Smoking CessationPhase 2TTOPNCT04634071
Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
A Phase 2 study testing Varenicline, Bupropion and Long-acting nicotine replacement therapy in people with Smoking Cessation and Cancer, Treatment-Related, run by Joseph Valentino, MD at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Cancer, Treatment-Related
- What is being tested?
- Varenicline, Bupropion and Long-acting nicotine replacement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Jan 2021to 2 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed or recurrent tobacco related malignancy
- 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
Who cannot join
- allergy to buproprion, varenicline and transdermal medicine
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Med Center Health
Bowling Green, Kentucky, 42101
University Of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303
About this study
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.
Read the detailed description
Background Cigarette smoking is associated with decreased survival and decreased efficacy of cancer therapy in those with smoking related malignancies. There is limited of study of smoking cessation for cancer patients being treated in regions with high tobacco use such as Kentucky. There is little study of cessation implementation in the community cancer treatment setting where the majority of cancer patients receive their cancer therapy. Most smokers have significant exposure to information and personal experience with tobacco treatments which, in some cases, leads to profound preferences. The effect of incorporating these patient preferences into tobacco treatment planning has not been studied or quantified.
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
- Smoking Cessation, Cancer, Treatment-Related
- Being tested
- Varenicline, Bupropion, Long-acting nicotine replacement therapy, Low-intensity counseling, High-intensity counseling
- Keywords
- Addiction, Cancer Therapy, Tobacco, nicotine
- Medical subject headings
- Smoking Cessation, Neoplasms, Second Primary, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
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.
BupropionDrug
Also called Wellbutrin XL, Forfivo XL, Zyban, and Aplenzin
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 therapyDrug
Also called Transdermal nicotine
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Low-intensity counselingBehavioural
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 counselingBehavioural
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 therapyOther
Also called nicotine gum, nicotine losenges, nicotine spray
Participants in this group will not receive per required need nicotine replacement therapy.
Nicotine Replacement ProductsDrug
Also called nicotine gum, nicotine losenges, nicotine spray
Participants in this group will receive per required need nicotine replacement therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Nicotine, Intense Counselling and NRT | Experimental | 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. Receives: Drug: Long-acting nicotine replacement therapy; Behavioral: High-intensity counseling; Drug: Nicotine Replacement Products |
| Group 2: Buproprion, Intense Counselling and NRT | Experimental | 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. Receives: Drug: Bupropion; Behavioral: High-intensity counseling; Drug: Nicotine Replacement Products |
| Group 3: Varenicline, Intense Counselling and NRT | Experimental | 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. Receives: Drug: Varenicline; Behavioral: High-intensity counseling; Drug: Nicotine Replacement Products |
| Group 4: Nicotine, Intense Counselling | Experimental | 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. Receives: Drug: Long-acting nicotine replacement therapy; Behavioral: High-intensity counseling; Other: No nicotine replacement therapy |
| Group 5: Buproprion, Intense Counselling | Experimental | 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. Receives: Drug: Bupropion; Behavioral: High-intensity counseling; Other: No nicotine replacement therapy |
| Group 6: Varenicline, Intense Counselling | Experimental | 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. Receives: Drug: Varenicline; Behavioral: High-intensity counseling; Other: No nicotine replacement therapy |
| Group 7: Nicotine, Minimal Counselling and NRT | Experimental | 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. Receives: Drug: Long-acting nicotine replacement therapy; Behavioral: Low-intensity counseling; Drug: Nicotine Replacement Products |
| Group 8: Buproprion, Minimal Counselling and NRT | Experimental | 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. Receives: Drug: Bupropion; Behavioral: Low-intensity counseling; Drug: Nicotine Replacement Products |
| Group 9: Varenicline, Minimal Counselling and NRT | Experimental | 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. Receives: Drug: Varenicline; Behavioral: Low-intensity counseling; Drug: Nicotine Replacement Products |
| Group 10: Nicotine, Minimal Counselling | Experimental | 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. Receives: Drug: Long-acting nicotine replacement therapy; Behavioral: Low-intensity counseling; Other: No nicotine replacement therapy |
| Group 11: Buproprion, Minimal Counselling | Experimental | 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. Receives: Drug: Bupropion; Behavioral: Low-intensity counseling; Other: No nicotine replacement therapy |
| Group 12: Varenicline, Minimal Counselling | Experimental | 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. Receives: Drug: Varenicline; Behavioral: Low-intensity counseling; Other: No nicotine replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cigarette use
Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.
