1500 Participants Needed

Vaping vs. Nicotine Replacement for Smoking Behavior

TO
Overseen ByThe Ohio State Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different tools can aid smoking cessation, focusing on electronic cigarettes (ECs) compared to nicotine patches and lozenges. Researchers aim to determine if the flavor of ECs, such as tobacco or non-tobacco, influences their appeal and effectiveness in reducing smoking cravings and withdrawal symptoms. Participants will be divided into three groups to use preferred flavor ECs, tobacco flavor ECs, or nicotine replacement therapy (NRT), which includes options like nicotine gum, lozenges, patches, inhalers, and mouth spray, for 14 weeks. This study suits individuals who smoke at least 5 cigarettes a day, are open to trying either ECs or NRT, and possess a smartphone. As an unphased trial, it offers a unique opportunity to explore personalized smoking cessation options.

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 are currently using smoking cessation medications or nicotine replacement therapy.

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

A previous study showed that vaping can help people quit smoking with fewer serious side effects than regular cigarettes. Research indicates that the risk of death or major health problems from vaping is low. However, vaping carries some risks, such as nicotine addiction, lung irritation, and other health issues, though these are usually less severe than those from smoking.

For nicotine replacement therapy (NRT), such as patches and lozenges, safety has been well-proven. The FDA has approved NRT to help people quit smoking, and it is known to be safe for most users.

Both vaping and NRT are considered safer than smoking, but each has its own risks. It's important to consider these when deciding to join a clinical trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it compares vaping with nicotine replacement therapy (NRT) in helping people quit smoking. Unlike traditional methods like nicotine patches and lozenges, vaping in this context might offer a different psychological and behavioral experience that could make quitting easier for some. The trial also includes a unique educational component, where participants engage in discussions, potentially boosting success rates by addressing the social and habitual aspects of smoking. By exploring these different approaches, researchers aim to understand which method is more effective, offering new insights into smoking cessation strategies.

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

This trial will compare the effectiveness of e-cigarettes and nicotine replacement therapy (NRT) in helping people quit smoking. Studies have shown that e-cigarettes can help people quit smoking more effectively than nicotine patches or gum, especially when combined with support from a counselor or support group. Research indicates that e-cigarettes, whether flavored like tobacco or not, can help reduce the urge to smoke and ease withdrawal symptoms. They also seem to boost motivation and confidence to quit smoking. While some studies suggest e-cigarettes might not work for everyone, they generally seem to be a helpful tool for many smokers. Overall, e-cigarettes show promise as a way to help people stop smoking, with flavored options possibly making them more appealing and effective. Participants in this trial will receive either e-cigarettes or NRT in different arms to evaluate their effectiveness.14678

Who Is on the Research Team?

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Theodore L. Wagener, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for current cigarette smokers who are interested in trying electronic cigarettes (ECs) or nicotine replacement therapy to reduce smoking. Specific eligibility criteria details were not provided, so it's unclear who exactly can or cannot participate.

Inclusion Criteria

Smoke >= 5 cigarettes per day for the past year
Have a smartphone
I am 21 years old or older.
See 1 more

Exclusion Criteria

Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
Current use of an EC > 4 days a month
Known allergy to propylene glycol or vegetable glycerin
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PEC, TEC, or NRT for 14 weeks, including a 2-week pre-switch period to become familiar with usage

14 weeks
Regular discussions throughout the trial

Surveillance

Participants in all arms are followed for 12 weeks after completion of study procedures to monitor smoking behavior and product use

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotine Replacement
Trial Overview The study compares the impact of tobacco-flavored ECs versus non-tobacco flavored ECs and traditional nicotine replacements on smoking habits. It aims to see if different flavors affect the appeal and usage of ECs, as well as their effectiveness in reducing cigarette cravings and dependence.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (TEC)Experimental Treatment2 Interventions
Group II: Arm I (PEC)Experimental Treatment2 Interventions
Group III: Arm III (NRT)Active Control2 Interventions

Nicotine Replacement is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Nicotine Replacement Therapy for:
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Approved in European Union as Nicotine Replacement Therapy for:
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Approved in Canada as Nicotine Replacement Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

In a study of 642 smokers, transdermal nicotine showed a trend towards higher quit rates compared to nicotine lozenges, with 24.3% quitting at the end of treatment versus 18.7% for lozenges.
Smokers who preferred transdermal nicotine and did not use nicotine to manage emotional distress had better success rates, suggesting that individual preferences and reasons for smoking can influence treatment outcomes.
Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program.Schnoll, RA., Martinez, E., Tatum, KL., et al.[2022]
A meta-analysis of 53 randomized controlled trials involving 17,703 subjects found that nicotine-replacement therapy (NRT) significantly increases the odds of smoking abstinence, with an overall odds ratio of 1.71 compared to control groups.
Different forms of NRT showed varying effectiveness, with inhaled nicotine being the most effective (odds ratio of 3.05), while the effectiveness was largely independent of the level of nicotine dependence and the intensity of additional support provided.
Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation.Silagy, C., Mant, D., Fowler, G., et al.[2019]
In a study of 33,690 smokers using nicotine replacement therapy (NRT) through the New York State Smokers' Quitline, about 25% reported adverse effects at 2 weeks, which increased to 42% at 3 months, but most effects were mild.
Only a small percentage (4.4%-5.4%) discontinued NRT due to these adverse effects, indicating that NRT is generally safe for users when proper screening is conducted.
Adverse effects with use of nicotine replacement therapy among quitline clients.Ossip, DJ., Abrams, SM., Mahoney, MC., et al.[2015]

Citations

Electronic cigarette use: comparing smokers, vapers, and ...This study examined vaping behaviour, precursors of vaping, and motivational differences between smokers, dual users and vapers.
Modeling the Effects of E-Cigarettes on Smoking BehaviorResults. If e-cigarettes increase individual-level smoking cessation probabilities by 20%, the model estimates a 6% reduction in smoking prevalence by 2060 ...
E-cigarettes and smoking cessation in real-world ...Odds of quitting cigarettes were 28% lower in those who used e-cigarettes compared with those who did not use e-cigarettes (odds ratio 0·72, 95% CI 0·57–0·91).
Designing an intervention to help the quitters quitOur study suggests when e-cigarettes are used for cessation additional support measures may be needed to achieve “smokers should switch to vaping and vapers ...
Is vaping less harmful than smoking, and does it help ...However, based on the research, vaping does appear to be an effective tool that helps people quit cigarettes. What motivated me to write this ...
Vaping cessation interventions: a systematic review and ...While long-term risks remain unclear, known dangers include nicotine addiction, E-cigarette or Vaping Use-Associated Lung Injury and potential ...
Electronic cigarettes and health outcomes: epidemiological ...Use of nicotine e-cigarettes increases the risks of addiction, poisoning, toxicity from inhalation (including seizures) and trauma and burns.
Socioeconomic disparities in smoking outcomesE-cigarette use and perception of non-harmfulness have increased among youth, with 25% of high school students reporting past 30-day e-cigarette ...
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