Varenicline + Nicotine Patch for Quitting Smoking

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antidepressants, Opioids, Smoking cessation meds

Disqualifiers: Seizure disorder, Severe kidney disease, Cardiovascular disease, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether varenicline (a medication to help quit smoking) or a nicotine patch can assist people in quitting smoking, particularly those with varying emotion and attention levels. Participants will join one of two groups: one using varenicline with a placebo patch and the other using a nicotine patch with a placebo tablet. The trial includes counseling sessions and regular check-ins to support participants in their journey to quit. It suits individuals who have smoked at least five cigarettes a day for the past two months and are interested in changing their smoking habits. As a Phase 4 trial, this research seeks to understand how these FDA-approved treatments can benefit more patients.

Do I need to stop taking my current medications to join the trial?

The trial requires you to stop using certain smoking cessation medications like Wellbutrin, Bupropion, Zyban, NRT, and Chantix at least 7 days before joining. Some depression medications like MAOIs and Elavil (Amitriptyline) must be stopped 14 days prior. Other medications will be evaluated on a case-by-case basis by the study physician.

What is the safety track record for these treatments?

Research has shown that varenicline is generally safe for those trying to quit smoking. It has helped more people quit than a placebo, which is a fake treatment. However, some individuals have reported side effects such as changes in behavior, mood swings, and trouble sleeping. The FDA has also noted rare risks, including interactions with alcohol.

Studies confirm that the nicotine patch is safe and effective. As an over-the-counter product, many people use it to quit smoking. Some users might experience skin irritation where the patch is applied or mild dizziness. Overall, it is considered safer than smoking cigarettes.

Both treatments have been thoroughly studied, and their safety is well-documented. This information may reassure those considering joining the trial about the safety of these treatments. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they combine familiar smoking cessation aids in new ways. Varenicline is a prescription medication that helps reduce cravings and withdrawal symptoms by targeting nicotine receptors in the brain. When used alongside a nicotine patch, which provides a steady, low dose of nicotine to ease withdrawal, the combination might offer a more powerful strategy for quitting smoking than either treatment alone. This dual approach could help smokers set a quit date and stick to it more effectively, offering hope for better success rates compared to standard single-treatment options.

What evidence suggests that this trial's treatments could be effective for quitting smoking?

Studies have shown that varenicline, one of the treatments in this trial, helps people quit smoking. It increases the duration of smoke-free periods, especially when combined with counseling, achieving quit rates of nearly 45% during treatment. Research suggests that using varenicline for up to 24 weeks can further reduce the likelihood of relapse. In this trial, some participants will receive varenicline with a placebo patch.

Nicotine patches, another treatment option in this trial, also aid in quitting smoking. They more than double the chances of quitting compared to a placebo patch by steadily providing nicotine to ease withdrawal symptoms. Participants in this trial may receive a nicotine patch with a placebo tablet. Both treatments have strong evidence supporting their effectiveness in helping people quit smoking. ^{2 6 7 8 9}

Who Is on the Research Team?

Jason D Robinson, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults aged 18-75 who smoke at least 5 cigarettes daily, want to quit smoking, and can follow instructions in English. They must be the only participant from their household and have a reachable address and phone number. Excluded are those using other tobacco products frequently, enrolled in another cessation program, with uncontrolled hypertension or significant recent disease, certain psychiatric conditions or drug use.

Inclusion Criteria

Provide informed consent and agree to all assessments and study procedures

Able to follow verbal and written instructions in English and complete all aspects of the study

Be the only participant in their household

Exclusion Criteria

I plan to use nicotine substitutes or treatments to quit smoking soon.

I have not had a serious or unstable illness in the last 3 months.

History of hypersensitivity or allergic reaction to Varenicline, NRT, or any component of these formulations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-10 days

1 visit (in-person)

Treatment

Participants receive varenicline or nicotine patch for smoking cessation, with counseling and regular assessments

12 weeks

7 visits (4 in-person, 3 phone)

End-of-Treatment

Final assessments including CO level, liver and kidney function tests, and counseling

1 day

1 visit (in-person)

Follow-up

Participants are monitored for smoking abstinence and safety at 3 and 6 months post-treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Counseling Sessions
• Lab Session
• Nicotine Patch
• Placebo Patch
• Placebo Tablet
• Questionnaires
• Saliva Test
• Varenicline

Trial Overview The study is testing whether varenicline (a medication) or nicotine patches help people with varying emotional and attention levels quit smoking. Participants will undergo saliva tests, counseling sessions, lab sessions, questionnaires and receive either the actual treatments or placebo versions.

How Is the Trial Designed?

Group I: Varenicline + Placebo Patch Experimental Treatment 6 Interventions

Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1. Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day. Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape. Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.

Group II: Nicotine Patch + Placebo Tablet Experimental Treatment 6 Interventions

Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening. Starting on Day 8, and then every day after that, participant applies 1 nicotine patch. Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.

Nicotine Patch is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Nicoderm CQ for:

• Smoking cessation

Approved in European Union as Nicotrol for:

• Smoking cessation

Approved in Canada as Nicorette for:

• Smoking cessation

Approved in Japan as Nicoderm CQ for:

• Smoking cessation

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

NAL PHARMA

Collaborator

Trials

1

Recruited

200+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

In a randomized controlled trial, varenicline (Chantix) demonstrated a higher abstinence rate from smoking after one year compared to both bupropion SR (Zyban) and a placebo, indicating its efficacy in treating tobacco dependence.

