A Phase 4 interventional study of Reduced Nicotine Content Cigars and Normal nicotine content cigar in Smoking (Tobacco) Addiction, sponsored by Ohio State University Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 4, Interventional, and Basic science
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
268 studies on the registry are indexed under Smoking; 136 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 211 interventional studies indexed under Smoking.
Browse Smoking studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Reduced Nicotine Content Cigars · Drug: Normal nicotine content cigar · Drug: Usual brand cigar
Participants will smoke a very low nicotine content filtered little cigar containing 0.50mg nicotine per gram of tobacco
Also known as: VLNFLC
Participants will smoke a normal nicotine content filtered little cigar containing 5.17mg nicotine per gram of tobacco
Also known as: FLC
Participants will smoke their usual brand filtered little cigar
Also known as: UB
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
Time frame: During session 65 minute puffing session
Forced expiratory volume in 1 second
Spirometry will be completed before and after a 65 min smoking session
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from 0 to 65 minutes
Functional residual capacity
Functional residual capacity will be measured with plethysmography to assess dynamic hyperinflation after the smoking session
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 65 minutes
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ohio State University Comprehensive Cancer Center