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Smoking Cessation Program for Cancer
N/A
Waitlist Available
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients have smoked > 100 cigarettes in their lifetime and have smoked within the last 30 days
Subjects must read and speak fluent English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial looks at whether an enhanced tobacco intervention protocol (ETIP) is better than standard treatment at helping people with head and neck or lung cancer to stop smoking cigarettes.
Who is the study for?
This trial is for head and neck or lung cancer patients who are smokers, willing to quit, have a life expectancy of at least 6 months, speak English fluently, and are new patients at TJUH. Excluded are non-English speakers, those with allergies to NRT/bupropion/varenicline or severe skin reactions, unstable medical conditions, swallowing disorders, pregnant/breastfeeding women, certain medication users.Check my eligibility
What is being tested?
The study compares an Enhanced Tobacco Intervention Protocol (ETIP) with standard treatment in helping cancer patients reduce smoking. ETIP includes personalized counseling (in-person/telehealth), drug therapy options like nicotine replacement and medications bupropion/varenicline plus regular follow-ups.See study design
What are the potential side effects?
Possible side effects include allergic reactions to nicotine replacement or medications used (bupropion/varenicline), skin reactions like Steven's Johnson syndrome. Specific side effects from quitting smoking can also occur such as withdrawal symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have smoked more than 100 cigarettes in my life and have smoked in the last 30 days.
Select...
I can read and speak English fluently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Smoke
Secondary outcome measures
Cigarette abstinence at 1 and 6 months, as reported by patients
Proportion of patients having urine anabasine/anatabine levels of less than 2ng/ml
Other outcome measures
Biomarker analysis
Interest expressed in wellness practices
Likelihood of patient participation
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ETIP)Experimental Treatment6 Interventions
Patients receive nicotine replacement therapy via trans-dermal patch, gum, nasal spray, inhaler or lozenges for 12 weeks in the absence of unacceptable toxicity. Patients also receive bupropion PO QD BID or varenicline PO QD and BID for 24 weeks in the absence of unacceptable toxicity. Patients undergo 3 cessation counseling sessions in person, via telehealth or phone within 7 days of enrollment into study, 1 week after established quit date and 3 weeks after establishing quit date.
Group II: Arm II SOCActive Control3 Interventions
Participants randomly assigned to the standard treatment (ST) group will receive an in-office smoking cessation recommendation by the physician and referral to a quit line.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved
Varenicline
FDA approved
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,674 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known allergy or severe skin reaction to NRT.I am not currently experiencing uncontrolled psychiatric illness nor am I on psychiatric medications.I haven't had major surgery, serious fractures, or heart issues in the last 6 weeks.I have smoked more than 100 cigarettes in my life and have smoked in the last 30 days.I recently had a heart attack or have serious heart rhythm problems or chest pain.I cannot swallow pills due to a severe condition.I am able to understand and make decisions about my health care.I am currently taking anti-depressants.I can read and speak English fluently.I am open to talking about changing my smoking habits.I am fluent in English.You are allergic to bupropion or varenicline, or have had severe skin reactions like Steven's Johnson syndrome.I haven't used nicotine or tobacco products for the required time before and after my surgery.I recently stopped using alcohol, benzodiazepines, barbiturates, or antiepileptic drugs.I do not have a condition that increases my risk of seizures, such as a severe brain injury or eating disorder.I am a new patient at TJUH or Methodist with suspected or newly diagnosed head, neck, or lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (ETIP)
- Group 2: Arm II SOC
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
What conditions is Varenicline typically utilized to treat?
"Varenicline is most commonly prescribed to address Attention Deficit Hyperactivity Disorder (ADHD), but has also been used with success in treating Seasonal Affective Disorder, smoking cessation and nicotine addiction."
Answered by AI
Are there any available openings for participants in this research endeavor?
"According to the records held on clinicaltrials.gov, this research project is actively looking for subjects and has been since August 19th 2020. The most recent update was issued on September 14th 2022."
Answered by AI
How many participants have been accepted into this clinical trial thus far?
"Affirmative. Clinicaltrials.gov reveals this medical investigation is searching for participants; it was initially posted on August 19th 2020 and the most recent update occurred on September 14th 2022. The clinical trial requires 40 patients across two locations to be enrolled."
Answered by AI
What other experiments have been undertaken to evaluate Varenicline?
"Currently, 113 studies on Varenicline are ongoing - 17 of which are Phase 3 trials. Most of these experiments take place in Charleston, South carolina although there are 530 sites worldwide conducting related research."
Answered by AI
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