Despite its effectiveness, varenicline has been associated with serious neuropsychiatric side effects, highlighting the importance of discussing potential risks and benefits with patients considering this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence with Chantix (varenicline). Rankin, KV., Jones, DL.[2015]

A systematic review of 14 randomized controlled trials involving 8216 participants found that varenicline, a smoking cessation drug, is associated with a significantly increased risk of serious cardiovascular events compared to placebo, with an odds ratio of 1.72.

The analysis indicates safety concerns regarding varenicline, as serious cardiovascular events occurred in 1.06% of users compared to 0.82% in the placebo group, suggesting that while varenicline is effective for smoking cessation, it may pose risks to heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. Singh, S., Loke, YK., Spangler, JG., et al.[2022]

Varenicline (Champix) is a newly approved medication for smoking cessation that acts as a partial agonist of nicotinic receptors, offering a different mechanism of action compared to traditional therapies like nicotine replacement and bupropion.

Recent studies indicate that varenicline is effective in helping individuals quit smoking and may have advantages over existing treatments, although potential side effects are also discussed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug of the month. Varenicline (Champix)]. Vandemergel, X.[2015]

In a study of 1027 adult smokers, varenicline was found to be significantly more effective for smoking cessation than both placebo and bupropion SR, with 43.9% of participants abstinent during the last 4 weeks of treatment compared to 17.6% and 29.8% respectively.

Varenicline was generally safe and well-tolerated, with the most common side effect being nausea, affecting 29.4% of participants, and a discontinuation rate due to adverse events similar to that of bupropion SR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. Jorenby, DE., Hays, JT., Rigotti, NA., et al.[2023]

In a study of over 200,000 adults, varenicline (VAR) was found to have lower smoking-attributable and all-cause medical costs compared to nicotine-replacement therapy patches (NRT-P) over a year, suggesting it may be a more cost-effective smoking cessation option.

Among patients who adhered to their treatment, VAR still showed lower annual medical costs despite higher pharmacy costs, indicating that the overall financial burden of smoking cessation may be reduced with VAR compared to NRT-P.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare Costs of Smokers Using Varenicline Versus Nicotine-Replacement Therapy Patch in the United States: Evidence from Real-World Practice. Lee, LJ., Li, Q., Bruno, M., et al.[2020]

Smoking cessation is crucial for health, and psychiatric nurses should actively support patients in using therapies like varenicline (Chantix) to quit smoking.

Recent research has raised safety concerns about varenicline, including its potential links to neuropsychiatric side effects, seizures, and interactions with alcohol, which clinicians need to consider when recommending this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. Tobin, TJ., Tobin, ML.[2018]

In a study involving 1251 adult smokers, combining varenicline with a nicotine patch or extending varenicline treatment from 12 to 24 weeks did not significantly improve smoking cessation rates after 52 weeks.

The primary outcome of 7-day point prevalence abstinence was similar across all treatment groups, indicating that neither combination therapy nor longer treatment duration provided additional benefits for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. Baker, TB., Piper, ME., Smith, SS., et al.[2022]

In a real-world study involving 566 participants across four European countries, varenicline was found to be an effective smoking cessation aid, with a 64.6% quit rate by the end of the 12-week treatment period.

The safety profile of varenicline was acceptable, with the most common side effects being mild to moderate nausea (8.9%) and insomnia (2.9%), and only 3.4% of participants discontinued due to treatment-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. Boudrez, H., Gratziou, C., Messig, M., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8201739/

The effectiveness of the nicotine patch for smoking ... Active patch subjects were more than twice as likely to quit smoking as individuals wearing a placebo patch, and this effect was present at both high and low ...

2. haleonhealthpartner.com haleonhealthpartner.com/en-us/respiratory-health/brands/nicotine-replacement-therapy/nicoderm-cq/nicoderm-cq-efficacy/

NicoDerm CQ Clear Patch Efficacy NicoDerm CQ doubles your patients' chances of quitting vs. placebo. 4 It provides sustained nicotine delivery over 24 hours to your patients.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871600002374

The efficacy of computer-tailored smoking cessation ... As expected, among those who reported they used their assigned materials (80.1% of the sample) smokers who received CQP demonstrated higher quit rates at both 6 ...

4. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-use-a-nicotine-patch.html

How to Use Nicotine Patches | Quit Smoking The nicotine patch is an FDA-approved medicine that can help people quit smoking. It can be used daily by itself to control withdrawal symptoms, or it may be ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4410859/

Long-term Nicotine Replacement Therapy To compare 8 (standard), 24 (extended), and 52 (maintenance) weeks of nicotine patch treatment for promoting tobacco abstinence.

6. mayoclinic.org mayoclinic.org/drugs-supplements/nicotine-transdermal-route/description/drg-20068808

Nicotine (transdermal route) - Side effects & dosage Nicotine skin patches are used to help you stop smoking. Nicotine is absorbed from the patch on the skin and enters the blood stream.

7. goodrx.com goodrx.com/health-topic/nicotine/nicotine-patch-side-effects?srsltid=AfmBOopSfNTQj_YGtLw9uT5tTFGz-qzY3M_ibb9h6RxMkFtTgFKDxv1i

8 Nicotine Patch Side Effects and How to Manage Them These over-the-counter (OTC) products are both safe and effective at helping people quit smoking. Though some people may experience side effects ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/020165Orig1s047lbl.pdf

Nicoderm CQ - accessdata.fda.gov Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to ...

9. nicorette.com nicorette.com/shop/patch/?srsltid=AfmBOoq8FDLudoqRlwnvmIW05XkdGSeAYn8KBd-kbxAwRPO02Oelvtcc

NicoDerm CQ Nicotine Patches: Relief You Can Wear Buy NicoDerm CQ patches from Nicorette to help you quit smoking. You can wear these nicotine patches under your clothes to ease your cravings discreetly.