Actively Recruiting
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-06
1500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying cigarette smokers to compare the effects of tobacco-flavored electronic cigarettes (ECs), non-tobacco flavored ECs, and nicotine replacement therapy (NRT) on smoking habits. The study aims to understand how different EC flavors impact appeal, use, cigarette craving, withdrawal symptoms, motivation, and cigarette smoking behavior. The trial is sponsored by Ohio State University Comprehensive Cancer Center and explores how these options may influence smoking dependence and cessation efforts. Participants are randomly assigned to one of three groups: preferred flavor ECs (PEC), tobacco-flavored ECs (TEC), or NRT involving nicotine patches and lozenges. Each group receives their assigned products for 14 weeks, including a 2-week pre-switch period to get familiar with usage. Throughout the study, participants engage in discussions, and after the 14-week treatment period, they enter a 12-week surveillance phase to monitor continued use and outcomes. During the trial, researchers will assess cigarette smoking patterns, including switching rates and abstinence, cigarette craving, withdrawal symptoms, nicotine dependence, and product appeal. Data will be collected at various time points up to 26 weeks. Participants will also be monitored for the number of days they use the products and whether they continue EC use after the treatment phase. The study collects information through questionnaires and biochemical verification, aiming to understand the impact of these interventions on smoking behavior over time.
CONDITIONS
Brief Title
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 21 years old or older
- Smoke at least 5 cigarettes per day for the past year
- Willing to use either an electronic cigarette or nicotine replacement therapy
- Able to read and speak English
- Own a smartphone
You will not qualify if you...
- Currently using smoking cessation medications, nicotine replacement therapy, or actively seeking treatment to quit smoking
- Use an electronic cigarette more than 4 days per month
- Diagnosed with lung disease, asthma, cystic fibrosis, heart disease, or chronic obstructive pulmonary disease (COPD)
- Have an unmanaged diagnosis of schizophrenia
- History of cardiac event or distress within the past 3 months
- Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
- Have uncontrolled high blood pressure
- Experience serious chest pain or angina pectoris
- Stroke within the past three months
- Known allergy to propylene glycol or vegetable glycerin
- Have serious heart rhythm problems or arrhythmias
- Live in the same household as another study participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants become familiar with their assigned product before the full treatment period.
1 baseline visit and weekly visits during run-in
Duration - 14 weeks including the 2-week run-in period
Participants use either preferred flavor e-cigarettes, tobacco-flavored e-cigarettes, or nicotine replacement therapy for smoking cessation.
Weekly visits for up to 14 weeks
Duration - 12 weeks
Participants are followed for monitoring smoking behavior and product use after completing the treatment period.
Periodic follow-up visits during 12-week surveillance
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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