Addiction Potential of Very Low Nicotine Filtered Little Cigars

NCT06630728 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024C0053
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking (Tobacco) Addiction

Outcome Measures

Primary Outcomes (6)

• 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

  During session 65 minute puffing session

• Forced expiratory volume in 1 second

  Spirometry will be completed before and after a 65 min smoking session

  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

  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

  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

  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

  Change from 0 to 65 minutes

Secondary Outcomes (10)

• Functional residual capacity

  Change from 0 to 65 minutes

• Airway resistance (R5)

  Change from 0 to 65 minutes

• Airway resistance (R5-R20)

  Change from 0 to 65 minutes

• Modified Cigarette Evaluation Scale

  65 minutes

• Questionnaire on Smoking Urges (Tiffany Drobes)

  Change from 0 to 5 minutes

Study Arms (1)

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

Drug: Reduced Nicotine Content Cigars; Drug: Normal nicotine content cigar; Drug: Usual brand cigar

Interventions

Reduced Nicotine Content Cigars DRUG

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

Also known as: VLNFLC

Smoking session

Normal nicotine content cigar DRUG

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

Also known as: FLC

Smoking session

Usual brand cigar DRUG

Participants will smoke their usual brand filtered little cigar

Also known as: UB

Smoking session

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Smoking; Behavior, Addictive

Condition Hierarchy (Ancestors)

Behavior; Compulsive Behavior; Impulsive Behavior

Study Officials

• Dharini M Bhammar, PhD, MBBS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dharini M Bhammar, PhD, MBBS

CONTACT

614-366-9467; dharini.bhammar@osumc.edu

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)