NCT06630728

Addiction Potential of Very Low Nicotine Filtered Little Cigars

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-02-13
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2024-10-08
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study