Relighting Cigarettes for Smoking

Overseen By Irina Stepanov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Masonic Cancer Center, University of Minnesota

Disqualifiers: Alcohol abuse, Drug abuse, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 month

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how relighting cigarettes affects the levels of harmful chemicals in smoke and smokers' experiences. Participants will compare smoking a cigarette continuously with relighting it later. The study aims to determine if relighting increases exposure to toxic chemicals. Suitable participants have smoked at least 10 cigarettes a day for a year and relight at least half of their cigarettes. The trial is not suitable for those planning to quit smoking soon.

As an unphased trial, this study offers smokers a chance to contribute to important research on smoking habits and chemical exposure.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on smoking behaviors rather than medication use.

What prior data suggests that relighting cigarettes is safe?

Research shows that relighting cigarettes can harm health. Studies have found that relighting increases the risk of lung cancer and chronic bronchitis. Relighting may release more harmful chemicals than smoking a cigarette continuously.

These findings suggest that relighting poses greater danger than smoking a cigarette without interruption. While the current trial aims to better understand these effects, existing research highlights potential safety concerns for those who frequently relight cigarettes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are intrigued by the idea of relighting cigarettes because it challenges our understanding of smoking patterns and its effects on health. Unlike traditional continuous smoking, relighting could alter exposure to harmful substances since cigarettes burn differently when relit. This trial aims to uncover if relighting could potentially change the risk profile associated with smoking, providing valuable insights into smoking behaviors and their health impacts. By comparing continuous smoking with relight smoking, scientists hope to gather data that could inform future smoking cessation strategies or public health guidelines.

What evidence suggests that relighting cigarettes affects smoke toxicant levels and smoking behavior?

Research has shown that relighting cigarettes increases the harmful chemicals in the smoke. Studies found that relit cigarettes release more toxic substances than those smoked continuously. In this trial, participants will be assigned to either a continuous smoking condition or a relight smoking condition to compare the effects. Approximately 45% of smokers relight their cigarettes, often due to higher nicotine addiction. Some smokers believe relighting helps them smoke less, but it is not necessarily safer. Evidence suggests that relighting leads to more intense exposure to harmful chemicals. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for smokers who have smoked at least 10 cigarettes a day for over a year, regularly relight their cigarettes, and aren't trying to quit soon. They should be medically stable with specific blood pressure and heart rate limits.

Inclusion Criteria

My blood pressure and heart rate are within normal ranges.

Engaging in relighting for at least half of their CPD

Smoking at least 10 cigarettes/day for at least 1 year (confirmed by CO > 8 ppm or NicAlert test of 6)

Exclusion Criteria

Participant with current or recent alcohol or drug abuse problems, use of substances of abuse (other than marijuana due to high prevalence of co-use) within the past month

Currently trying or planning to quit smoking in the next month

Planning to become pregnant, pregnant or breastfeeding. Pregnancy exclusion will be confirmed through a urine test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in smoking sessions with relit and non-relit cigarettes, with measurements taken before and after smoking.

1 month

2 visits (in-person), separated by 7-10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Relighting

Trial Overview The study investigates the effects of relighting cigarettes on smoke toxicant levels and smoker's experiences. It involves comparing toxicants from usual cigarettes when smoked normally versus being relit in both natural settings and clinic measurements.

How Is the Trial Designed?

Group I: Relight Smoking Experimental Treatment 1 Intervention

During the study visits, measures will be taken before and after participants smoke their own usual brand cigarette one continuously. Participants will be randomly assigned to continuous smoking or relight smoking conditions. Participants randomized to the relight smoking condition will crossover to the continuous smoking condition after 60 minutes on their first visit. Visits will be separated by 7-10 days, to ensure there are 2 weekdays and 1 weekend day falling in that period for cigarette butt collection. On the second visit, participants will begin with the second smoking condition they were assigned on their first visit. They will crossover to the remaining condition after 60 minutes. Participants initially assigned to the relighting smoking condition will begin their second visit with the continuous smoking condition and cross over to the relighting smoking condition after the 60 minutes.

