Addiction Potential of Very Low Nicotine Filtered Little Cigars

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06630728
Phase
PHASE4
Status
Recruiting
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Conditions

  • Smoking (Tobacco) Addiction

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

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
  • Normal nicotine content cigar — DRUG
    Participants will smoke a normal nicotine content filtered little cigar containing 5.17mg nicotine per gram of tobacco
  • Usual brand cigar — DRUG
    Participants will smoke their usual brand filtered little cigar

Study Details

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.

Key Dates

Start date
Feb 13, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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

Primary Outcome Measure

Drug self-administration- Puff topography- total puff volume [ Time Frame: During session 65 minute puffing session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Dharini M Bhammar, PhD, MBBS
[email protected]
614-366-9467
Lisa Brenner
[email protected]
614-293-7843
Dharini M Bhammar, PhD, MBBS (PRINCIPAL_INVESTIGATOR)
Theodore Wagener, PhD (PRINCIPAL_INVESTIGATOR)

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The Ohio State University· Columbus, OH

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