Reduced Nicotine Cigars for Smoking Addiction

(LOWFLC Trial)

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Lung disease, Lung cancer, Kidney disease, Liver disease, Metabolic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3 visits

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how reducing nicotine in cigars affects smoking habits and lung health. Researchers seek to determine if smoking behaviors, satisfaction, and health effects change when using cigars with varying nicotine levels. Participants will smoke their usual cigars and try study cigars with normal and very low nicotine levels (reduced nicotine content cigars). Ideal candidates are adults who smoke at least eight filtered little cigars per month and can abstain from tobacco for 12 hours before visits. As a Phase 4 trial, this research involves an FDA-approved treatment and helps to understand its benefits for more patients.

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 is the safety track record for reduced nicotine content cigars?

Research has shown that lowering nicotine in cigarettes can help people smoke less and experience fewer cravings, potentially reducing the harm caused by smoking. Although specific safety information for cigars with less nicotine is lacking, studies suggest that products with reduced nicotine might be safer than regular ones. The trial's later stage indicates that earlier studies have already provided some safety information, suggesting the treatment is likely safe. However, participants should always consult the study team for detailed safety information. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about reduced nicotine content cigars because they offer a novel approach to addressing smoking addiction. Unlike traditional cigars, which contain higher levels of nicotine and can reinforce addiction, these cigars contain less nicotine, potentially reducing dependency. By cutting down nicotine intake while maintaining the ritual of smoking, this method aims to help smokers gradually lessen their addiction. This unique approach could provide a significant advantage over current cessation methods like nicotine replacement therapies or medications, offering a more natural transition away from high nicotine consumption.

What evidence suggests that reduced nicotine content cigars could be effective for smoking addiction?

Research has shown that lowering nicotine in cigarettes makes them much less addictive, potentially reducing the number of people who become addicted smokers. In this trial, participants will smoke their usual brand cigar, a normal nicotine study cigar, and a reduced nicotine study cigar. Studies indicate that using cigarettes with less nicotine can lead to smoking less, as people tend to take fewer puffs. Evidence also suggests that lower nicotine levels reduce exposure to harmful substances. Overall, these reduced nicotine cigars could help decrease addiction and improve lung health. ^{1 2 6 7 8}

Who Is on the Research Team?

Dharini M Bhammar, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Smoking session Experimental Treatment 3 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

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine reduction: strategic research plan. Hatsukami, DK., Benowitz, NL., Donny, E., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4565734/

Effect of Reducing the Nicotine Content of Cigarettes on ... (1) When nicotine levels get very low, cigarettes would be much less addictive. As a result, fewer young people would become addicted adult smokers; and ...

2. tobaccofreekids.org tobaccofreekids.org/us-resources/fact-sheet/reducing-nicotine-in-cigarettes-will-reduce-addiction-and-save-lives

Reducing Nicotine in Cigarettes Will Reduce Addiction and ... Research demonstrates that significantly reducing nicotine levels holds great promise for accelerating progress in reducing smoking. Scientific evidence ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773065425001361

Influence of tobacco use patterns on smoking cessation ... Dual use of cigars and cigarettes comprised 3.7%, while dual use of electronic nicotine delivery systems (ENDS) and cigarettes made up 4.4%.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06630728

Addiction Potential of Very Low Nicotine Filtered Little Cigars 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.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2698078

Association of Reduced Nicotine Content Cigarettes With ... Use of reduced nicotine content cigarettes for two 15-day periods was associated with decreased puffing behaviors and urinary tobacco biomarker exposure.

6. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2649276

Addiction Potential of Cigarettes With Reduced Nicotine ... Overall, the present findings are consistent with the lower smoking rates, decreased nicotine dependence severity, increased quit attempts, and ...

7. withpower.com withpower.com/trial/phase-smoking-tobacco-addiction-2025-16162

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 ...

8. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(24)00123-6/fulltext

Reduced nicotine in cigarettes in a marketplace with ... This study demonstrates that VLNC cigarettes result in better smoking-related outcomes than NNC cigarettes, that the uptake of non-combusted ANDS is greater in ...