Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
NCT ID: NCT04634071
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2021-01-12
2026-01-02
Brief Summary
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Detailed Description
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Study Design Phase II therapeutic clinical trial.
Setting University of Kentucky Markey Cancer Center (MCC) and its affiliate research network of Community Cancer Centers (MCCRN)
Methods Ninety-three subjects will be selected. All subjects will be active smoking oncology patients with a diagnosis of smoking related malignancy who are beginning a new course of therapy. In conjunction with their treating clinician, all subjects will be counseled and then select one of 12 cessation strategies. This will include a choice of continuous pharmacologic agent (veranicline, bupropion or transdermal nicotine patch), counseling strategy (11 session high intensity motivational based counseling or single session low intensity counseling), and whether or not to use as needed nicotine (gum, lozenges or spray).
Data Analysis All subjects will be followed for six months. The primary endpoint will be a carbon monoxide monitoring confirmed negative seven-day point prevalence report of cessation at eight weeks. Data will then be analyzed and compared with a completed randomized clinical trial of the same treatment strategies in the same population of subjects where the cessation strategy was assigned (historical control). The proportion of subjects that have quit at week eight will be compared to the historical control proportion (namely, whether Ho:p=po vs Ha: p\>po). This will be assessed using a z-score for a binomial proportion which will test whether the underlying proportion quitting at eight weeks (p) differs from the control proportion (po ranging from 0.215 to 0.26) estimated from our recently completed randomized trial of these same 12 cessation strategies.
Revised Enrollment Number: Effective with Amendment 2, Expand targeted enrollment from 96 to 126 due to higher than expected drop-out/censoring rate in order to evaluate the primary endpoint
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: Varenicline, Intense Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.
Varenicline
Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.
Group : Varenicline, Intense Counselling
Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.
Varenicline
Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.
Group 3: Varenicline, Minimal Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.
Varenicline
Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.
Group 4: Varenicline, Minimal Counselling
Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.
Varenicline
Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.
Group 5: Buproprion, Intense Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.
Bupropion
Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.
Group 6: Buproprion, Intense Counselling
Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.
Bupropion
Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.
Group 7: Buproprion, Minimal Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.
Bupropion
Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.
Group 8: Buproprion, Minimal Counselling
Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.
Bupropion
Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.
Group 9: Nicotine, Intense Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.
Long-acting nicotine replacement therapy
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.
Group 10: Nicotine, Intense Counselling
Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.
Long-acting nicotine replacement therapy
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.
Group 11: Nicotine, Minimal Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.
Long-acting nicotine replacement therapy
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.
Group 12: Nicotine, Minimal Counselling
Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.
Long-acting nicotine replacement therapy
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.
Interventions
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Varenicline
Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
Bupropion
Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
Long-acting nicotine replacement therapy
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.
Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* smoked at least 1 cigarette within 4 weeks of study enrollment
* 10-pack year history of cigarette smoking
* smoked at least 1 cigarette within 1 month of cancer diagnosis
* life expectancy greater than 1 year
Exclusion Criteria
* history of suicide attempt
* hospitalized for psychiatric illness within past 2 years
* history of active or uncontrolled eating disorder
* uncontrolled epilepsy or seizure disorder
* pregnant or lactating
* within 3 months of myocardial infarction
* unstable angina
* uncontrolled hypertension
* serious arrhythmia
* history of taking varenicline or buproprion within one month of enrollment
* concurrent enrollment in tobacco cessation therapy
18 Years
ALL
No
Sponsors
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Joseph Valentino, MD
OTHER
Responsible Party
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Joseph Valentino, MD
Professor
Principal Investigators
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Joseph Valentino, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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Med Center Health
Bowling Green, Kentucky, United States
University Of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States
Countries
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Other Identifiers
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MCC-20-MULTI-34
Identifier Type: -
Identifier Source: org_study_id
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