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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 moreOther 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
Eligibility Criteria:
This trial includes the following eligibility 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.My cancer is new or has returned and is linked to tobacco use.I have a serious irregular heartbeat.I had a heart attack within the last 3 months.I have smoked the equivalent of 10 packs of cigarettes a year.You are expected to live for at least one more year.I am allergic to buproprion, varenicline, and patch medications.I do not have uncontrolled seizures.You are either pregnant or breastfeeding.My blood pressure is not well-controlled.I am currently enrolled in a program to quit smoking.You smoked a cigarette within a month of being diagnosed with cancer.You have a history of an untreated or uncontrolled eating disorder.You have smoked a cigarette within the past 4 weeks before the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 10: Nicotine, Intense Counselling
- Group 2: Group 11: Nicotine, Minimal Counselling and NRT
- Group 3: Group 12: Nicotine, Minimal Counselling
- Group 4: Group 1: Varenicline, Intense Counselling and NRT
- Group 5: Group : Varenicline, Intense Counselling
- Group 6: Group 3: Varenicline, Minimal Counselling and NRT
- Group 7: Group 4: Varenicline, Minimal Counselling
- Group 8: Group 5: Buproprion, Intense Counselling and NRT
- Group 9: Group 6: Buproprion, Intense Counselling
- Group 10: Group 7: Buproprion, Minimal Counselling and NRT
- Group 11: Group 8: Buproprion, Minimal Counselling
- Group 12: Group 9: Nicotine, Intense Counselling and NRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have prior investigations been conducted into High-intensity counseling?
"Presently, 113 trials are ongoing in regards to High-intensity counselling. Of these studies, 17 have progressed to Phase 3 status. The majority of the investigations related to this therapeutic approach is occurring in Charleston, South carolina; nonetheless there are 530 distinct sites conducting research into it."
Answered by AI
Is High-intensity counseling a risk-free intervention for individuals?
"Although there is anecdotal evidence of this intervention's safety, without any proof of efficacy the score for High-intensity counseling was 2 out of 3."
Answered by AI
Is this research endeavor actively seeking participants?
"This trial is actively recruiting, as reported on clinicaltrials.gov. The study was published to the registry on December 1st 2021 and then updated just last month (February 9th 2022)."
Answered by AI
What is the current sample size for this clinical investigation?
"Affirmative. Clinicaltrials.gov reports verify that this medical research, which was initially announced on December 1st 2021, is actively recruiting participants. A total of 96 individuals are needed from one centre."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What site did they apply to?
University Of Kentucky, Markey Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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