Smoking Cessation + Pain Management Program for Cancer Survivors
Recruiting in Palo Alto (17 mi)
Overseen byKathryn I Pollak, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Duke University
No Placebo Group
Prior Safety Data
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.
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.
12345What 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.
35678Is 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.
23579Eligibility 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.
+7 more
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.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Study populationExperimental Treatment2 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, United States, United States, European Union, European Union, 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Health SystemDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. An Official American Thoracic Society Clinical Practice Guideline. [2021]Background: Current tobacco treatment guidelines have established the efficacy of available interventions, but they do not provide detailed guidance for common implementation questions frequently faced in the clinic. An evidence-based guideline was created that addresses several pharmacotherapy-initiation questions that routinely confront treatment teams.Methods: Individuals with diverse expertise related to smoking cessation were empaneled to prioritize questions and outcomes important to clinicians. An evidence-synthesis team conducted systematic reviews, which informed recommendations to answer the questions. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach was used to rate the certainty in the estimated effects and the strength of recommendations.Results: The guideline panel formulated five strong recommendations and two conditional recommendations regarding pharmacotherapy choices. Strong recommendations include using varenicline rather than a nicotine patch, using varenicline rather than bupropion, using varenicline rather than a nicotine patch in adults with a comorbid psychiatric condition, initiating varenicline in adults even if they are unready to quit, and using controller therapy for an extended treatment duration greater than 12 weeks. Conditional recommendations include combining a nicotine patch with varenicline rather than using varenicline alone and using varenicline rather than electronic cigarettes.Conclusions: Seven recommendations are provided, which represent simple practice changes that are likely to increase the effectiveness of tobacco-dependence pharmacotherapy.
Tobacco cessation in primary care: maximizing intervention strategies. [2022]The most effective preventive intervention that a clinician can provide for tobacco-using patients against heart disease, cancer, cerebrovascular disease and chronic obstructive pulmonary disease is an empathic, personalized smoking cessation intervention program with extended assistance and follow-up. The goal of the intervention must be complete smoking cessation. Reduction provides no direct health benefits to the individual smoker. Interventions are readily available, but underutilized, in part due to lack of clinician training and organizational support. The present article summarizes the current guidelines for smoking cessation interventions as a framework from which to start. The guidelines incorporate the Transtheoretical Model of patient behavioral change and the "Five A's": Ask, Advise, Assess, Assist and Arrange. Pharmacotherapeutic tools, including nicotine replacement therapies (nicotine gums, patches, nasal sprays, inhalers and new therapies) and non-nicotine therapies (bupropion, clonidine, nortriptyline and other antidepressants and anxiolytics) are considered. Adherence validation methods, new approaches to tobacco and addiction treatment that appear in the recent research literature are reviewed. Beyond this framework, specific categories of tobacco users (including smokeless tobacco users), cultural and ethnic minorities, adolescents using snuff and bidis, women, Medicaid recipients, and users of multiple forms of tobacco require special consideration. With this framework and the modifications that may be required for specific categories of patients, practicing clinicians can incorporate into daily practice a successful tobacco cessation intervention program with quit rates approaching 20%.
Promoting smoking cessation. [2018]Cigarette smoking causes significant morbidity and mortality in the United States. Physicians can use the five A's framework (ask, advise, assess, assist, arrange) to promote smoking cessation. All patients should be asked about tobacco use and assessed for motivation to quit at every clinical encounter. Physicians should strongly advise patients to quit smoking, and use motivational interviewing techniques for patients who are not yet willing to stop smoking. Clinical contacts with unmotivated patients should emphasize the rewards and relevance of quitting, as well as the risks of smoking and anticipated barriers to abstinence. These messages should be repeated at every opportunity. Appropriate patients should be offered pharmacologic assistance in quitting, such as nicotine replacement therapies, bupropion, and varenicline. Use of pharmacologic support during smoking cessation can double the rate of successful abstinence. Using more than one type of nicotine replacement therapy ("patch plus" method) and combining these therapies with bupropion provide additional benefit. However, special populations pose unique challenges in pharmacotherapy for smoking cessation. Nicotine replacement therapies increase the risk of birth defects and should not be used during pregnancy. They are usually safe in patients with cardiovascular conditions, except for those with unstable angina or within two weeks of a coronary event. Varenicline may increase the risk of coronary events. Nicotine replacement therapies are safe for use in adolescents; however, they are less effective than in adults. Physicians also should arrange to have repeated contact with smokers around their quit date to reinforce cessation messages.
Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial. [2023]Varenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied. In addition, smoking cessation medication adherence is often poor, thus, challenging the ability to evaluate medication efficacy.
Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]Strategies for assisting smoking cessation include behavioural counselling to enhance motivation and to support attempts to quit and pharmacological intervention to reduce nicotine reinforcement and withdrawal from nicotine. Three drugs are currently used as first line pharmacotherapy for smoking cessation, nicotine replacement therapy, bupropion and varenicline. Compared with placebo, the drug effect varies from 2.27 (95% CI 2.02, 2.55) for varenicline, 1.69 (95% CI 1.53, 1.85) for bupropion and 1.60 (95% CI 1.53, 1.68) for any form of nicotine replacement therapy. Despite some controversy regarding the safety of bupropion and varenicline, regulatory agencies consider these drugs as having a favourable benefit/risk profile. However, given the high rate of psychiatric comorbidity in dependent smokers, practitioners should closely monitor patients for neuropsychiatric symptoms. Second-line pharmacotherapies include nortriptyline and clonidine. This review also offers an overview of pipeline developments and issues related to smoking cessation in special populations such as persons with psychiatric comorbidity and pregnant and adolescent smokers.
Treatment of nicotine dependence with Chantix (varenicline). [2015]Varenicline is the generic name for Chantix, the newest drug available for the treatment of tobacco dependence. In a randomized controlled clinical trial, the abstinence rate at 1 year for patients using varencline was superior to that of patients in the group using bupropion SR (Zyban) and in the placebo group (11). Varenicline reduces nicotine withdrawal symptoms, cigarette craving and nicotine satisfaction. Post-market reports prompted a warning of serious adverse neuropsychiatric events in patients taking varenicline. As is the case with any surgical procedure and/or prescription medication, full disclosure of the risks and benefits should be discussed with the patient. The significant health benefits of quitting smoking should be weighed against the individual's risk of adverse events associated with the use of varenicline for smoking cessation.
Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. [2023]Varenicline, a partial agonist at the alpha4beta2 nicotinic acetylcholine receptor, has the potential to aid smoking cessation by relieving nicotine withdrawal symptoms and reducing the rewarding properties of nicotine.
Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. [2018]Smoking cessation remains a positive therapeutic goal and should be encouraged for the millions of individuals who continue to smoke and struggle to quit. While psychiatric nurses should encourage patients to start or continue smoking cessation therapies, they must be aware of the additional safety concerns relating to the use of varenicline (Chantix). Research published subsequent to the last clinical update in this journal (Tobin, 2007 ) has prompted additional warnings from the Food and Drug Administration concerning varenicline for smoking cessation therapy. In particular, clinicians need to be aware of increased concerns about varenicline's association with neuropsychiatric side effects, seizures, and alcohol interactions.
[Smoking cessation in patients with lung cancer]. [2008]Smoking cessation is an important part of the management of patients with lung cancer. Continued smoking has been found to diminish treatment efficacy, to exacerbate side effects and to have a detrimental effect on survival. Smoking increases postoperative pulmonary complications and tolerance and efficacy of medical treatment (chemotherapy, targeted therapy, radiotherapy) are diminished. Moreover, the quality of life of current smokers is lower and the risk of a second primary malignancy is increased. Hospitalization is a good opportunity to propose smoking cessation. Clinical practice guidelines recommend the use of combined behavioral and pharmacological therapies. The efficacy of smoking cessation programs for cancer patients has been demonstrated. There is a clear dose-response relationship between number of contacts, intensity level of person-to-person contact and total amount of contact time. Multidisciplinary approaches increase abstinence rates. First line phamacotherapies (nicotine replacement therapy and sustained-release antidepressant bupropion) have been found to be safe and effective. Varenicline is a new drug for smoking cessation but it remains to be evaluated in oncology patients.