Measured: at week 8
Secondary outcomes (5)
Preferred treatment
Proportion of participants preferring the treatment plan.
Measured: at baseline
Prevalence of cigarette use
Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.
Measured: 6 months
Change in Cigarette Use
Cigarette use will be recorded at weeks one, four, eight and at 6 months.
Measured: 6 months
Drug Compliance
Subjects who complete 75% of the planned dosages of therapy will be considered compliant.
Measured: 6 months
Counselling Compliance
Subjects who complete 60% of planned therapy sessions will be considered compliant.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start12 Jan 2021
- Primary completion2 Jan 2026
- Study completion2 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a parallel design. However, it is part of a broader sequential cohort design to compare the effects of preference driven tobacco treatment upon cessation versus effects of a previous cohort from a separate randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Valentino, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph Valentino, MD, University of Kentucky
- Investigators
- Joseph Valentino, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634071
- Sponsor's protocol ID
- MCC-20-MULTI-34
- Acronym
- TTOP
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
- ClinicalTrials.gov ID
- NCT04634071
- Acronym / sponsor ID
- TTOP / MCC-20-MULTI-34
- Conditions
- Smoking Cessation, Cancer, Treatment-Related
- Keywords
- Addiction, Cancer Therapy, Tobacco, nicotine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Joseph Valentino, MDUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Cigarette smoking is associated with decreased survival and decreased efficacy of cancer therapy in those with smoking related malignancies. There is limited of study of smoking cessation for cancer patients being treated in regions with high tobacco use such as Kentucky. There is little study of cessation implementation in the community cancer treatment setting where the majority of cancer patients receive their cancer therapy. Most smokers have significant exposure to information and personal experience with tobacco treatments which, in some cases, leads to profound preferences. The effect of incorporating these patient preferences into tobacco treatment planning has not been studied or quantified.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- This trial is a parallel design. However, it is part of a broader sequential cohort design to compare the effects of preference driven tobacco treatment upon cessation versus effects of a previous cohort from a separate randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Nicotine, Intense Counselling and NRT | Experimental | Drug: Long-acting nicotine replacement therapy, Behavioral: High-intensity counseling, Drug: Nicotine Replacement ProductsPatients 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. |
| Group 2: Buproprion, Intense Counselling and NRT | Experimental | Drug: Bupropion, Behavioral: High-intensity counseling, Drug: Nicotine Replacement ProductsPatients 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. |
| Group 3: Varenicline, Intense Counselling and NRT | Experimental | Drug: Varenicline, Behavioral: High-intensity counseling, Drug: Nicotine Replacement ProductsPatients 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. |
| Group 4: Nicotine, Intense Counselling | Experimental | Drug: Long-acting nicotine replacement therapy, Behavioral: High-intensity counseling, Other: No nicotine replacement therapyPatients 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. |
| Group 5: Buproprion, Intense Counselling | Experimental | Drug: Bupropion, Behavioral: High-intensity counseling, Other: No nicotine replacement therapyPatients 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. |
| Group 6: Varenicline, Intense Counselling | Experimental | Drug: Varenicline, Behavioral: High-intensity counseling, Other: No nicotine replacement therapyPatients 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. |
| Group 7: Nicotine, Minimal Counselling and NRT | Experimental | Drug: Long-acting nicotine replacement therapy, Behavioral: Low-intensity counseling, Drug: Nicotine Replacement ProductsPatients 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. |
| Group 8: Buproprion, Minimal Counselling and NRT | Experimental | Drug: Bupropion, Behavioral: Low-intensity counseling, Drug: Nicotine Replacement ProductsPatients 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. |
