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Behavioral Intervention
Smoking Cessation Counseling + Pharmacotherapy for Smoking Cessation
Phase < 1
Waitlist Available
Led By Paul Cinciripini, PHD, MS, BS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 50 or older
Be older than 18 years old
Must not have
Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Unwilling to refrain from other nicotine substitutes use (i.e., OTC or prescription medication for smoking cessation) or smoking cessation treatments during the course of the active treatment portion of the study other than what is provided to or recommended for use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial is for smokers who want to change their smoking behaviors and will offer counseling and potentially FDA approved smoking cessation drugs.
Who is the study for?
This trial is for smokers over 50 who want to quit and are eligible for lung cancer screening. They must be able to follow instructions in English, not be using other cessation programs or products, and agree to counseling and potential pharmacotherapy. Pregnant women or those on certain medications are excluded.Check my eligibility
What is being tested?
The study tests different smoking cessation counseling methods plus the option of FDA-approved drugs like Nicotine Patches or anti-smoking medication. Participants will also receive a low-dose CT scan as part of lung cancer screening at MD Anderson.See study design
What are the potential side effects?
Possible side effects from the smoking cessation drugs may include skin irritation from patches, sleep problems, mood changes, increased heart rate, mouth issues with lozenges/gum, and nausea. Individual experiences with these side effects can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.
Select...
I agree not to use any smoking cessation aids other than those provided by the study.
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
Smoking Abstinence Rate
Trial Design
3Treatment groups
Experimental Treatment
Group I: Quitline-Rx (QL-Rx) GroupExperimental Treatment8 Interventions
Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider.
LDCT provider and patient discuss options for pharmacotherapy.
Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Group II: Quitline (QL) GroupExperimental Treatment7 Interventions
Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. Participants given shared decision making and discussion about screening with the LDCT provider.
Participants referred to the Quitline for counseling and NRT (nicotine patch). Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Group III: Integrated Care (IC) GroupExperimental Treatment8 Interventions
Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider.
Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quitline
2011
N/A
~820
Cessation Counseling
2014
N/A
~530
Nicotine
FDA approved
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,793,649 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,771 Total Patients Enrolled
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 50 years old or older.I have smoked in the last 30 days and am open to treatments that could help me quit.I am medically cleared to use medications to help me stop smoking.You have an address and telephone number where he/she may be reached.I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.I am willing and can have a low dose CT scan for lung cancer screening.You use tobacco products other than cigarettes or little cigars, like cigars, chewing tobacco, snuff, pipes, or e-cigarettes.I have smoked in the last 30 days and am open to treatments that could help me quit.I am currently using medication to help me quit smoking.I agree not to use any smoking cessation aids other than those provided by the study.I am willing and able to have a low dose CT scan for lung cancer screening.
Research Study Groups:
This trial has the following groups:- Group 1: Quitline (QL) Group
- Group 2: Quitline-Rx (QL-Rx) Group
- Group 3: Integrated Care (IC) Group
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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.
Smoking Cessation Patient Testimony for trial: Trial Name: NCT03059940 — Phase < 1
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