Vaping for Smokers' Cancer Risk

ST
AB
Overseen ByAhmad Besaratinia, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the differences in cancer risk between e-cigarette use and traditional smoking. Researchers will examine changes in oral cells to understand the potential cancer effects of e-cigarette use. Participants include smokers interested in switching to e-cigarettes, those who continue to smoke, and non-smokers who don't vape. Smokers who consume more than five cigarettes daily and want to try e-cigarettes (such as the NIDA Standard Research E-cigarette) or continue smoking might be a good fit for this study. As an unphased study, this trial offers a unique opportunity to contribute to important research on smoking alternatives.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used any medication that affects the CYP450 2A6 enzyme.

What prior data suggests that this protocol is safe for participants?

Research has shown that switching from regular cigarettes to e-cigarettes might not increase cancer risk. One study found no significant cancer risk in individuals who had never smoked regular cigarettes but used e-cigarettes. This finding suggests that e-cigarettes could pose a lower cancer risk than traditional cigarettes.

However, e-cigarettes do expose users to some harmful substances, which can increase the risk of lung diseases and lead to nicotine addiction. Users might become dependent. While e-cigarettes may present a lower cancer risk compared to regular cigarettes, they still pose health concerns.

For those considering joining the trial, it is helpful to know that e-cigarettes have been extensively studied. However, like any new treatment, there are still aspects of their long-term safety to learn.12345

Why are researchers excited about this trial?

Researchers are excited about using the NIDA Standard Research E-cigarette (SREC) for smokers because it offers a potentially less harmful alternative to traditional smoking. Unlike smoking, which involves burning tobacco and inhaling over 7,000 chemicals, vaping with SREC eliminates combustion, thereby reducing exposure to many harmful substances. Additionally, vaping may help ease nicotine cravings without some of the severe health risks associated with smoking, offering a promising option for reducing cancer risk among smokers. This trial could reveal important insights into how switching to vaping impacts long-term health outcomes compared to continued smoking.

What evidence suggests that vaping might be an effective alternative for reducing cancer risk in smokers?

Research has shown that the NIDA Standard Research E-cigarette (SREC), which participants in the "Vapers" arm of this trial will use, might help reduce smokers' cravings. One study found that people who switched to the SREC experienced a much lower urge to smoke after six weeks. Additionally, current evidence suggests that vaping e-cigarettes does not significantly increase the risk of lung or other cancers for those who have never smoked regular cigarettes. These findings indicate that switching from regular cigarettes to e-cigarettes might lower some health risks associated with smoking. However, it is important to note that the long-term effects are still under investigation.23678

Who Is on the Research Team?

AB

Ahmad Besaratinia

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for smokers aged 22-55 who've smoked more than 5 cigarettes daily for over a year and want to switch to vaping, continue smoking, or remain smoke/vape-free. Participants must be able to consent and follow the study without major life disruptions. Those with severe mental illness, substance abuse, extreme body weight, recent pregnancy or drug use, certain medical conditions or treatments are excluded.

Inclusion Criteria

I am between 22 and 55 years old.
I do not plan to move, take long vacations, or have surgery during the study.
Being able to read and write in English and understand and give informed consent
See 3 more

Exclusion Criteria

Being pregnant or having a baby in the past 12 months
Having any known allergy to propylene glycol/vegetable glycerin (applicable participants who will undergo intervention with e-cig (Grp 1) only)
You have a body mass index (BMI) that is either too low or too high.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Collection of baseline oral cell samples and initial assessments

1 week
1 visit (in-person)

Intervention

Participants undergo a 3-month intervention with weekly compliance checks and bi-weekly oral cell sampling

12 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NIDA Standard Research E-cigarette (SREC)
Trial Overview The study compares cancer-related biomarkers in oral cells among three groups: smokers switching to e-cigarettes (Grp 1), regular smokers (Grp 2), and non-smokers/non-vapers (Grp 3). It uses 'multi-omics' analysis on genome changes relevant to cancer risk during the intervention.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: VapersExperimental Treatment1 Intervention
Group II: SmokersActive Control1 Intervention
Group III: Nonsmokers non-vapersActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

University of California

Collaborator

Trials
46
Recruited
208,000+

Citations

Vaping Devices (Electronic Cigarettes) DrugFactsLike the previous study, these results suggest that teens using e-cigarettes are at a greater risk for smoking cigarettes in the future.
The effects of switching to the standardized research ...Participants in the SREC condition reported significantly lower urge to smoke at week 6 compared to those in control, (B = −17.05, 95 % CI = - ...
Evidence update on the cancer risk of vaping e-cigarettesNo significant incident or prevalent risk of lung cancer or other types of cancer was found in the never smoker current vapers population.
Vaping for Smokers' Cancer Risk · Info for ParticipantsThis trial is testing if switching from regular cigarettes to e-cigarettes affects cancer risk. It involves smokers who switch to e-cigs, smokers who ...
Grants | OSUCCC - Ohio State's Comprehensive Cancer CenterThe proposed work will prospectively examine the effect of switching to the NIDA SREC on changes in smoking patterns, dependence, exposures to harmful toxicants ...
Evidence update on the cancer risk of vaping e-cigarettesNo significant incident or prevalent risk of lung cancer or other types of cancer was found in the never smoker current vapers population.
Study Details | NCT04003805 | Biomarkers of Exposure ...This study is focused on characterizing the toxic and carcinogenic potential of the Standardized Research E-cigarette (SREC) developed by the National ...
Risk and safety profile of electronic nicotine delivery systems ...We found high-level evidence that ENDS exposes users to toxic substances; increases the risk of respiratory disease; leads to nicotine dependence; causes ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security