Smoking Cessation Medications for Smoking Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks the best method to help people quit smoking by testing two popular medications: Combination Nicotine Replacement Therapy (C-NRT) and varenicline, which reduces cravings and withdrawal symptoms. It examines different treatment setups, such as the duration of medication use and the amount of counseling provided. The trial targets individuals who have smoked more than four cigarettes daily for the past six months and can refrain from using any nicotine replacement products not supplied by the study. The goal is to determine which combination helps the most people remain smoke-free for a year. Researchers will assess participants' progress through various evaluations, including one that confirms smoking cessation for 12 months. As a Phase 4 trial, this research involves FDA-approved treatments and aims to understand how they can benefit more patients.
Will I have to stop taking my current medications?
If you are currently using nicotine replacement therapy (NRT), you will need to switch to the study medication for the duration of the trial. If you are taking bupropion or varenicline, you cannot participate in the trial.
What is the safety track record for these treatments?
Research has shown that both Combination Nicotine Replacement Therapy (C-NRT) and varenicline have been studied for safety in helping people quit smoking. Studies on C-NRT indicate it is generally well-tolerated, with no major side effects reported. It effectively doubles quit rates and has not shown negative effects on pregnancy or child development in two-year follow-ups.
Extensive research has been conducted on varenicline, which is often prescribed to help people stop smoking. While effective, some individuals may experience side effects like nausea and sleep problems, which can lead them to discontinue use. However, the FDA has approved it for quitting smoking, supporting its safety for most users.
In summary, both treatments are considered safe for most people, but varenicline might cause side effects in some individuals. It's important to consult a healthcare provider about any concerns before starting treatment.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for smoking cessation because they combine pharmacological and behavioral support in a comprehensive approach. The study investigates the use of Varenicline and Combination Nicotine Replacement Therapy (C-NRT), which are already established methods for quitting smoking, but the trial explores different durations and intensities of counseling. Unlike traditional methods that may rely on minimal counseling or set durations, this trial tests varied counseling intensities and medication durations, potentially offering tailored solutions that could enhance success rates. By integrating intensive counseling sessions and extending treatment periods, these approaches aim to provide more robust support, increasing the chances of quitting smoking successfully.
What evidence suggests that this trial's treatments could be effective for smoking addiction?
Research has shown that both varenicline and combination nicotine replacement therapy (C-NRT) effectively aid smoking cessation. In this trial, participants may receive varenicline, which studies have found helps 44% of people stop smoking after 12 weeks, significantly increasing their chances of quitting. Varenicline is more effective than other methods in helping people quit smoking. Alternatively, participants may receive C-NRT, which combines nicotine patches and mini-lozenges. This combination outperforms using a single type of nicotine replacement, leading to higher success rates in quitting smoking at intervals of 3, 6, and 12 months. Both treatments are well-regarded in the medical field for their effectiveness in helping people stop smoking.26789
Who Is on the Research Team?
Megan E Piper, PhD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
This trial is for daily smokers who've been smoking more than 4 cigarettes a day for the past 6 months, can use study medications safely, and if female and able to have children, must be using birth control. Smokers already on bupropion or varenicline or with recent suicidal thoughts or attempts cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Participants receive preparation medication and counseling prior to the target quit day (TQD)
Treatment
Participants receive either Varenicline or C-NRT with counseling, starting on the target quit day (TQD)
Follow-up
Participants are monitored for smoking status, treatment use, and side effects
What Are the Treatments Tested in This Trial?
Interventions
- Combination Nicotine Replacement Therapy
- Intensive Counseling
- Minimal Counseling
- Varenicline
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
National Cancer Institute (NCI)
Collaborator