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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

Must not have

unstable angina

serious arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is new or has returned and is linked to tobacco use.

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I have smoked the equivalent of 10 packs of cigarettes a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have unstable chest pain.

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I have a serious irregular heartbeat.

Select...

I am allergic to buproprion, varenicline, and patch medications.

Select...

I do not have uncontrolled seizures.

Select...

My blood pressure is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prevalence of cigarette use

Proportion of participants that quit smoking.

Secondary study objectives

Change in Cigarette Use

Counselling Compliance

Drug Compliance

+1 more

Other study objectives

Insurance coverage

Number of patients requiring financial assistance with medication.

Number of patients with alteration in therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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

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

Group XII: Group 10: Nicotine, Intense CounsellingExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupropion

2011

Completed Phase 4

~3310

Varenicline

2011