Low Nicotine Cigarettes for Smoking

Overseen By Madeleine Mason, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Tobacco cessation

Disqualifiers: Pregnancy, Unstable health, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how low-nicotine cigarettes (Low Nicotine Standard) and changes in tobacco prices influence buying habits and the use of alternatives like e-cigarettes. The goal is to understand whether smokers might switch to illegal products or other nicotine sources when faced with these changes. It involves two groups: those who only smoke cigarettes and those who use both cigarettes and e-cigarettes. The trial suits individuals who smoke at least 10 cigarettes a day and have stable smoking habits. As an unphased trial, it provides a unique opportunity to contribute to research that could shape future tobacco policies.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take any tobacco cessation medications or medications that interfere with nicotine metabolism, motivation, or reinforcement.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low nicotine cigarettes are generally easy for people to use. In earlier studies, individuals who smoked very-low-nicotine cigarettes (VLNC) smoked fewer cigarettes daily and had lower carbon monoxide levels in their breath, indicating reduced intake of harmful chemicals. They also reported fewer cravings and found smoking less enjoyable.

Another study found that people using VLNC cigarettes had better overall outcomes related to smoking compared to those using regular nicotine cigarettes. This suggests that the low nicotine version is safe to use and might even help reduce smoking habits.

These findings indicate that VLNC cigarettes are a safe choice for those wanting to lower their nicotine intake. However, consulting a healthcare provider before changing smoking habits is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for low nicotine cigarettes because it explores a novel approach to smoking cessation. Unlike conventional cigarettes, which contain higher levels of nicotine, these low nicotine options aim to reduce nicotine dependence by delivering significantly less nicotine. This could potentially lead to decreased addiction levels and make it easier for smokers to quit. Additionally, by examining the impact of tobacco pricing, researchers hope to understand how financial factors might influence smoking habits. This dual approach could offer fresh insights into reducing smoking rates more effectively than current methods.

What evidence suggests that this trial's treatments could be effective for smoking?

Research has shown that lowering nicotine levels in cigarettes makes them much less addictive. In this trial, participants will use low nicotine cigarettes. Studies have found that cigarettes with very low nicotine (VLNCs) increase the confidence of smokers who want to quit, often leading to better success in quitting. Smokers who switch to VLNCs also tend to smoke fewer cigarettes over time. The aim is to reduce reliance on nicotine, which can help decrease overall smoking rates. ^{2 6 7 8 9}

Who Is on the Research Team?

Roberta Freitas-Lemos, PhD

Principal Investigator

Fralin Biomedical Research Institute at Virginia Tech Carilion

Are You a Good Fit for This Trial?

This trial is for individuals who use cigarettes or e-cigarettes. Specific eligibility criteria are not provided, but typically participants must be of legal smoking age and may need to meet certain health conditions.

Inclusion Criteria

Provide informed consent

Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)

Stable tobacco use patterns for at least two months

Exclusion Criteria

For both groups: Have plans to move out of the area

Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study

Being pregnant or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Participants complete an assessment session to evaluate baseline characteristics and preferences

1 session

Experimental Tobacco Marketplace (ETM) Session

Participants engage in scenarios within the ETM to assess purchasing behaviors under different conditions

1 session

Follow-up

Participants are contacted for a follow-up phone call to discuss their experiences and any changes in behavior

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Low Nicotine Standard
• Tobacco Prices

Trial Overview The study examines how lowering nicotine in cigarettes, along with the price of illegal cigarettes and e-cigarettes, affects people's buying habits in a simulated market.

How Is the Trial Designed?

Group I: Exclusive cigarette smokers Experimental Treatment 3 Interventions

Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.

Group II: Dual cigarette/ nicotine vaping product users Experimental Treatment 3 Interventions

Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624003168

Associations between compliance with very low nicotine ... Compliance with VLNCs prior to quitting increased abstinence self-efficacy and predicted better quit outcomes above and beyond baseline smoking characteristics.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823300

Reduced Nicotine Cigarettes and E-Cigarettes in High ... This report of 3 randomized clinical trials investigates smoking reduction in adults with psychiatric conditions or lower educational level ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMc1513886

Randomized Trial of Reduced-Nicotine Standards for ... With regard to passive smoking, the intent of nicotine reduction is to prevent the development and maintenance of dependence and in doing so to reduce smoking.

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.884605/full

The Effects of Immediate vs Gradual Reduction in Nicotine ... A number of clinical studies show that smokers who received an immediate reduction in nicotine content to very low levels have significantly greater reductions ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9699899/

Effects of Very Low Nicotine Content Cigarettes on ... Those assigned to VLNC cigarettes had lower CPD, CO levels and craving, and reported lower cigarette satisfaction and reward than those assigned to NNC ...

7. cdc.gov cdc.gov/tobacco/php/data-statistics/youth-data-tobacco/index.html

Youth and Tobacco Use Youth who use multiple tobacco products are at higher risk for developing nicotine dependence and might be more likely to continue using tobacco products into ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524002717

Correcting misperceptions about very low nicotine ... This study explores effective message strategies to inform the public about health risks associated with VLNC use, encourage cigarette smokers to try VLNC,

9. 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 ...