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Addiction Potential of Very Low Nicotine Filtered Little Cigars

NCT06630728 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-16

No results posted yet for this study

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

Interventions

DRUG

Reduced Nicotine Content Cigars

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

DRUG

Normal nicotine content cigar

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

DRUG

Usual brand cigar

Participants will smoke their usual brand filtered little cigar

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Dharini M Bhammar, PhD, MBBS · Ohio State University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2027-12-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06630728 on ClinicalTrials.gov