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Addiction Potential of Very Low Nicotine Filtered Little Cigars

Study acronym: LOWFLC
StatusRecruiting
PhasePhase 4
Started2025-02-13
View on ClinicalTrials.gov ↗

Amendment history

2025-10-15
Study Status, Eligibility v6
Eligibility criteria+38 characters
[...] ring in heavier users if feasible during recruitment; or 2) Dual-users: cigaretteCigarette smokers (>=20d8d/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 pastquestion 3"If months)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 lea [...] ettes >10d per month Exclusive large or premium cigar users Zero use of filtered little cigars, cigarillos, little cigars, [...] [...]
2025-06-06
Study Status, Oversight, Study Design, Arms and Interventions v5
PhaseNot applicable→Phase 4
InterventionsNormal nicotine content cigar (Behavioral), Reduced Nicotine Content Cigars (Behavioral), Usual brand cigar (Behavioral)→Normal nicotine content cigar (Drug), Reduced Nicotine Content Cigars (Drug), Usual brand cigar (Drug)
2025-05-30
Study Status, Oversight, Study Design, Arms and Interventions, Eligibility v4
PhaseNot specified→Not applicable
2025-05-13
Study Status, Oversight, Study Design, Arms and Interventions, Eligibility v3
PhaseNot applicable→Not specified
Enrollment target30→50
Eligibility criteria+462 characters
Inclusion Criteria: 21-55Smokers: years1) old in age self-reported regular current filtered little cigars, cigari [...] 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) Dual-users: cigarette smokers (>=20d/month for at least 3 months) with co-use of filtered little cigars, cigarillos, little cigars, or small cigars (at least once in the past 3 months) 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 [...] [...]
2025-03-25
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-05→confirmed 2025-02-13
Study sitesdetails revised at 1 of 1 site
2025-02-03
Study Status v1
Start date2025-01-05→2025-03-05
2024-10-04
Original filing
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.
Trial Details
NCT Number NCT06630728
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Smoking (Tobacco) Addiction
Enrollment 50 participants
Start Date 2025-02-13
Primary Completion 2027-12 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-16