Smoking Cessation + Pain Management Program for Cancer Survivors

Overseen By Sarah V Hantzmon, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Disqualifiers: Hearing impaired, Unstable mental health, 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: 3

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed pilot study will develop and test feasibility, acceptability, and signal for efficacy of a smoking cessation and pain management intervention for 20 cancer survivors.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Smoking Cessation + Pain Management Program for Cancer Survivors is an effective treatment?

The available research shows that using varenicline, a drug included in the Smoking Cessation + Pain Management Program, is more effective than other options like nicotine patches or bupropion for helping people quit smoking. Varenicline has been shown to increase the chances of quitting smoking by more than double compared to a placebo. Additionally, combining varenicline with nicotine replacement therapy can provide even more benefits. This suggests that the program, which includes these effective components, is a strong option for helping cancer survivors quit smoking. ^{1 2 3 4 5}

What data supports the effectiveness of the smoking cessation and pain management treatment for cancer survivors?

Research shows that using drugs like varenicline, bupropion, and nicotine replacement therapy can significantly increase the chances of quitting smoking compared to not using any medication. Varenicline, in particular, has been found to be more effective than other options, and combining it with nicotine replacement therapy can provide additional benefits. ^{1 2 3 4 5}

What safety data exists for smoking cessation treatments like varenicline?

Varenicline, also known as Chantix, is used for smoking cessation and has been shown to be effective in reducing nicotine withdrawal symptoms and cravings. However, there are safety concerns, particularly regarding neuropsychiatric side effects, seizures, and interactions with alcohol. The FDA has issued warnings about these risks. Despite these concerns, regulatory agencies consider varenicline to have a favorable benefit/risk profile, but patients should be closely monitored for neuropsychiatric symptoms. Bupropion and nicotine replacement therapies are also used for smoking cessation, each with their own safety profiles. Special populations, such as those with psychiatric comorbidities, pregnant women, and adolescents, may require additional considerations. ^{3 5 6 7 8}

Is the Smoking Cessation + Pain Management Program for Cancer Survivors safe?

Varenicline, a drug used in smoking cessation, has been associated with some safety concerns, including neuropsychiatric side effects and potential interactions with alcohol. Despite these concerns, regulatory agencies consider varenicline and similar treatments to have a favorable benefit/risk profile, but patients should be closely monitored for any adverse effects. ^{3 5 6 7 8}

Is the drug Varenicline a promising treatment for helping cancer survivors quit smoking?

Yes, Varenicline is a promising drug for helping people quit smoking. It works by reducing withdrawal symptoms and making smoking less enjoyable. Studies show it can significantly increase the chances of quitting compared to not using any medication. ^{2 3 5 7 9}

How is the Smoking Cessation + Pain Management Program for Cancer Survivors treatment different from other smoking cessation treatments?

This treatment is unique because it combines smoking cessation with pain management specifically for cancer survivors, using varenicline, which helps reduce nicotine withdrawal symptoms and cravings. Unlike standard smoking cessation programs, this approach addresses both smoking and pain, which are significant concerns for cancer survivors. ^{2 3 5 7 9}

Research Team

Kathryn I Pollak, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for cancer survivors over 18 who have smoked at least 100 cigarettes in their lifetime, currently smoke 5+ a day, and are experiencing pain. They should be willing to quit smoking, not in another cessation study, speak English, diagnosed with cancer within the last 5 years and have a life expectancy of at least one year.

Inclusion Criteria

I am a cancer patient at one of the specified hospitals.

You smoke at least 5 cigarettes a day in the past week.

I was diagnosed with cancer within the last 5 years.

Exclusion Criteria

I have hearing difficulties.

I am able to understand and give consent for my treatment.

I am considered too ill to take part in the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combined behavioral smoking cessation and pain management intervention with varenicline

12 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in smoking cessation, pain management, and quality of life

3 months

Surveys at baseline, post-intervention, and 3 months post-intervention

Treatment Details

Interventions

• Smoking cessation and pain management intervention
• Varenicline

Trial Overview Project HOPES aims to test a new program designed for cancer survivors that combines smoking cessation support with pain management. The intervention includes Varenicline—a medication used to help people stop smoking—and other strategies tailored for individuals dealing with both issues.

