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
Trial Overview
The study tests different strategies to quit smoking using two main treatments: Combination Nicotine Replacement (C-NRT) and varenicline. It looks at medication type, preparation time before quitting, treatment duration, and counseling intensity in various combinations over a year.
How Is the Trial Designed?
16
Treatment groups
Active Control
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Published Research Related to This Trial
Citations
Combination Pharmacotherapy for Stopping Smoking
Significantly higher smoking abstinence rates were observed with the nicotine patch + inhaler at 6 and 12 weeks compared to the inhaler alone. Combination ...
Varenicline and Nicotine Replacement Therapy for ...
If used in combination with nicotine replacement therapy (NRT), cessation rates may be further improved, but the efficacy and safety of the ...
Nicotine replacement therapy as a smoking cessation tool ...
Results: NRT demonstrated limited success in long-term smoking cessation among adolescents, with low cessation rates that often declined post- ...
Systematic review and meta-analysis of combination ...
Current literature indicates that combination therapy is statistically better than monotherapy in smoking cessation treatment as assessed by 3-, 6-, and 12- ...
Effectiveness of Nicotine Replacement Therapy and ...
This study portrays the effectiveness of combining behavioral intervention (BI) with nicotine replacement therapy (NRT) in promoting cessation of tobacco use in ...
Combination nicotine replacement therapy (NRT)
9,10. The SNAP study found the NRT patch doubled four-week quit rates and did not result in adverse pregnancy outcomes or children at two-year follow-up.10 ...
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.
8.
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.
Combination nicotine replacement therapy: strategies for ...
Combination NRT is a safe and effective aid for smoking cessation, but under-utilized due to lack of guidance for initiation and titration.
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