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

Trial Summary

What is the purpose of this trial?

Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.

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.

Is relighting cigarettes for smoking safe for humans?

There is no specific safety data on relighting cigarettes for smoking, but research on fire-safe and low-risk cigarettes suggests that changes in cigarette design can reduce some hazards, like fire risk and harmful smoke components. However, these changes do not make smoking safe, and the risks of smoking-related diseases remain significant. ^{1 2 3 4 5}

How does the treatment of relighting cigarettes differ from other smoking treatments?

Relighting cigarettes involves extinguishing and later relighting unfinished cigarettes, a behavior that may increase harm compared to other smoking treatments. This practice is unique as it is associated with higher smoking addiction severity and is influenced by socioeconomic factors, unlike standard treatments that focus on reducing or quitting smoking altogether. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Progress towards a fire-safe cigarette. [2005]

2. United States pubmed.ncbi.nlm.nih.gov

Low-risk cigarettes: a prescription. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Smokers' self-reported responses to the introduction of reduced ignition propensity (RIP) cigarettes. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The fire-safe cigarette. [2016]

5. England pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Relighting cigarettes: how common is it? [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cigarette Relighting: A Series of Pilot Studies Investigating a Common Yet Understudied Smoking Behavior. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Characteristics of Adult Cigarette Smokers Who "Relight" and the Effects of Exposure to Tobacco Smoke Constituents. [2020]

9. India pubmed.ncbi.nlm.nih.gov

Relighting behaviour among cigarette smokers seeking treatment: implications for tobacco treatment and policy. [2021]

10. Japan 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. [2022]