Flavored Vaping for Tobacco Cessation

(REFLECT Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults who currently smoke cigarettes and are interested in reducing or quitting smoking. Participants should be willing to try electronic nicotine delivery systems (vapes) with either fruit or tobacco flavors.

Inclusion Criteria

Be a regular cigarette smoker, defined as >= 5 CPD for at least 12 months, with smoking status bio-verified via salivary cotinine (>= 30 ng/mL) and exhaled breath carbon monoxide (CO) > 10 ppm at baseline visit
Have a history of cigarette use for >= 2 years
No regular daily ENDS use in the past 12 months
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Exclusion Criteria

Patients at Roswell Park Comprehensive Cancer Center regardless of cancer diagnosis status
I have a serious health condition like asthma, COPD, or cancer.
Use of nicotine products other than cigarettes within 7 days before baseline visit as self-reported and confirmed
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What Are the Treatments Tested in This Trial?

Trial Overview

The study compares the effects of using fruit-flavored versus tobacco-flavored vaping devices (ENDS) on cigarette use and exposure to harmful substances. Biospecimen samples will be collected to measure changes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm 2 - tobacco flavored ENDSExperimental Treatment2 Interventions
Group II: Arm 1 - Fruit flavored ENDSExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+