| Group 9: Varenicline, Minimal Counselling and NRT | Experimental | Drug: Varenicline, Behavioral: Low-intensity counseling, Drug: Nicotine Replacement ProductsPatients 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. |
| Group 10: Nicotine, Minimal Counselling | Experimental | Drug: Long-acting nicotine replacement therapy, Behavioral: Low-intensity counseling, Other: No nicotine replacement therapyPatients 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. |
| Group 11: Buproprion, Minimal Counselling | Experimental | Drug: Bupropion, Behavioral: Low-intensity counseling, Other: No nicotine replacement therapyPatients 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. |
| Group 12: Varenicline, Minimal Counselling | Experimental | Drug: Varenicline, Behavioral: Low-intensity counseling, Other: No nicotine replacement therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- newly diagnosed or recurrent tobacco related malignancy
- 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
Key exclusion criteria (12 listed)
- allergy to buproprion, varenicline and transdermal medicine
- history of suicide attempt
- hospitalized for psychiatric illness within past 2 years
- history of active or uncontrolled eating disorder
- uncontrolled epilepsy or seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: ChantixVarenicline 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. | Drug | Group 12: Varenicline, Minimal Counselling, Group 3: Varenicline, Intense Counselling and NRT, Group 6: Varenicline, Intense Counselling, Group 9: Varenicline, Minimal Counselling and NRT |
| BupropionAlso: Wellbutrin XL, Forfivo XL, Zyban, and AplenzinPatients 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. | Drug | Group 11: Buproprion, Minimal Counselling, Group 2: Buproprion, Intense Counselling and NRT, Group 5: Buproprion, Intense Counselling, Group 8: Buproprion, Minimal Counselling and NRT |
| Long-acting nicotine replacement therapyAlso: Transdermal nicotineNicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history. | Drug | Group 10: Nicotine, Minimal Counselling, Group 1: Nicotine, Intense Counselling and NRT, Group 4: Nicotine, Intense Counselling, Group 7: Nicotine, Minimal Counselling and NRT |
| Low-intensity counselingA study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length. | Behavioural | Group 10: Nicotine, Minimal Counselling, Group 11: Buproprion, Minimal Counselling, Group 12: Varenicline, Minimal Counselling, Group 7: Nicotine, Minimal Counselling and NRT, Group 8: Buproprion, Minimal Counselling and NRT, Group 9: Varenicline, Minimal Counselling and NRT |
| High-intensity counselingA 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. | Behavioural | Group 1: Nicotine, Intense Counselling and NRT, Group 2: Buproprion, Intense Counselling and NRT, Group 3: Varenicline, Intense Counselling and NRT, Group 4: Nicotine, Intense Counselling, Group 5: Buproprion, Intense Counselling, Group 6: Varenicline, Intense Counselling |
| No nicotine replacement therapyAlso: nicotine gum, nicotine losenges, nicotine sprayParticipants in this group will not receive per required need nicotine replacement therapy. | Other | Group 10: Nicotine, Minimal Counselling, Group 11: Buproprion, Minimal Counselling, Group 12: Varenicline, Minimal Counselling, Group 4: Nicotine, Intense Counselling, Group 5: Buproprion, Intense Counselling, Group 6: Varenicline, Intense Counselling |
| Nicotine Replacement ProductsAlso: nicotine gum, nicotine losenges, nicotine sprayParticipants in this group will receive per required need nicotine replacement therapy. | Drug | Group 1: Nicotine, Intense Counselling and NRT, Group 2: Buproprion, Intense Counselling and NRT, Group 3: Varenicline, Intense Counselling and NRT, Group 7: Nicotine, Minimal Counselling and NRT, Group 8: Buproprion, Minimal Counselling and NRT, Group 9: Varenicline, Minimal Counselling and NRT |
Primary outcome
Prevalence of cigarette use
Time frame: at week 8
Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.
5 secondary outcomes
Preferred treatment
Time frame: at baseline
Prevalence of cigarette use
Time frame: 6 months
Change in Cigarette Use
Time frame: 6 months
Drug Compliance
Time frame: 6 months
Counselling Compliance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Valentino, MD principal investigator
University of Kentucky
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline, Bupropion and Long-acting nicotine replacement therapy in people with Smoking Cessation and Cancer, Treatment-Related, run by Joseph Valentino, MD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cigarette use (time frame: at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.