Actively Recruiting
A Randomized Controlled Trial to Determine the Effect of Flavor Availability on Smoking Abstinence Using an Electronic Nicotine Delivery System in Adult Combustible Cigarette Smokers
Led by RAI Services Company · Updated on 2026-06-03
1280
Participants Needed
7
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the availability of different flavors in electronic nicotine delivery systems (ENDS) affects smoking abstinence among adult smokers of combustible cigarettes. This open-label, randomized controlled trial focuses on healthy adults aged 21 to 65 who currently use combustible cigarettes. The study aims to assess whether access to tobacco-flavored, menthol-flavored, mint, or other flavored e-liquids influences participants' ability to stop smoking their usual cigarettes over a 13-week period. Participants will be randomly assigned to one of three groups with varying flavor options: one group can choose tobacco and two non-tobacco/non-menthol/mint flavors, another can choose tobacco, mint, and menthol flavors, and the last group will have access only to tobacco flavor. All groups will use an ENDS device with a 5% nicotine level. The study starts with a one-week trial period for flavor sampling, followed by regular visits on Days 0, 30, 60, and 90. Some groups have optional visits in the first 4 weeks to try different flavors within their assigned options. Participants can use the ENDS and any other tobacco or nicotine products as they wish during the study. Participants will complete daily, weekly, and monthly surveys via a smartphone app, reporting cigarette use, flavor preferences, product satisfaction, quit attempts, and other factors influencing their smoking habits. The ENDS device will record usage patterns such as puff duration and intervals. Safety and adverse events will be monitored through a hotline throughout the study. The primary outcome is smoking abstinence during the final 7 days of the 13-week period. After study completion, participants return for a close-out visit and are discharged from the study.
CONDITIONS
Brief Title
A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and sign informed consent and complete questionnaires in English
- Generally healthy male or female aged 21 to 65 inclusive at consent
- Female or intersex participants agree to pregnancy testing and are not pregnant or intending pregnancy
- Currently smoke at least 5 combustible cigarettes on smoking days in past 30 days
- Smoke combustible cigarettes on 15 or more of the past 30 days
- Smoked at least 100 factory-made combustible cigarettes in lifetime prior to screening
- Willing to use electronic nicotine delivery system (ENDS)
- Own and regularly use a smartphone with internet access for study app
- Agree to participate and follow study requirements as described in consent form
You will not qualify if you...
- Pregnant or breastfeeding females or planning pregnancy or breastfeeding within next 6 months
- Male participants unwilling to use contraception or refrain from sperm donation unless vasectomized or partner unable to bear children
- Female participants not using adequate pregnancy prevention methods
- Persons with pacemakers or embedded electronic medical devices
- Participants with unstable heart conditions, severe hypertension, or diabetes
- Persons allergic or sensitive to cosmetics, fragrances, or ingredients in e-cigarette products
- Participants reporting poor physical or mental health
- Recent use (5 or more days in past 30) of ENDS, nicotine pouches, smokeless tobacco, heated tobacco, other combustible or oral nicotine products
- Recent use (past 30 days) of nicotine replacement therapy or prescription smoking cessation drugs
- Participants without a compatible smartphone
- Employees or persons with close relations in litigation with tobacco or ENDS manufacturers
- Participation in tobacco/nicotine research studies within past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 months before enrollment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 1 week
Participants sample the available flavors within their assigned study arm and begin using the electronic nicotine delivery system (ENDS).
1 visit on Day 0 (in-person)
Duration - 13 weeks
Participants use ENDS with assigned flavors over the 13-week study period, with the option to change flavors based on their study arm. They are monitored for smoking abstinence and product use.
Site visits on Days 0, 7 (optional for some arms), 14 (optional for some arms), 21 (optional for some arms), 30, 60, and 90 (all in-person)
Duration - At study end (Day 90)
Participants return to the site for study close-out and discharge. Safety and adverse events are monitored throughout the study.
1 visit (in-person)
Trial Site Locations
Total: 7 locations
1
Sago Orlando
Maitland, Florida, United States, 32751
Actively Recruiting
2
Sago Atlanta
Atlanta, Georgia, United States, 30328
Actively Recruiting
3
Sago St. Louis
St Louis, Missouri, United States, 63131
Actively Recruiting
4
L&E Raleigh
Raleigh, North Carolina, United States, 27612
Actively Recruiting
5
Sago Philadelphia
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
6
Sago Dallas
Dallas, Texas, United States, 75254
Actively Recruiting
7
Sago Houston
Houston, Texas, United States, 77027
Actively Recruiting
Research Team
M
Montgomery E. Hedgecock
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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