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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help cancer survivors quit smoking and manage pain more effectively. Researchers are testing the feasibility and effectiveness of combining a smoking cessation program with varenicline, a medication that reduces cravings. Participants must have received a cancer diagnosis in the past five years, experience regular pain, and be willing to quit smoking. This trial suits those who smoke at least five cigarettes a day and have smoked over 100 cigarettes in their lifetime. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants the opportunity to benefit from established therapies.

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 is the safety track record for these treatments?

Research shows that the smoking cessation and pain management program can help people quit smoking while managing pain. Participants have found this supportive program well-received.

Regarding varenicline, studies have found it generally safe and effective for quitting smoking. Some individuals report mild side effects like nausea and trouble sleeping. The FDA has mentioned a potential cancer risk with long-term varenicline use, but there is no immediate risk for current users.

Overall, both the program and varenicline have undergone previous study and are generally considered safe, with only minor side effects reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this treatment because it combines a smoking cessation and pain management program with varenicline, offering a dual approach that addresses both smoking addiction and pain in cancer survivors. Unlike the standard of care, which typically involves separate treatments for smoking cessation and pain management, this integrated approach aims to simplify the process for patients by tackling both issues simultaneously. Varenicline, known for its effectiveness in helping people quit smoking, is used here alongside a comprehensive intervention designed to manage pain, potentially improving overall quality of life for cancer survivors. This combined method could lead to better adherence and outcomes compared to managing each condition independently.

What evidence suggests that this trial's treatments could be effective for cancer survivors?

Studies have shown that quitting smoking can greatly improve outcomes for cancer patients by lowering the risk of death and aiding recovery. Patients who stop smoking with the right support are two to three times more likely to succeed. Addressing smoking cessation alongside pain management can improve both issues simultaneously.

In this trial, all participants will receive a combined smoking cessation and pain management intervention, along with clinician-prescribed varenicline. Varenicline, a medication found to help cancer patients quit smoking, has been shown to increase the likelihood of successful cessation when taken as directed for 24 weeks. This drug can also enhance mood and cognitive function, which is especially beneficial for those dealing with cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Kathryn I Pollak, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10484062/

Smoking cessation interventions in patients diagnosed with ... According to findings from the previous studies, quitting smoking can significantly reduce mortality from all causes and is linked to better treatment results.

2. medrxiv.org medrxiv.org/content/10.1101/2025.01.11.25320383v1.full-text

Effectiveness of Smoking Cessation Interventions in ... This protocol outlines a systematic review and meta-analysis evaluating the effectiveness of smoking cessation interventions in cancer patients ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30328056/

A smoking cessation and pain management program for ... A combined smoking cessation and pain program might help improve both issues simultaneously.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2771608

Effect of Sustained Smoking Cessation Counseling and ... Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment ...

5. medicine.washu.edu medicine.washu.edu/news/national-study-shows-cancer-centers-help-patients-stop-smoking/

Study supports urging smoking-cessation treatment to ... “Patients receiving tobacco treatment were two to three times more successful in quitting than untreated people, and cancer treatment was significantly more ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555596/

Interventions for Smoking Cessation and Treatments ... - NCBI Among program completers (24% of the total sample), quit rates were 33% for 7-day point prevalence and 28% for 30-day point prevalence, and 88% of participants ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06749

Smoking Cessation and Pain Management Intervention ... This phase IV trial studies how well a smoking cessation and pain management behavioral intervention works for cancer patients who smoke and have pain.