identifiers
NIH
interventional
286
1 country
1
Study Start
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2026
Actual (reported)October 27, 2026
Actual (reported)November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Cigarettes per day (CPD) from baseline to 12 month follow up visit
CPD reduction at month 12 compared to baseline
baseline to 12 months
Measure Change in biomarker concentration NNAL
urinary measure of NNAL
From Baseline to 12 months
Proportion of participants achieving a greater than or equal to 50% reduction in Cigarettes Per Day
Baseline to 12 months
Proportion of participants achieving a 100% reduction in CPD
Baseline to 12 months
Proportion of participants achieving a greater than or equal to 50% reduction in urinary NNAL
Baseline to 12 months
Proportion of participants achieving a 100% reduction in NNAL
Baseline to 12 months
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.
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.
Undergo urine sample collection
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
First Submitted
October 20, 2026
First Posted
October 27, 2026
Study Start
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mi QUIT CARE (Mile Square QUIT Community-Access-Referral-Expansion)
receive and use tobacco flavored ENDS
Contact the study team to confirm eligibility.
Primary Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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