Smoking (Tobacco) AddictionPhase 4LOWFLCNCT06630728
Addiction Potential of Very Low Nicotine Filtered Little Cigars
A Phase 4 study testing Reduced Nicotine Content Cigars, Normal nicotine content cigar and Usual brand cigar in people with Smoking (Tobacco) Addiction, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking (Tobacco) Addiction
- What is being tested?
- Reduced Nicotine Content Cigars, Normal nicotine content cigar and Usual brand cigar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to Jan 2029
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokers: 1) self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use will be defined as >=8 cigars smoked per month based on data showing median cigarillo use is 7.5 times per month and median FLC use is 14 times per month 59. We will attempt to bring in heavier users if feasible during recruitment; or 2) Cigarette smokers (>=8d/month for at least 3 months) with either (i) co-use of filtered little cigars, cigarillos, little cigars, or small cigars (at least once in their lifetime) or (ii) answering "yes" to the question "If all cigarettes were taken off the market, would you consider switching to filtered little cigars?"
- willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
- Willing to bring their own, preferred brand little cigars/ small cigars/ cigarillos/ filtered little cigars to smoke in the lab on the first study visit
- capable of and willing to provide written informed consent
- read and speak in English.
Who cannot join
- Self-reported significant current lung disease (e.g. asthma, COPD, cystic fibrosis, pulmonary fibrosis); exercise-induced asthma, seasonal allergies for which a patient takes inhalers are allowed
- History of diagnosis or treatment for lung cancer
- Self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes)
- History of cardiac event or distress within the past 3 months
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- Substance use disorders besides nicotine addiction
Show all 13Show fewer
- Regular use of other tobacco products besides cigarettes such as snuff, chewing tobacco, snus, e-cigarettes >10d per month
- Exclusive large or premium cigar users
- Use of blunts every time or most of the time
- Regular use of cannabis >10d per month
- Planning to quit in next 30 days or currently trying to quit or quit attempt in past 30 days
- Pregnant, delivery in past 12 weeks, breastfeeding, or planning to get pregnant
- Inability to perform tests or follow instructions during testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Dharini M Bhammar, PhD, MBBS, 614-366-9467, dharini.bhammar@osumc.edu
Dharini M Bhammar, PhD, MBBS
About this study
The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question[s] it aims to answer are:
Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars?
Read more
Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will
- fill several surveys
- provide blood samples
- perform breathing tests
- complete smoking sessions using either their own cigars or the study cigars.
- Conditions
- Smoking (Tobacco) Addiction
- Being tested
- Reduced Nicotine Content Cigars, Normal nicotine content cigar, Usual brand cigar
- Medical subject headings
- Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Nicotine Content CigarsDrug
Also called VLNFLC
Participants will smoke a very low nicotine content filtered little cigar containing 0.50mg nicotine per gram of tobacco
Normal nicotine content cigarDrug
Also called FLC
Participants will smoke a normal nicotine content filtered little cigar containing 5.17mg nicotine per gram of tobacco
Usual brand cigarDrug
Also called UB
Participants will smoke their usual brand filtered little cigar
| Study group | Role | What they receive |
|---|---|---|
| Smoking session | Experimental | All participants will undergo three smoking sessions: one using their own usual brand cigar, one with a normal nicotine study cigar, and one with a reduced nicotine study cigar Receives: Drug: Reduced Nicotine Content Cigars; Drug: Normal nicotine content cigar; Drug: Usual brand cigar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug self-administration- Puff topography- total puff volume
Derived from puff topography, total puff volume indicates the total amount of smoke inhaled during the smoking session. Units: mL
Measured: During session 65 minute puffing session
Forced expiratory volume in 1 second
Spirometry will be completed before and after a 65 min smoking session
Measured: Change from 0 to 65 minutes
Nicotine
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 5 minutes after the smoking session
Measured: Change from 0 to 5 minutes
Nicotine
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 65 minutes after the smoking session
Measured: Change from 0 to 65 minutes
Carbon monoxide boost
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and 5 minutes after the smoking session