Group II: Continuous Smoking Experimental Treatment 1 Intervention

During the study visits, measures will be taken before and after participants smoke their own usual brand cigarette one continuously. Participants will be randomly assigned to continuous smoking or relight smoking conditions. Participants randomized to the continuous smoking condition will crossover to the relight smoking condition after 60 minutes on their first visit. Visits will be separated by 7-10 days, to ensure there are 2 weekdays and 1 weekend day falling in that period for cigarette butt collection. On the second visit, participants will begin with the second smoking condition they were assigned on their first visit. They will crossover to the remaining condition after 60 minutes. Participants initially assigned to the continuous smoking condition will begin their second visit with the relighting smoking condition and cross over to the continuous smoking condition after the 60 minutes.

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Heat-not-burn (HNB) cigarettes produce lower amounts of harmful particulate matter compared to traditional combustion cigarettes, with the order of toxicity being Ploom S < glo < IQOS < hi-lite.

Mainstream smoke from HNB devices showed reduced cytotoxic effects on human vascular endothelial cells compared to smoke from combustion cigarettes, suggesting that HNB products may be less harmful to vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of cytotoxicity of cigarette smoke extract derived from heat-not-burn and combustion cigarettes in human vascular endothelial cells. Horinouchi, T., Miwa, S.[2022]

Dropped cigarettes cause approximately 1,000 deaths and 3,000 serious injuries annually in the U.S., leading to significant economic costs due to property loss and healthcare.

Recent federal studies indicate that it is technically feasible to create fire-safe cigarettes, and they have established a validated testing method to assess the fire-starting potential of different cigarette brands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress towards a fire-safe cigarette. Brigham, PA., McGuire, A.[2005]

A study involving 620 adult smokers in Massachusetts found that the introduction of reduced ignition propensity (RIP) cigarettes did not significantly change self-reported fire-risk behaviors or intentions to quit smoking after 8 months.

Post-implementation, smokers reported smoking fewer than 20 cigarettes per day and were less likely to inhale deeply, suggesting some behavioral adjustments without adverse effects from the new cigarette design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smokers' self-reported responses to the introduction of reduced ignition propensity (RIP) cigarettes. Seidenberg, AB., Rees, VW., Alpert, HR., et al.[2021]

Cigarette-related fires, particularly from upholstered furniture and mattresses, lead to over 1500 deaths and 7000 serious injuries annually in the U.S., highlighting a significant public health issue.

A recent three-year federal study has shown that modifying cigarette designs can significantly reduce their ability to ignite fires, and there is pending legislation to establish a fire safety standard for cigarettes that should be supported by the medical community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fire-safe cigarette. Botkin, JR.[2016]

About 69.4% of the 248 adult smokers studied reported relighting their cigarettes, which was associated with higher nicotine dependence, older age, lower income, and unemployment.

Despite the high prevalence of relighting among smokers, there were no significant differences in exposure to tobacco smoke constituents, as measured by blood cotinine and exhaled carbon monoxide, between relighters and non-relighters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Adult Cigarette Smokers Who "Relight" and the Effects of Exposure to Tobacco Smoke Constituents. Allen, SI., Wasserman, E., Veldheer, S., et al.[2020]

In a study of 496 patients seeking tobacco treatment, 46% reported relighting cigarettes, which was associated with smoking fewer cigarettes per day despite similar dependence levels, indicating a unique smoking behavior that may affect treatment outcomes.

Relighting was more common among specific groups, including females, African-Americans, and those with lower education and employment status, suggesting that economic factors and dependence markers play a significant role in this behavior, which could influence tobacco treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relighting behaviour among cigarette smokers seeking treatment: implications for tobacco treatment and policy. Zimmermann, MH., Richardson, DL., Manderski, MT., et al.[2021]

There is potential to reduce health risks for smokers by developing cigarettes that remove toxic components and lower overall smoke intake, which could lead to a decrease in disease incidence over time.

