A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers

Stopped early · Not applicable

Conditions studied: Smoking, Tobacco

In brief

The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, or non-tobacco/non-menthol-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.

Key facts

Study ID

NCT07172438

Run by

RAI Services Company

People needed

668

Starts

2025-09-17

Expected to finish

2026-01-14

Last updated by the study team

2026-02-27

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English
• Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent
• All female (assigned at birth) candidate participants who agree during the pre-screener to receive and take a home pregnancy test prior to the SEV, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
• NOTE: Participants who identify as "intersex" or "unknown" during screening, will be offered the opportunity to receive a pregnancy test if they wish to take one.
• Currently smoke at least 10 cigarettes on smoking days in the past 30 days
• Smoke cigarettes regularly for at least 12 months
• Smoke cigarettes on 15 or more of the past 30 days
• Smoked at least 100 cigarettes in their lifetime prior to the screening and enrollment visit.
• Must indicate smoking factory-made filtered menthol and/or non-menthol cigarettes as their primary nicotine product (Occasional use of other tobacco- or nicotine-containing products is acceptable)
• Indicate a willingness to use ENDS
• Agree to participate in the study and to abide by the study restrictions and requirements, as described in the informed concent form (ICF)

You may not qualify if…

• Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
• Female participants who self-report not using adequate methods to prevent pregnancy
• Persons with pacemakers or other embedded electronic medical devices fitted
• Persons who self-report heart disease, high blood pressure, diabetes, cancer, Chronic Obstructive Pulmonary Disease, emphysema, asthma or other lung/breathing conditions, a previous history of heart attack or stroke, or are taking medication for depression.
• Persons who self-report they are allergic/sensitive to cosmetics or fragrances or to any ingredient listed in Vuse commercial products or similar products, including those listed below:
• Carvone (L-)
• Benzyl alcohol
• Participants who have used ENDS, nicotine pouch or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products on 5 or more days in the past 30 days
• Participants who have used ENDS, nicotine pouch or smokeless tobacco products more than 100 times in their lifetime
• Participants who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
• Employee of a company that manufactures tobacco or ENDS products
• Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products
• Have taken part in a tobacco/nicotine research study in the past 30 days

Where it is running

• CRG Test America-Phoenix — Chandler, Arizona, United States
• C&C-Fort Smith — Fort Smith, Arkansas, United States
• Research America Orlando — Altamonte Springs, Florida, United States
• C&C-Tampa — Clearwater, Florida, United States
• Sago Orlando — Maitland, Florida, United States
• CRG Test America-Pembroke Pines — Miami, Florida, United States
• CRG Test America-Ormond Beach — Ormond Beach, Florida, United States
• C&C-Plantation — Plantation, Florida, United States
• C&C-Sebring — Sebring, Florida, United States
• C&C-Tallahassee — Tallahassee, Florida, United States
• CRG Test America-Tampa — Tampa, Florida, United States
• C&C-Lombard — Lombard, Illinois, United States
• C&C-Troy — Troy, Michigan, United States
• CRG Test America-St. Peters — City of Saint Peters, Missouri, United States
• C&C-Richmond Heights — St Louis, Missouri, United States
• Sago St. Louis — St Louis, Missouri, United States
• Sago Philadelphia — Philadelphia, Pennsylvania, United States
• C&C-Philadelphia — Philadelphia, Pennsylvania, United States
• Southern Solutions Knoxville — Knoxville, Tennessee, United States
• C&C-Arlington — Arlington, Texas, United States
• Sago Dallas — Dallas, Texas, United States
• CRG Test America-Grapevine — Grapevine, Texas, United States
• Sago Houston — Houston, Texas, United States
• C&C-Humble — Humble, Texas, United States
• C&C-Mesquite — Mesquite, Texas, United States

Full record on ClinicalTrials.gov

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