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NCT Number: NCT06630728

Addiction Potential of Very Low Nicotine Filtered Little Cigars

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Dharini M Bhammar, PhD, MBBS

CONTACT

[email protected]

614-366-9467

Dharini M Bhammar, PhD, MBBS

PRINCIPAL_INVESTIGATOR

Lisa Brenner

CONTACT

[email protected]

614-293-7843

Theodore Wagener, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Reduced Nicotine Content Cigars

Drug

Participants will smoke a very low nicotine content filtered little cigar containing 0.50mg nicotine per gram of tobacco

Other names: VLNFLC

Normal nicotine content cigar

Drug

Participants will smoke a normal nicotine content filtered little cigar containing 5.17mg nicotine per gram of tobacco

Other names: FLC

Usual brand cigar

Drug

Participants will smoke their usual brand filtered little cigar

Other names: UB

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Functional residual capacity

    Time frame: Change from 0 to 65 minutes

    Functional residual capacity will be measured with plethysmography to assess dynamic hyperinflation after the smoking session

  2. Airway resistance (R5)

    Time frame: Change from 0 to 65 minutes

    Impulse oscillometry will be used to measure total airway resistance before and after the smoking session

  3. Airway resistance (R5-R20)

    Time frame: Change from 0 to 65 minutes

    Impulse oscillometry will be used to measure small airway resistance before and after the smoking session

  4. Modified Cigarette Evaluation Scale

    Time frame: 65 minutes

    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

  5. Questionnaire on Smoking Urges (Tiffany Drobes)

    Time frame: Change from 0 to 5 minutes

    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

  6. Questionnaire on Smoking Urges (Tiffany Drobes)

    Time frame: Change from 0 to 65 minutes

    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

  7. Minnesota Nicotine Withdrawal Scale

    Time frame: Change from 0 to 5 minutes

    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.

  8. Minnesota Nicotine Withdrawal Scale

    Time frame: Change from 0 to 65 minutes

    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.

  9. Hypothetical purchase task

    Time frame: 65 minutes

    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).

  10. Cross-price task

    Time frame: 65 minutes

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dharini M Bhammar, PhD, MBBS

CONTACT

[email protected]

614-366-9467

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Acronym: LOWFLC

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 8, 2024
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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