Smoking Cessation Medications for Smoking Addiction

No longer recruiting at 1 trial location
ME
SS
Overseen ByStevens Smith, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

ME

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

If currently using nicotine replacement therapy (NRT), agreeing to use only study medication for the duration of the study
I am using birth control as a woman who can still have children.
You have been smoking at least 4 cigarettes every day for the past 6 months.
See 1 more

Exclusion Criteria

You have had thoughts of harming yourself or attempted to harm yourself in the past.
I am currently taking bupropion or varenicline.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants receive preparation medication and counseling prior to the target quit day (TQD)

4 weeks
1 phone or video counseling session

Treatment

Participants receive either Varenicline or C-NRT with counseling, starting on the target quit day (TQD)

12-24 weeks
Multiple phone or video counseling sessions

Follow-up

Participants are monitored for smoking status, treatment use, and side effects

52 weeks
Assessments at Weeks 2, 4, 12, 20, 26, and 52 post-TQD

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?
16Treatment groups
Active Control
Group I: 24-week Varenicline with 4-Week Preparation Varenicline and Minimal CounselingActive Control2 Interventions
Group II: 12-week Varenicline with 4-Week Preparation Varenicline and Intensive CounselingActive Control2 Interventions
Group III: 24-week Varenicline with 4-Week Preparation Varenicline and Intensive CounselingActive Control2 Interventions
Group IV: 12-week C-NRT with Minimal CounselingActive Control2 Interventions
Group V: 24-week C-NRT with Intensive CounselingActive Control2 Interventions
Group VI: 12-week Varenicline with Intensive CounselingActive Control2 Interventions
Group VII: 12-week C-NRT with 4-Week Preparation C-NRT and Minimal CounselingActive Control2 Interventions
Group VIII: 12-week C-NRT with 4-Week Preparation C-NRT and Intensive CounselingActive Control2 Interventions
Group IX: 24-week C-NRT with 4-Week Preparation C-NRT and Intensive CounselingActive Control2 Interventions
Group X: 12-week C-NRT with Intensive CounselingActive Control2 Interventions
Group XI: 24-week Varenicline with Minimal CounselingActive Control2 Interventions
Group XII: 24-week C-NRT with 4-Week Preparation C-NRT and Minimal CounselingActive Control2 Interventions
Group XIII: 24-week C-NRT with Minimal CounselingActive Control2 Interventions
Group XIV: 12-week Varenicline with Minimal CounselingActive Control2 Interventions
Group XV: 12-week Varenicline with 4-Week Preparation Varenicline and Minimal CounselingActive Control2 Interventions
Group XVI: 24-week Varenicline with Intensive CounselingActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 2,682 patients using varenicline for smoking cessation, nausea and vomiting were the most common reasons for discontinuation and the most frequently reported adverse drug reactions, highlighting the need for patient monitoring regarding gastrointestinal side effects.
While some psychiatric events were reported, including anxiety and depression, all cases of suicidal behavior involved patients with prior psychiatric conditions, suggesting that clinicians should closely monitor individuals with such histories when prescribing varenicline.
Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study.Kasliwal, R., Wilton, LV., Shakir, SA.[2021]
In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.
While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.
Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England.Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]
Varenicline, a medication used to help people quit smoking, is known to have some psychiatric and behavioral side effects, including reports of tardive dyskinesia, although these were not previously documented in literature.
This study presents the first two documented cases of withdrawal emergent dyskinesias associated with varenicline, highlighting a potential safety concern for users of the medication.
Withdrawal-Emergent Dyskinesias following Varenicline Therapy.Toffey, BA., Rabin, M., Kurlan, R.[2020]

Citations

Combination Pharmacotherapy for Stopping SmokingSignificantly 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 BookshelfNRTs are designed to replicate the nicotine response typically experienced through smoking, thereby helping individuals manage cravings and withdrawal symptoms.
Adverse 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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