Very Low Nicotine Cigarettes + E-Cigarettes for Smoking Cessation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how low-nicotine cigarettes and e-cigarettes with varying nicotine levels affect smoking behavior, cravings, and mood. Participants will first use their regular cigarettes, then switch to very low nicotine cigarettes, and finally try two types of e-cigarettes with different nicotine levels. The goal is to determine if these changes can help people reduce or quit smoking. The trial seeks daily or occasional smokers interested in trying new nicotine products, who are willing to follow study procedures and avoid using other e-cigarettes or smoking cessation aids during the trial.
As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could lead to new smoking cessation methods.
Will I have to stop taking my current medications?
You may need to stop taking certain medications to join this trial. If you're using smoking cessation meds or certain depression medications, you must stop them for a specific period before joining. It's best to discuss your current medications with the study team to see if they affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cigarettes with very low nicotine content (VLNC) can help smokers achieve better results. Users of these cigarettes often smoke fewer each day, experience less craving, and find smoking less satisfying. This suggests that VLNC cigarettes might be easy to use in the short term.
Regarding electronic cigarettes (e-cigarettes), studies indicate they are generally less harmful than regular cigarettes in the short term. Although they contain nicotine, which is addictive, they are considered safer than traditional cigarettes. However, the long-term safety of e-cigarettes remains unknown.
For those considering joining a trial with these options, evidence suggests that both VLNC cigarettes and e-cigarettes are generally well-tolerated. However, e-cigarettes are not approved by the FDA as a tool to quit smoking. Consulting a healthcare professional before deciding is always advisable.12345Why are researchers excited about this trial?
Researchers are excited about using very low nicotine content cigarettes (VLNCC) and e-cigarettes (ECIG) for smoking cessation because they offer a unique approach compared to traditional nicotine replacement therapies like patches or gum. Unlike standard treatments, which provide steady nicotine levels to reduce withdrawal, VLNCCs drastically reduce nicotine intake by using cigarettes with minimal nicotine. This can help break the addiction cycle by reducing dependency on nicotine itself. Meanwhile, e-cigarettes provide a familiar smoking experience while allowing for gradual nicotine reduction, potentially easing the transition away from traditional cigarettes more comfortably. This dual approach aims to tackle both the physical and behavioral aspects of smoking addiction, which could lead to more effective quitting strategies.
What evidence suggests that this trial's treatments could be effective for smoking cessation?
Research has shown that switching to Very Low Nicotine Content (VLNC) cigarettes, one of the treatments in this trial, can reduce nicotine addiction and exposure to harmful chemicals. Studies have found that VLNC cigarettes lessen cravings and withdrawal symptoms. This method can also decrease the number of regular cigarettes smoked, potentially aiding in quitting smoking over time.
Regarding e-cigarettes, another treatment option in this trial, the evidence is mixed. Some studies suggest that e-cigarettes can help people quit smoking when combined with counseling. Other research has shown that short-term use of e-cigarettes may lead to higher quitting rates compared to not using them at all. However, some data indicate that e-cigarettes do not always improve quitting success. Overall, this trial will explore whether combining these options might offer a promising way for those looking to cut down or quit smoking.56789Who Is on the Research Team?
Paul Cinciripini
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for daily and intermittent cigarette smokers who are interested in trying novel nicotine products. Participants must be able to follow instructions in English, have only one person per household join, and can receive mail and do telehealth visits. They cannot use other e-cigarettes or smoking cessation meds recently, have severe respiratory issues, unstable medical conditions, certain mental health diagnoses, or be pregnant/breastfeeding without birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I
Participants smoke their usual cigarettes brand
Phase II
Participants smoke VLNCC cigarettes provided
Phase III-IV
Participants are randomized to smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks, or vice versa
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Electronic Cigarette
- Nicotine Replacement
- Very Low Nicotine Content Cigarette
Trial Overview
The study tests the effects of greatly reduced nicotine levels in cigarettes versus electronic cigarettes with varying nicotine content on smoker behavior. It aims to see how these changes affect withdrawal symptoms, cravings for nicotine, mood swings, and overall smoking habits among current smokers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks.
PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
E-cigarettes and smoking cessation in real-world ...
As currently being used, e-cigarettes are associated with significantly less quitting among smokers. According to the results of our systematic review and meta- ...
Electronic Nicotine-Delivery Systems for Smoking Cessation
Outcomes. The primary outcome was continuous abstinence from tobacco smoking at 6 months as measured by participant report of no cigarette ...
Effectiveness of e-cigarettes as aids for smoking cessation
On average, using e-cigarettes for cessation in 2017 did not improve successful quitting or prevent relapse.
The Effect of 12-Week e-Cigarette Use on Smoking ...
Our results showed that even short-term use of e-cigarettes leads to greater smoking cessation at 52 weeks compared to counseling alone. e-Cigarettes are a ...
Electronic Cigarettes As a Smoking-Cessation Tool
More than two thirds of respondents (66.8%) reported having reduced the number of tobacco cigarettes they smoked per day after trying e-cigarettes, and nearly ...
Health Effects of Vaping | Smoking and Tobacco Use
Vaping is not safe, with nicotine being addictive and harmful, especially for youth and pregnant women. E-cigarette aerosol contains cancer- ...
Safety and Efficacy of Electronic Cigarettes: A Review - PMC
Currently, ECs appear to be as safe as other forms of NRTs and considerably less toxic than cigarette smoking in the short-term. Their long-term safety, however ...
Tobacco: E-cigarettes
What role do ENDS play in smoking cessation? E-cigarettes as consumer products have not been proven to be effective for cessation at the population level.
Health Risks of E-Cigarettes and Vaping
The Food and Drug Administration has not found any e-cigarette to be safe and effective in helping people who use tobacco products to quit.
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