Smoking Cessation Medications for Quitting Smoking
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of certain smoking cessation aids, such as varenicline (a prescription medication) or nicotine patches and lozenges, when provided remotely as free samples. The goal is to determine how these treatments assist daily smokers interested in quitting. Participants will be randomly assigned to receive a sample of varenicline, nicotine products, or neither. Participation involves completing surveys and daily diaries for a short period. To qualify, participants must be daily smokers who have smoked for over a year and have some interest in quitting. As a Phase 1, Phase 2 trial, this research aims to understand how the treatments work in people and measure their effectiveness in an initial, smaller group.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be taking any medications to help quit smoking.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that varenicline, a medication to help people stop smoking, is generally well-tolerated but can have some side effects. In clinical trials, about 28% of users experienced nausea, and 15.5% had headaches. These side effects occurred more frequently than in those taking a placebo (a pill with no active ingredients). Despite these side effects, varenicline significantly increased the chances of quitting smoking.
Nicotine Replacement Therapy (NRT), such as patches and lozenges, is also commonly used to help people quit smoking. NRTs provide a small amount of nicotine to help manage cravings and withdrawal symptoms. Many studies have shown that NRT is safe and can nearly double the chances of quitting smoking. Side effects are usually mild and may include skin irritation from patches or mouth irritation from lozenges.
Both varenicline and NRT have FDA approval, indicating they are considered safe for helping people quit smoking.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for smoking cessation because they offer unique approaches compared to traditional methods. Varenicline, typically used at higher doses, is being tested at a lower dose of 0.5 mg, which has shown effectiveness with potentially fewer side effects. This gives smokers a new option that may be easier on their system. Nicotine Replacement Therapy (NRT), while a standard treatment, is being explored with flexible dosing, allowing participants to adjust their usage based on their smoking habits, which could lead to more personalized and effective cessation strategies. Both approaches aim to provide smokers with more tailored and potentially less disruptive ways to quit smoking.
What evidence suggests that this trial's treatments could be effective for quitting smoking?
In this trial, participants will be randomized to receive either Varenicline, Nicotine Replacement Therapy (NRT), or be part of a control group. Research has shown that Varenicline effectively helps people quit smoking. Specifically, studies indicate that using Varenicline for 12 to 24 weeks significantly increases the chances of quitting compared to not using it. It also outperforms other methods like nicotine patches or gums.
NRT, which includes patches and lozenges, is another treatment option in this trial. It helps people quit smoking by managing cravings and withdrawal symptoms through a small, controlled amount of nicotine without the harmful effects of tobacco smoke. Using NRT can more than double the chances of successfully quitting smoking. Both treatments have proven effective in helping people quit smoking.16789Are You a Good Fit for This Trial?
The STARS study is for adult smokers who have smoked more than a year, smoke at least 5 cigarettes daily, and are somewhat interested in quitting. They must have seen their primary care doctor within the past year, not be pregnant or breastfeeding, and should not have a history of seizures or severe mental health issues like schizophrenia.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 4-week sample of varenicline or nicotine replacement therapy, or no intervention
Follow-up
Participants are monitored for smoking cessation outcomes and medication use
What Are the Treatments Tested in This Trial?
Interventions
- Nicotine Replacement Therapy (NRT)
- Varenicline 0.5 MG
Trial Overview
This trial tests if one-time samples of smoking cessation medications (varenicline or nicotine patches/lozenges) sent remotely can help smokers quit. Participants will randomly receive varenicline, nicotine products, or no treatment. The study involves surveys over six months and daily diaries for the first month.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience.
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish.
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Citations
Nicotine Replacement Therapy - StatPearls - NCBI Bookshelf
NRTs are designed to replicate the nicotine response typically experienced through smoking, thereby helping individuals manage cravings and withdrawal symptoms.
Nicotine Replacement Therapy: An Overview - PMC
Nicotine replacement therapy (NRT) aims to reduce motivation to consume tobacco and the physiological and psychomotor withdrawal symptoms through delivery of ...
3.
mayoclinic.org
mayoclinic.org/diseases-conditions/nicotine-dependence/in-depth/quit-smoking-products/art-20045599Quit-smoking products: Boost your chance of success
Using quit-smoking products can greatly boost your chance of success. They may more than double your odds of quitting smoked tobacco.
Study Details | NCT06832098 | Nicotine Patch Plus ...
Outcome data: The primary outcome is being vape-free and tobacco-free, defined as self-reported continuous abstinence from vaping at six-months post-end ...
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 ...
6.
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. It hasn't been studied as much for quitting smokeless ...
Want to Quit Smoking? FDA-Approved Cessation Products ...
Smoking cessation products approved or cleared by the FDA are shown to help people quit smoking and can even double your chance of quitting ...
How to Use Nicotine Lozenges | Quit Smoking
All have been shown to be safe and effective for adults who smoke cigarettes. These quit-smoking medicines include nicotine replacement medicines (the nicotine ...
9.
tobaccoinduceddiseases.org
tobaccoinduceddiseases.org/Adverse-events-associated-with-nicotine-replacement-therapy-NRT-for-smoking-cessation,65973,0,2.htmlAdverse events associated with nicotine replacement ...
Nicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence.
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