Measured: Change from 0 to 5 minutes
Carbon monoxide boost
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and after the smoking session
Measured: Change from 0 to 65 minutes
Secondary outcomes (10)
Functional residual capacity
Functional residual capacity will be measured with plethysmography to assess dynamic hyperinflation after the smoking session
Measured: Change from 0 to 65 minutes
Airway resistance (R5)
Impulse oscillometry will be used to measure total airway resistance before and after the smoking session
Measured: Change from 0 to 65 minutes
Airway resistance (R5-R20)
Impulse oscillometry will be used to measure small airway resistance before and after the smoking session
Measured: Change from 0 to 65 minutes
Modified Cigarette Evaluation Scale
The 12-item modified Cigarette Evaluation Scale will provide subjective effects of smoking cigars on a 0-6-point Likert scale from "not at all" to "extremely". There are five subscales including smoking satisfaction, psychological reward, enjoyment of respiratory symptoms, craving reduction, and aversion
Measured: 65 minutes
Questionnaire on Smoking Urges (Tiffany Drobes)
Smoking urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate smoking-related items (All I want right now is a cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to smoke
Measured: Change from 0 to 5 minutes
Questionnaire on Smoking Urges (Tiffany Drobes)
Smoking urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate smoking-related items (All I want right now is a cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to smoke
Measured: Change from 0 to 65 minutes
Minnesota Nicotine Withdrawal Scale
Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 7 items with scores ranging from 0 to 28 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving.
Measured: Change from 0 to 5 minutes
Minnesota Nicotine Withdrawal Scale
Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 7 items with scores ranging from 0 to 28 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving.
Measured: Change from 0 to 65 minutes
Hypothetical purchase task
Hypothetical purchase task offers a measure of relative reinforcing efficacy. It will be completed after each smoking session. It assesses how many cigars a participant would smoke in a 24-hour period at various hypothetical price conditions and has been used to characterize addiction potential for reduced nicotine content cigars vs. normal nicotine content cigars vs. usual brand cigars. Data from the task leads to five demand indices (intensity or consumption with no cost constraint, price point at which consumption becomes sensitive to price, breakpoint is the price where FLCs are no longer purchased because of high price, largest cost that a participant is willing to incur to purchase FLCs, and elasticity as a measure of the overall sensitivity of FLC consumption to escalating price that measures how behaviors would change under the constraint of increased price).
Measured: 65 minutes
Cross-price task
The Cross-Price Task will estimate the substitutability of the study cigars for the usual brand cigars. It will be completed after each study product smoking session. Participants will be asked how many study products and usual products they would consume when the price of the study product is fixed and the usual product prices escalate. To determine the extent to which each alternative product serves as a substitute for the study product, cross-price elasticities (CPE) will be calculated as the slope of the regression line (B1) fit to the log-transformed mean purchasing of each study product when offered at fixed prices (C) versus log-transformed usual product price (P): logC = B0 + B1logP. CPE for each study product compared to UB product > 0.2 indicates substitution, CPE < -0.2 indicates complementarity, and CPE between -0.2 and 0.2 indicates independence of the two products
Measured: 65 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start13 Feb 2025
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking (Tobacco) AddictionStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dharini Bhammar, Ohio State University Comprehensive Cancer Center
- Investigators
- Dharini M Bhammar, PhD, MBBS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630728
- Sponsor's protocol ID
- 2024C0053
- Acronym
- LOWFLC
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction Potential of Very Low Nicotine Filtered Little Cigars
- ClinicalTrials.gov ID
- NCT06630728
- Acronym / sponsor ID
- LOWFLC / 2024C0053
- Conditions
- Smoking (Tobacco) Addiction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 8 Oct 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.
The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question[s] it aims to answer are:
Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars?
Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will
- fill several surveys
- provide blood samples
- perform breathing tests
- complete smoking sessions using either their own cigars or the study cigars.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking session | Experimental | Drug: Reduced Nicotine Content Cigars, Drug: Normal nicotine content cigar, Drug: Usual brand cigarAll participants will undergo three smoking sessions: one using their own usual brand cigar, one with a normal nicotine study cigar, and one with a reduced nicotine study cigar |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Smokers: 1) self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use will be defined as >=8 cigars smoked per month based on data showing median cigarillo use is 7.5 times per month and median FLC use is 14 times per month 59. We will attempt to bring in heavier users if feasible during recruitment; or 2) Cigarette smokers (>=8d/month for at least 3 months) with either (i) co-use of filtered little cigars, cigarillos, little cigars, or small cigars (at least once in their lifetime) or (ii) answering "yes" to the question "If all cigarettes were taken off the market, would you consider switching to filtered little cigars?"
- willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
- Willing to bring their own, preferred brand little cigars/ small cigars/ cigarillos/ filtered little cigars to smoke in the lab on the first study visit
- capable of and willing to provide written informed consent
- read and speak in English.
Key exclusion criteria (13 listed)
- Self-reported significant current lung disease (e.g. asthma, COPD, cystic fibrosis, pulmonary fibrosis); exercise-induced asthma, seasonal allergies for which a patient takes inhalers are allowed
- History of diagnosis or treatment for lung cancer
- Self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes)
- History of cardiac event or distress within the past 3 months
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
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 |
|---|---|---|
| Reduced Nicotine Content CigarsAlso: VLNFLCParticipants will smoke a very low nicotine content filtered little cigar containing 0.50mg nicotine per gram of tobacco | Drug | Smoking session |
| Normal nicotine content cigarAlso: FLCParticipants will smoke a normal nicotine content filtered little cigar containing 5.17mg nicotine per gram of tobacco | Drug | Smoking session |
| Usual brand cigarAlso: UBParticipants will smoke their usual brand filtered little cigar | Drug | Smoking session |
Primary outcome
Drug self-administration- Puff topography- total puff volume
Time frame: During session 65 minute puffing session
Derived from puff topography, total puff volume indicates the total amount of smoke inhaled during the smoking session. Units: mL
Forced expiratory volume in 1 second
Time frame: Change from 0 to 65 minutes
Spirometry will be completed before and after a 65 min smoking session
Nicotine
Time frame: Change from 0 to 5 minutes
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 5 minutes after the smoking session
Nicotine
Time frame: Change from 0 to 65 minutes
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 65 minutes after the smoking session
Carbon monoxide boost
Time frame: Change from 0 to 5 minutes
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and 5 minutes after the smoking session
Carbon monoxide boost
Time frame: Change from 0 to 65 minutes
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and after the smoking session
10 secondary outcomes
Functional residual capacity
Time frame: Change from 0 to 65 minutes
Airway resistance (R5)
Time frame: Change from 0 to 65 minutes
Airway resistance (R5-R20)
Time frame: Change from 0 to 65 minutes
Modified Cigarette Evaluation Scale
Time frame: 65 minutes
Questionnaire on Smoking Urges (Tiffany Drobes)
Time frame: Change from 0 to 5 minutes
Questionnaire on Smoking Urges (Tiffany Drobes)
Time frame: Change from 0 to 65 minutes
Minnesota Nicotine Withdrawal Scale
Time frame: Change from 0 to 5 minutes
Minnesota Nicotine Withdrawal Scale
Time frame: Change from 0 to 65 minutes
Hypothetical purchase task
Time frame: 65 minutes
Cross-price task
Time frame: 65 minutes
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 29 Oct 2026.
- 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.
The Ohio State University Comprehensive Cancer Center contact
Dharini M Bhammar, PhD, MBBS principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reduced Nicotine Content Cigars, Normal nicotine content cigar and Usual brand cigar in people with Smoking (Tobacco) Addiction, 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 13 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 29 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dharini M Bhammar, PhD, MBBS (614-366-9467, dharini.bhammar@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug self-administration- Puff topography- total puff volume (time frame: During session 65 minute puffing session). The study lists 6 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 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.