126 Participants Needed

Smoking Cessation Strategies for Cancer

(TTOP Trial)

Recruiting at 2 trial locations
JV
Overseen ByJoseph Valentino, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Smoking cessation has been shown to improve the effectiveness and reduce the morbidity of tobacco-related cancer treatments. We will identify effective smoking cessation strategies for patients who are receiving treatment for tobacco-related cancer. In this trial, patients' preferences in smoking cessation therapy will be the principal determinant by providers in developing a three component regimen of pharmaceutical therapy, counseling, and nicotine replacement therapy. This study will identify this cohort's preferences for smoking cessation strategies. We will then examine the impact of utilizing patient preferences upon cessation efficacy by directly comparing cessation success in this study with our recently completed study of the same population using the same tobacco treatments which were randomly assigned.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently taking varenicline or buproprion, you must not have taken them within one month of enrollment.

Is the smoking cessation treatment safe for humans?

Varenicline, bupropion, and nicotine replacement therapies are generally considered safe for smoking cessation, but there have been concerns about psychiatric disturbances with varenicline and bupropion. These treatments have not been associated with increased risks during pregnancy.12345

What makes the drug varenicline unique for smoking cessation in cancer patients?

Varenicline is unique because it is a selective nicotinic receptor partial agonist, specifically developed for smoking cessation, and has shown higher efficacy rates compared to bupropion and nicotine replacement therapies. It is particularly effective for cancer patients who continue to smoke, offering a novel approach compared to traditional nicotine-based treatments.36789

What data supports the effectiveness of the drugs used in the Smoking Cessation Strategies for Cancer trial?

Research shows that varenicline, bupropion, and nicotine replacement therapy (NRT) are effective for smoking cessation, with varenicline being slightly more effective than bupropion and NRT. These drugs approximately double the chances of quitting smoking for a year when used for three months.78101112

Who Is on the Research Team?

JV

Joseph Valentino, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals who have smoked within a month of their cancer diagnosis, have a significant history of smoking (10-pack year), and expect to live more than a year. They must be newly diagnosed or have recurrent tobacco-related cancer but can't join if they're allergic to certain quit-smoking meds, pregnant, recently had serious heart issues, uncontrolled seizures or hypertension, or are currently in another cessation program.

Inclusion Criteria

My cancer is new or has returned and is linked to tobacco use.
I have smoked the equivalent of 10 packs of cigarettes a year.
You are expected to live for at least one more year.
See 2 more

Exclusion Criteria

You have tried to harm yourself in the past by attempting suicide.
I have unstable chest pain.
I have not taken varenicline or buproprion in the last month.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized smoking cessation regimen including pharmaceutical therapy, counseling, and nicotine replacement therapy based on their preferences

8 weeks
Weekly visits for counseling and monitoring

Follow-up

Participants are monitored for smoking cessation success and compliance with the treatment plan

6 months
Visits at weeks 1, 4, 8, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Bupropion
  • High-intensity counseling
  • Long-acting nicotine replacement therapy
  • Low-intensity counseling
  • Nicotine Replacement Products
  • Varenicline
Trial Overview The study aims to find the best way to help patients with tobacco-related cancers quit smoking by letting them choose their treatment from options like medications (Bupropion and Varenicline), nicotine replacement products, and counseling. Success rates will be compared with previous studies where treatments were assigned randomly rather than chosen.
How Is the Trial Designed?
12Treatment groups
Experimental Treatment
Group I: Group : Varenicline, Intense CounsellingExperimental Treatment3 Interventions
Group II: Group 9: Nicotine, Intense Counselling and NRTExperimental Treatment3 Interventions
Group III: Group 8: Buproprion, Minimal CounsellingExperimental Treatment3 Interventions
Group IV: Group 7: Buproprion, Minimal Counselling and NRTExperimental Treatment3 Interventions
Group V: Group 6: Buproprion, Intense CounsellingExperimental Treatment3 Interventions
Group VI: Group 5: Buproprion, Intense Counselling and NRTExperimental Treatment3 Interventions
Group VII: Group 4: Varenicline, Minimal CounsellingExperimental Treatment3 Interventions
Group VIII: Group 3: Varenicline, Minimal Counselling and NRTExperimental Treatment3 Interventions
Group IX: Group 1: Varenicline, Intense Counselling and NRTExperimental Treatment3 Interventions
Group X: Group 12: Nicotine, Minimal CounsellingExperimental Treatment3 Interventions
Group XI: Group 11: Nicotine, Minimal Counselling and NRTExperimental Treatment3 Interventions
Group XII: Group 10: Nicotine, Intense CounsellingExperimental Treatment3 Interventions

Bupropion is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Wellbutrin for:
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Approved in European Union as Wellbutrin for:
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Approved in Canada as Zyban for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joseph Valentino, MD

Lead Sponsor

Trials
1
Recruited
130+

Published Research Related to This Trial

In a 52-week study involving 746 participants, varenicline was found to be significantly more effective than transdermal nicotine replacement therapy (NRT) for smoking cessation, with a continuous abstinence rate of 55.9% compared to 43.2% for NRT during the last 4 weeks of treatment.
Varenicline also led to significantly lower levels of craving, withdrawal symptoms, and smoking satisfaction compared to NRT, although it had a higher incidence of nausea as a side effect (37.2% for varenicline vs. 9.7% for NRT).
Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial.Aubin, HJ., Bobak, A., Britton, JR., et al.[2022]
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.
Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice.Aubin, HJ., Luquiens, A., Berlin, I.[2022]
In a study of 11,968 participants in Taiwan, varenicline was found to be more effective than nicotine replacement therapy (NRT) patch in achieving smoking abstinence, with higher odds ratios for 7-day, 1-month, and 6-month point-prevalence rates.
Varenicline showed significant benefits for both women and smokers with light to moderate nicotine dependence, indicating its effectiveness across different demographics and levels of nicotine addiction.
Comparative Effectiveness of Smoking Cessation Medications: A National Prospective Cohort From Taiwan.Chang, PY., Lo, PC., Chang, HC., et al.[2018]

Citations

Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. [2022]
Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]
Comparative Effectiveness of Smoking Cessation Medications: A National Prospective Cohort From Taiwan. [2018]
Which drug to be used in smoking cessation? [2017]
Comparing the tolerability and effectiveness of two treatment regimens in a smoking clinic. [2019]
Smoking cessation medicines and e-cigarettes: a systematic review, network meta-analysis and cost-effectiveness analysis. [2022]
Effects of varenicline and bupropion sustained-release use plus intensive smoking cessation counseling on prolonged abstinence from smoking and on depression, negative affect, and other symptoms of nicotine withdrawal. [2022]
[Drug of the month. Varenicline (Champix)]. [2015]
Mental health status of varenicline and bupropion users during a quit attempt compared to current smokers, other quitters, and non-smokers. [2022]
Use of smoking cessation pharmacotherapies during pregnancy is not associated with increased risk of adverse pregnancy outcomes: a population-based cohort study. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Pharmacotherapy for tobacco cessation: nicotine agonists, antagonists, and partial agonists. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Smoking cessation with varenicline, a selective alpha4beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. [2022]
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