While these modified cigarettes may not taste the same as traditional ones, changing consumer perceptions and adding compensating flavors could encourage smokers to switch, ultimately aiming to reduce smoking-related health issues significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-risk cigarettes: a prescription. Gori, GB.[2023]

In a study of 434 daily smokers, about half reported relighting cigarettes, which is linked to higher smoking addiction severity and certain demographic factors like being female and having lower socioeconomic status.

Smokers who are considering quitting are less likely to relight cigarettes, highlighting a potential area for public health interventions to reduce harm associated with this practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relighting cigarettes: how common is it? Cunningham, JA., Selby, P.[2015]

Relighting unfinished cigarettes is a common behavior among smokers, with about 45% of smokers engaging in it, particularly those with lower socioeconomic status and higher nicotine dependence.

Despite its prevalence, tobacco treatment providers often overlook relighting in their assessments and treatment plans, highlighting a need for further research to understand its implications for tobacco cessation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarette Relighting: A Series of Pilot Studies Investigating a Common Yet Understudied Smoking Behavior. Heckman, CJ., Wackowski, OA., Mukherjee, R., et al.[2023]

The new cigarette design burns significantly less tobacco and paper, which is expected to reduce harmful tar and combustion products compared to conventional cigarettes.

The ECLIPSE Expert Panel reviewed the potential health hazards of this new cigarette, suggesting it may produce less sidestream smoke and have a safer profile than traditional cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Safer Cigarette? A Comparative Study. A Consensus Report. [2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9278837/

The Impact of Cigarette Relighting on Nicotine ... Of the 31 participants who reported a >=50% reduction in CPD at 3-month follow-up, 5 (16%) did not achieve the outcome of >=50% reduction in the frequency of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0376871624001789

Measurement of cigarette relighting: A common but ... Similarly, 59% reported relighting to make cigarettes last longer. Nearly half (44%) reported relighting to cut down or quit smoking, and 34% do ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ijcp.12477

Relighting behaviour among cigarette smokers seeking ... Results. Forty-six per cent of the sample reported relighting, and those subjects smoked significantly fewer cigarettes per day (CPD), despite ...

4. researchgate.net researchgate.net/publication/352469281_Cigarette_Relighting_A_Series_of_Pilot_Studies_Investigating_a_Common_Yet_Understudied_Smoking_Behavior

Cigarette Relighting: A Series of Pilot Studies Investigating ... Relighting was found to be common (approximately 45% of smokers), and associated with lower socioeconomic status, heavier smoking and nicotine dependence.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06295757

Effects of Relighting on Smoke Toxicant Deliveries and ... Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes. Official Title. Effects of Relighting on Smoke Toxicant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6698945/

Characteristics of Adult Cigarette Smokers Who “Relight” ... The authors suggested that relighting cigarettes significantly contributed to lung cancer risk. This study was conducted during a period of time when most ...

7. cinj.org cinj.org/research-cancer-institute-new-jersey-cigarette-relighting-tied-tough-economy

Cigarette Relighting Tied to Tough Economy “In fact, smokers who relight cigarettes may be at higher risk of lung cancer and chronic bronchitis. That is something of which policy makers need to be aware, ...

8. sph.umn.edu sph.umn.edu/events-calendar/research-day/past-events/rd-2020/alcheva-aleksandra/

Alkaloids and nitrosamines in tobacco filler of half-smoked ... Moreover, relighting cigarettes is associated with increased lung cancer risk and higher rates of chronic bronchitis.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8296510/

Cigarette Relighting: A Series of Pilot Studies Investigating ... In 2016, daily smokers who frequently thought about smoking health risks had a higher prevalence of frequent relighting (23%) than those who ...