Nicotine Replacement Therapy for Smoking and Vaping
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different methods to help people quit both traditional cigarettes and e-cigarettes. Participants will try one of three approaches: behavioral support only, standard nicotine replacement therapy (NRT), or a higher dose of NRT. The study aims to determine which method most effectively helps people stop smoking. It suits adults who smoke cigarettes daily, frequently use e-cigarettes, and are motivated to quit both products soon. Participants must also be willing to try nicotine patches or lozenges and have internet access.
As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that nicotine replacement therapy (NRT) is safe for helping people quit tobacco. NRT includes products like nicotine patches and lozenges. Research indicates that most people tolerate these well, with only mild to moderate side effects reported by some users. Serious side effects are very rare.
Importantly, using NRT can nearly double the chances of quitting smoking successfully. Even when combining the patch and lozenges, studies have found this approach safe for most people. However, it is not recommended for those with certain health issues. Always consult a healthcare provider to determine if NRT is appropriate.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for smoking and vaping cessation because they explore different dosages of Nicotine Replacement Therapy (NRT). While standard treatments like nicotine patches or lozenges are common, this trial tests not only the usual doses but also a higher dose of NRT, which could offer better support for those with intense cravings. The study also includes behavioral support, which is a crucial component not always emphasized in traditional treatments. By combining these approaches, researchers hope to discover a more effective strategy to help people quit smoking and vaping.
What evidence suggests that this trial's treatments could be effective for smoking and vaping cessation?
Studies have shown that nicotine replacement therapy (NRT) can increase the chances of quitting smoking by 50% to 70%. In this trial, participants may receive either a standard or higher dose of NRT, with options like a patch or a lozenge. Combining NRT methods, such as using both a patch and a lozenge, generally proves more effective than using a single type. Research indicates that NRT is beneficial with or without additional counseling. However, while NRT aids many in quitting smoking, its success varies for each individual. Overall, NRT remains a well-supported option for those aiming to quit smoking and vaping.678910
Are You a Good Fit for This Trial?
This trial is for adults who currently smoke cigarettes and use e-cigarettes (dual users) and are motivated to quit both. Participants must be willing to try quitting with support, but specific age or health exclusions aren't listed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of three 12-week interventions: no pharmacotherapy, standard-dose NRT, or augmented-dose NRT, along with behavioral support
Follow-up
Participants are monitored for dual abstinence and cigarette abstinence at 12 and 24 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Nicotine Replacement Therapy (NRT) - Nicotine Lozenge
- Nicotine Replacement Therapy (NRT) - Nicotine Patch
- Text- and web-based support
Trial Overview
The study compares three approaches: no medication (behavioral support only), standard-dose nicotine replacement therapy (nicotine patch plus lozenges), and higher-dose combination NRT. All groups get online/text-based behavioral support over 12 weeks.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will receive a standard dose of nicotine replacement therapy (NRT).
Participants will receive a higher dose of NRT than what is typically used.
Participants will receive behavioral support only.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
Nicotine replacement therapy versus control for smoking ...
The chances of stopping smoking were increased by 50% to 60%. NRT works with or without additional counselling, and does not need to be prescribed by a doctor.
2.
tobaccopreventioncessation.com
tobaccopreventioncessation.com/The-effectiveness-of-nicotine-replacement-therapy-on-oral-smokeless-tobacco-cessation,208023,0,2.htmlThe effectiveness of nicotine replacement therapy on oral ...
Several studies have been conducted to test the effectiveness of NRTs, with mixed results. A previous systematic review found that nicotine ...
Nicotine replacement therapy as a smoking cessation tool ...
NRT demonstrated limited success in long-term smoking cessation among adolescents, with low cessation rates that often declined post-treatment.
Effectiveness of Nicotine Replacement Therapy and ...
At 26 weeks, 63.3% (19/30) in the BI + patch and 52.9% (18/34) in the BI + gum achieved abstinence, compared to 24.1% (7/29) in the BI group.
Nicotine replacement therapy for smoking cessation (Review)
NRTs increase the rate of quitting by 50-70%, regardless of setting. The effectiveness of NRT appears to be largely independent of the intensity of additional ...
Nicotine Replacement Therapy: An Overview - PMC - NIH
large pragmatic randomized trial concluded that using NRT two weeks before the target quit day was safe and well tolerated but offered no benefit over usual
Nicotine Replacement Therapy and Adolescent Patients
NRT is safe and effective in helping adults quit tobacco use, according to the CDC. NRT works best when paired with behavioral counseling ...
Using Nicotine Replacement Therapy
Some smokers have mild to moderate side effects. However, research shows that NRT is safe and effective. NRT can be an important part of almost every smoker's ...
Smoking Cessation: Overview of Nicotine Replacement ...
Major adverse effects from using nicotine gum or the nicotine patch are very rare. Despite the popular belief that smoking while on the patch can be dangerous, ...
10.
cancer.org
cancer.org/cancer/risk-prevention/tobacco/guide-quitting-smoking/nicotine-replacement-therapy.htmlNicotine Replacement Therapy to Help You Quit Tobacco
Many studies have shown using NRT can almost double the chances of quitting smoking. not be safe for adults with certain other health problems.
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