Participant Groups

Group I: Study population Experimental Treatment 2 Interventions

All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.

Smoking cessation and pain management intervention is already approved in United States, European Union for the following indications:

Approved in United States as Nicotine replacement therapy for:

• Smoking cessation

Approved in United States as Varenicline for:

• Smoking cessation

Approved in United States as Bupropion for:

• Smoking cessation
• Depression

Approved in European Union as Nicotine replacement therapy for:

• Smoking cessation

Approved in European Union as Varenicline for:

• Smoking cessation

Approved in European Union as Bupropion for:

• Smoking cessation
• Depression

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

The guideline panel made five strong recommendations for smoking cessation pharmacotherapy, emphasizing the use of varenicline over nicotine patches and bupropion, even for individuals with psychiatric conditions, and suggesting extended treatment durations beyond 12 weeks.

Two conditional recommendations were also made, including the combination of a nicotine patch with varenicline and the preference for varenicline over electronic cigarettes, aiming to enhance the effectiveness of tobacco-dependence treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. An Official American Thoracic Society Clinical Practice Guideline. Leone, FT., Zhang, Y., Evers-Casey, S., et al.[2021]

An empathic and personalized smoking cessation intervention program, with extended assistance and follow-up, is the most effective way to prevent serious health issues like heart disease and cancer in tobacco users, aiming for complete cessation rather than just reduction.

Current guidelines for smoking cessation, based on the Transtheoretical Model and the 'Five A's' (Ask, Advise, Assess, Assist, Arrange), provide a structured approach for clinicians, but these interventions are often underutilized due to a lack of training and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation in primary care: maximizing intervention strategies. Anczak, JD., Nogler, RA.[2022]

The five A's framework (ask, advise, assess, assist, arrange) is essential for physicians to effectively promote smoking cessation, emphasizing the need to assess patients' motivation and provide repeated encouragement to quit smoking.

Pharmacologic support, such as nicotine replacement therapies, bupropion, and varenicline, can significantly double the success rate of quitting, but special considerations are needed for certain populations, like pregnant women and those with specific cardiovascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting smoking cessation. Larzelere, MM., Williams, DE.[2018]

Combining varenicline with oral nicotine replacement therapy (NRT) and using smartphone medication reminders led to more days of smoking abstinence compared to using varenicline alone, suggesting that this combination may enhance smoking cessation efforts.

Participants who received smartphone reminders adhered to their varenicline medication more consistently and reported higher usage of NRT, indicating that reminders can improve medication adherence, although combining medications may lead to lower adherence overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial. Sifat, M., Hébert, ET., Ahluwalia, JS., et al.[2023]

Varenicline is the most effective first-line pharmacotherapy for smoking cessation, showing a significant effect compared to placebo with an odds ratio of 2.27, followed by bupropion (1.69) and nicotine replacement therapy (1.60).

Despite some safety concerns, regulatory agencies deem bupropion and varenicline to have a favorable benefit/risk profile, but healthcare providers should monitor patients for potential neuropsychiatric symptoms, especially in those with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. Aubin, HJ., Luquiens, A., Berlin, I.[2022]

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]

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]

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]

Smoking cessation is crucial for lung cancer patients as it improves treatment efficacy, reduces side effects, and enhances survival rates; continued smoking can lead to worse outcomes and lower quality of life.

Combined behavioral and pharmacological therapies, including nicotine replacement and bupropion, are effective and safe for helping cancer patients quit smoking, with more intensive and frequent contact leading to higher success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Smoking cessation in patients with lung cancer]. Quantin, X., Stoebner-Delbarre, A., Guichenez, P., et al.[2008]

References

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

Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. An Official American Thoracic Society Clinical Practice Guideline. [2021]

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

Tobacco cessation in primary care: maximizing intervention strategies. [2022]

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

Promoting smoking cessation. [2018]

4. Canada pubmed.ncbi.nlm.nih.gov

Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]

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

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

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

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

9. France pubmed.ncbi.nlm.nih.gov

[Smoking cessation in patients with lung cancer]. [2008]