Cigarette Smoking-Related CarcinomaNCT06260683
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
A study testing Nicotine Replacement, Questionnaire Administration and Vaping in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Nicotine Replacement, Questionnaire Administration and Vaping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 12 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >= 21 years old
- Smoke >= 5 cigarettes per day for the past year
- Willing to use either an EC or NRT
- Read and speak English
- Have a smartphone
Who cannot join
- Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
- Current use of an EC > 4 days a month
- Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
- Unmanaged (unmedicated and/or without counseling) 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
Show all 12Show fewer
- High blood pressure not controlled by medications
- Serious angina pectoris or chest pain
- Stroke within the past three months
- Known allergy to propylene glycol or vegetable glycerin
- Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
- Live in same household as another study participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Theodore L. Wagener, PhD, Theodore.Wagener@osumc.edu
Theodore L. Wagener, PhD
About this study
Official title: A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior
This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked.
II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence.
III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
ARM III: Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
Participants in all arms participate in discussions throughout the trial.
SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Nicotine Replacement, Questionnaire Administration, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine ReplacementDrug
Also called Nicotine Replacement Therapy, NRT
Given nicotine patches and nicotine lozenges
Questionnaire AdministrationOther
Ancillary studies
VapingDevice
Also called Vape
Given Preferred Flavor e-liquid
VapingDevice
Also called Vape
Given Tobacco flavored e-liquid
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PEC) | Experimental | Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. Receives: Other: Questionnaire Administration; Device: Vaping |
| Arm II (TEC) | Experimental | Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. Receives: Other: Questionnaire Administration; Device: Vaping |
| Arm III (NRT) | Active comparator | Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. Receives: Drug: Nicotine Replacement; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence complete switching rate
Self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days), any reported use of ECs or NRT over the past 7 days, and an exhaled CO reading of ≤6ppm.
Measured: At week 14
Biochemically verified 7-day point prevalence abstinence from cigarettes
Biochemical verification of abstinence from cigarettes (exhaled CO reading of ≤6ppm) combined with self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days).
Measured: At week 14
Cigarettes smoked per day
Cigarettes smoked per day as evaluated with the timeline follow-back questionnaire.
Measured: At week 14
Secondary outcomes (7)
Change in cigarettes smoked per day
Changes in cigarettes smoked per day from baseline to 26 weeks will be evaluated with the timeline follow-back questionnaire.
Measured: From baseline to 26 weeks
Change in nicotine dependence
Among participants abstaining from smoking, changes in nicotine dependence from baseline to 14 weeks will be assessed in the PEC, TEC, and NRT arms with the PROMIS nicotine dependence scale. Scores range from 0 to 16 with higher scores indicating greater dependence.
Measured: From baseline to 14 weeks
Changes in cigarette craving and nicotine withdrawal
Cigarette craving and nicotine withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS). Total MPSS scores range from 12 to 60 with higher scores indicating a greater severity of tobacco withdrawal symptoms.
Measured: At baseline, 2, 6, 14, and 26 weeks
Number of days used in past week
The number of days the study products are used in the past 7 days during the period of product provision in the PEC and TEC arms.
Measured: At 2, 6, and 14 weeks
Number of days used in past month
The number of days the study products are used in the past 30 days during the period of product provision in the PEC and TEC arms.
Measured: At 6 and 14 weeks
Product appeal
EC appeal is measured with the modified Cigarette Evaluation Questionnaire (mCEQ) to assess subjected responses to ECs (e.g., reward, satisfaction).
Measured: At 2, 6, 14, and 26 weeks
Continued use of ECs
The proportion of participants who continue to use ECs between 14 and 26 weeks in the PEC and TEC arms.
Measured: From 14 to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start10 Apr 2024
- Primary completion12 Apr 2028 (estimated)
- Study completion12 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Theodore Wagener, Ohio State University Comprehensive Cancer Center
- Investigators
- Theodore L Wagener, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260683
- Sponsor's protocol ID
- OSU-22240
- Other IDs
- NCI-2023-04102, R01DA057327
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior
- ClinicalTrials.gov ID
- NCT06260683
- Acronym / sponsor ID
- OSU-22240
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 12 Apr 2028 (estimated)
- Study completion
- 12 Apr 2028 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.
Detailed description
PRIMARY OBJECTIVES:
- Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked.
II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence.
III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
ARM III: Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
Participants in all arms participate in discussions throughout the trial.
SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (PEC) | Experimental | Other: Questionnaire Administration, Device: VapingParticipants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. |
| Arm II (TEC) | Experimental | Other: Questionnaire Administration, Device: VapingParticipants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. |
| Arm III (NRT) | Active comparator | Drug: Nicotine Replacement, Other: Questionnaire AdministrationParticipants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= 21 years old
- Smoke >= 5 cigarettes per day for the past year
- Willing to use either an EC or NRT
- Read and speak English
- Have a smartphone
Key exclusion criteria (12 listed)
- Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
- Current use of an EC > 4 days a month
- Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
- Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
- History of cardiac event or distress within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine ReplacementAlso: Nicotine Replacement Therapy, NRTGiven nicotine patches and nicotine lozenges | Drug | Arm III (NRT) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (PEC), Arm II (TEC), Arm III (NRT) |
| VapingAlso: VapeGiven Preferred Flavor e-liquid | Device | Arm I (PEC) |
| VapingAlso: VapeGiven Tobacco flavored e-liquid | Device | Arm II (TEC) |
Primary outcome
7-day point prevalence complete switching rate
Time frame: At week 14
Self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days), any reported use of ECs or NRT over the past 7 days, and an exhaled CO reading of ≤6ppm.
Biochemically verified 7-day point prevalence abstinence from cigarettes
Time frame: At week 14
Biochemical verification of abstinence from cigarettes (exhaled CO reading of ≤6ppm) combined with self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days).
Cigarettes smoked per day
Time frame: At week 14
Cigarettes smoked per day as evaluated with the timeline follow-back questionnaire.
7 secondary outcomes
Change in cigarettes smoked per day
Time frame: From baseline to 26 weeks
Change in nicotine dependence
Time frame: From baseline to 14 weeks
Changes in cigarette craving and nicotine withdrawal
Time frame: At baseline, 2, 6, 14, and 26 weeks
Number of days used in past week
Time frame: At 2, 6, and 14 weeks
Number of days used in past month
Time frame: At 6 and 14 weeks
Product appeal
Time frame: At 2, 6, 14, and 26 weeks
Continued use of ECs
Time frame: From 14 to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theodore L Wagener, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement, Questionnaire Administration and Vaping in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence complete switching rate (time frame: At week 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.