Varenicline + Nicotine Patch for Quitting Smoking

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: M.D. Anderson Cancer Center

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

204 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.

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 data supports the effectiveness of the drug varenicline combined with a nicotine patch for quitting smoking?

Research shows that varenicline, when used alone, is more effective than other treatments like bupropion and placebo for quitting smoking. Combining varenicline with a nicotine patch may further increase its effectiveness in helping people stop smoking. ^{1 2 3 4 5}

Is the combination of varenicline and nicotine patch safe for quitting smoking?

Varenicline, used for quitting smoking, has been shown to be generally safe in studies, but there are concerns about possible side effects like mood changes, seizures, and heart problems. It's important to discuss these risks with a healthcare provider before starting treatment. ^{1 2 4 6 7}

How is the drug combination of varenicline and nicotine patch unique for quitting smoking?

The combination of varenicline and a nicotine patch is unique because varenicline works by reducing withdrawal symptoms and blocking the rewarding effects of nicotine, while the nicotine patch provides a steady, controlled release of nicotine to ease cravings. This dual approach targets both the physical and psychological aspects of nicotine addiction, potentially increasing the chances of successfully quitting smoking. ^{1 2 4 8 9}

Research Team

Paul Cinciripini

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence with Chantix (varenicline). [2015]

2. Belgium pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. [2015]

5. United States 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Canada pubmed.ncbi.nlm.nih.gov

Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. [2022]

8. New Zealand 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. [2021]

9. United States 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. [2023]