A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers
NCT ID: NCT07172438
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1950 participants
INTERVENTIONAL
2025-09-17
2026-12-31
Brief Summary
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Detailed Description
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Potential participants will be recruited and enrolled at 27 sites across the United States. Ipsos will recruit participants in person (e.g., through mall intercepts) at each site or by telephone from existing databases of previous research participants. Based on meeting eligibility requirements, participants will be required to read and sign an Informed Consent Form and to attend a site visit to complete enrollment.
At the Enrollment Visit, participants will be randomized to one of the three study arms. All participants will begin the study with a one-week Trial Period. This Trial Period will allow participants to sample the available flavor(s) within their assigned study arm.
All participants will attend mandatory follow-up site visits on Day 0, Day 30, Day 60, and Day 90, with the option of changing to a different flavor among the available flavors based upon their assigned study arm, if applicable. In the first four weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits on Day 7, Day 14, and Day 21, with the option of changing flavors among those available in their assigned study arm. All site visits will record the number of study investigational product cartridges dispensed, in addition to all used and unused investigational product cartridges returned.
During the three-month ambulatory study period, participants will be free to use the study investigational product and any other tobacco or nicotine products as desired. The electronic nicotine delivery system (Version 2) power unit technology will measure their puffing topography during use (including puff duration and the time interval between puffs). The puffing topography data will be automatically transferred to a secure online database via a Bluetooth transfer application using the provided smartphone.
Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on the provided smartphone. Surveys will collect data on:
1. The number of cigarettes smoked the previous day
2. Current flavor use
3. Product liking
4. Number of cigarette quit attempts
5. Use of other tobacco or nicotine products
6. Intent to substitute their usual brand combustible cigarettes for the study investigational product (e.g., gradual, complete, or future intent)
7. Social and environmental factors influencing switching intent
At the conclusion of the ambulatory study period, all participants will return to the study sites for a close-out period and will then be discharged from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Tobacco, Menthol, Non Tobacco Non Menthol Flavors
Participants can choose between tobacco, menthol, and non-tobacco non-menthol flavor variants at one nicotine level (5%).
P2611222
Menthol flavor
P2615022
Non-tobacco non-menthol flavor
P2615122
Non-tobacco non-menthol flavor
P2613422
Tobacco flavor
Tobacco and Menthol Flavor
Participants can choose between tobacco and menthol flavor variants at one nicotine level (5%).
P2611222
Menthol flavor
P2613422
Tobacco flavor
Tobacco Flavor
Participants can use a tobacco flavor variant at one nicotine level (5%).
P2613422
Tobacco flavor
Interventions
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P2611222
Menthol flavor
P2615022
Non-tobacco non-menthol flavor
P2615122
Non-tobacco non-menthol flavor
P2613422
Tobacco flavor
Eligibility Criteria
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Inclusion Criteria
2. Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent
3. 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.
4. Currently smoke at least 10 cigarettes on smoking days in the past 30 days
5. Smoke cigarettes regularly for at least 12 months
6. Smoke cigarettes on 15 or more of the past 30 days
7. Smoked at least 100 cigarettes in their lifetime prior to the screening and enrollment visit.
8. 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)
9. Indicate a willingness to use ENDS
10. Agree to participate in the study and to abide by the study restrictions and requirements, as described in the informed concent form (ICF)
Exclusion Criteria
2. Female participants who self-report not using adequate methods to prevent pregnancy
3. Persons with pacemakers or other embedded electronic medical devices fitted
4. 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.
5. 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:
1. Carvone (L-)
2. Benzyl alcohol
6. 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
7. Participants who have used ENDS, nicotine pouch or smokeless tobacco products more than 100 times in their lifetime
8. 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.
9. Employee of a company that manufactures tobacco or ENDS products
10. Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products
11. Have taken part in a tobacco/nicotine research study in the past 30 days
21 Years
65 Years
ALL
Yes
Sponsors
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RAI Services Company
INDUSTRY
Responsible Party
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Principal Investigators
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Melissa Tapia, Ph.D.
Role: STUDY_DIRECTOR
RAIS Service Co
Locations
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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
C&C-San Antonio
San Antonio, Texas, United States
C&C-San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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PHCB3US20256
Identifier Type: -
Identifier Source: org_study_id
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