50 Participants Needed

Reduced Nicotine Cigars for Smoking Addiction

(LOWFLC Trial)

DM
TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must abstain from all tobacco and nicotine for at least 12 hours before lab sessions.

What data supports the effectiveness of the treatment Reduced Nicotine Content Cigars for smoking addiction?

Research on reduced nicotine content cigarettes shows that lowering nicotine levels can decrease the demand for smoking and reduce the addiction potential without increasing smoking intensity. This suggests that similar reduced nicotine content cigars might help people smoke less and reduce their addiction.12345

Is it safe to use reduced nicotine cigars for smoking addiction?

There is no specific safety data available for reduced nicotine cigars, but some studies suggest that reduced nicotine products may deliver less harmful substances compared to regular tobacco products. However, it's important to note that little cigars and cigarillos are likely as dangerous as cigarettes, and more research is needed to fully understand their safety.16789

How do reduced nicotine content cigars differ from other smoking addiction treatments?

Reduced nicotine content cigars are unique because they aim to lower nicotine intake while still providing the sensory experience of smoking, which can help reduce cravings and support smoking cessation. Unlike traditional methods that focus solely on nicotine replacement or cessation aids, this approach addresses both the physical and psychological aspects of smoking addiction.13101112

What is the purpose of this trial?

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.

Research Team

DM

Dharini M Bhammar, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for adult smokers who regularly use filtered little cigars. Participants must be willing to attend three study visits at OSU, which include surveys, blood samples, breathing tests, and smoking sessions with different types of cigars.

Inclusion Criteria

Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
Read and speak in English
Self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use 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
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Exclusion Criteria

I have been diagnosed or treated for lung cancer.
Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
Substance use disorders besides nicotine addiction
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend three study visits at OSU, each lasting up to 4 hours, to complete surveys, provide blood samples, perform breathing tests, and participate in smoking sessions using either their own cigars or the study cigars.

3 visits
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Reduced Nicotine Content Cigars
Trial Overview The trial is testing the effects of reducing nicotine in little cigars on users' behavior and lung health. It compares regular user-preferred cigars with normal nicotine content study cigars and very low nicotine content study cigars over three visits.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Smoking sessionExperimental Treatment3 Interventions
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Findings from Research

Reducing nicotine levels in cigarettes could significantly lower tobacco-related health issues, and this approach is supported by regulatory frameworks like the U.S. Family Smoking Prevention and Tobacco Control Act.
Key research gaps were identified, such as determining the optimal nicotine dose for reducing smoking, understanding the role of other tobacco constituents, and assessing potential unintended consequences of nicotine reduction strategies.
Nicotine reduction: strategic research plan.Hatsukami, DK., Benowitz, NL., Donny, E., et al.[2021]

References

Refined cigarette smoke as a method for reducing nicotine intake. [2023]
Effect of incorporating a 10 minute point of care test for salivary nicotine metabolites into a general practice based smoking cessation programme: randomised controlled trial. [2018]
Nicotine reduction: strategic research plan. [2021]
Response to reduced nicotine content cigarettes among smokers differing in tobacco dependence severity. [2022]
Effects of low nicotine content cigarettes on smoke intake. [2015]
Little cigars, big cigars: omissions and commissions of harm and harm reduction information on the Internet. [2023]
A Focus Group Study of Reactions to Messages about a Nicotine Reduction Policy Among People Who Use Little Cigars and Cigarillos. [2023]
Tobacco harm reduction: Past history, current controversies and a proposed approach for the future. [2023]
"I Crave a Blunt, I Don't Crave a Cigarillo": A Focus Group Study on Perceptions of Nicotine and Addiction among US Adults Who Currently Smoke Little Cigars or Cigarillos. [2023]
Paying more attention to the 'elephant in the room'. [2018]
Effects of motivation phase intervention components on quit attempts in smokers unwilling to quit: A factorial experiment. [2020]
Reduced-nicotine content cigarettes: Is there potential to aid smoking cessation? [2015]
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