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Antidepressant

Smoking Cessation Strategies for Cancer (TTOP Trial)

Phase 2
Recruiting
Research Sponsored by Joseph Valentino, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
newly diagnosed or recurrent tobacco related malignancy
10-pack year history of cigarette smoking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

TTOP Trial Summary

This trial will test different smoking cessation strategies to see which one is most effective for patients receiving treatment for tobacco-related cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions to nicotine replacements such as skin irritation from patches; mood changes, insomnia or headache from Bupropion; nausea, sleep problems or unusual dreams from Varenicline; and increased blood pressure.

TTOP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is new or has returned and is linked to tobacco use.
Select...
I have smoked the equivalent of 10 packs of cigarettes a year.

TTOP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants that quit smoking.
Secondary outcome measures
Change in Cigarette Use
Counselling Compliance
Drug Compliance
+2 more
Other outcome measures
Insurance coverage
Number of patients requiring financial assistance with medication.
Number of patients with alteration in therapy

TTOP Trial Design

12Treatment groups
Experimental Treatment
Group I: Group : Varenicline, Intense CounsellingExperimental Treatment3 Interventions
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.
Group II: Group 9: Nicotine, Intense Counselling and NRTExperimental Treatment3 Interventions
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.
Group III: Group 8: Buproprion, Minimal CounsellingExperimental Treatment3 Interventions
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.
Group IV: Group 7: Buproprion, Minimal Counselling and NRTExperimental Treatment3 Interventions
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.
Group V: Group 6: Buproprion, Intense CounsellingExperimental Treatment3 Interventions
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.
Group VI: Group 5: Buproprion, Intense Counselling and NRTExperimental Treatment3 Interventions
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.
Group VII: Group 4: Varenicline, Minimal CounsellingExperimental Treatment3 Interventions
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.
Group VIII: Group 3: Varenicline, Minimal Counselling and NRTExperimental Treatment3 Interventions
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.
Group IX: Group 1: Varenicline, Intense Counselling and NRTExperimental Treatment3 Interventions
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.
Group X: Group 12: Nicotine, Minimal CounsellingExperimental Treatment3 Interventions
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.
Group XI: Group 11: Nicotine, Minimal Counselling and NRTExperimental Treatment3 Interventions
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.
Group XII: Group 10: Nicotine, Intense CounsellingExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupropion
2011
Completed Phase 4
~3310
Varenicline
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

Joseph Valentino, MDLead Sponsor

Media Library

Bupropion (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT04634071 — Phase 2
Cancer Research Study Groups: Group 10: Nicotine, Intense Counselling, Group 11: Nicotine, Minimal Counselling and NRT, Group 12: Nicotine, Minimal Counselling, Group 1: Varenicline, Intense Counselling and NRT, Group : Varenicline, Intense Counselling, Group 3: Varenicline, Minimal Counselling and NRT, Group 4: Varenicline, Minimal Counselling, Group 5: Buproprion, Intense Counselling and NRT, Group 6: Buproprion, Intense Counselling, Group 7: Buproprion, Minimal Counselling and NRT, Group 8: Buproprion, Minimal Counselling, Group 9: Nicotine, Intense Counselling and NRT
Cancer Clinical Trial 2023: Bupropion Highlights & Side Effects. Trial Name: NCT04634071 — Phase 2
Bupropion (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634071 — Phase 2
~38 spots leftby Jan 2026
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