Recruiting

Nicotine Reduction

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06630728

Conditions

Smoking (Tobacco) Addiction

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Reduced Nicotine Content Cigars

Normal nicotine content cigar

Usual brand cigar

Study Details

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

Study ID

NCT06630728

Start date

Feb 13, 2025

Status verified date

Oct, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Smoking session

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

Interventions

Reduced Nicotine Content Cigars

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

Normal nicotine content cigar

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

Usual brand cigar

Participants will smoke their usual brand filtered little cigar

Primary outcome measure

  • Drug self-administration- Puff topography- total puff volume [ Time Frame: During session 65 minute puffing session ]
  • Forced expiratory volume in 1 second [ Time Frame: Change from 0 to 65 minutes ]
  • Nicotine [ Time Frame: Change from 0 to 5 minutes ]
  • Nicotine [ Time Frame: Change from 0 to 65 minutes ]
  • Carbon monoxide boost [ Time Frame: Change from 0 to 5 minutes ]
  • Carbon monoxide boost [ Time Frame: Change from 0 to 65 minutes ]

Central Contacts and Locations

Central contacts

Dharini M Bhammar, PhD, MBBS

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

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Dharini M Bhammar, PhD, MBBS

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

Lisa Brenner

614-293-7843Lisa.Brenner@osumc.edu

Principal Investigator:

Dharini M Bhammar, PhD, MBBS

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Oct 16, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2025-10-16.