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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
Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days) and is interested in treatment that might change smoking behavior.
Willing and able to undergo low dose CT scan, as determined by radiology team,or has had a lung cancer screen within 30 days of enrollment into this protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Study 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 below
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I have smoked in the last 30 days and am open to treatments that could help me quit.
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I am willing and able to have a low dose CT scan for lung cancer screening.
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I have smoked in the last 30 days and am open to treatments that could help me quit.
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I am willing and can have a low dose CT scan for lung cancer screening.
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I am medically cleared to use medications to help me stop smoking.
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I am 50 years old or older.
Select...
I am 50 years old or older.

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
Smoking Abstinence Rate

Awards & Highlights

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.

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
Cessation Counseling
2014
N/A
~530
Quitline
2011
N/A
~820
Nicotine
FDA approved
Questionnaires
2013
Completed Phase 2
~3030

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,944 Previous Clinical Trials
1,774,751 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,577 Previous Clinical Trials
41,223,770 Total Patients Enrolled
PfizerIndustry Sponsor
4,544 Previous Clinical Trials
11,422,278 Total Patients Enrolled

Media Library

Cessation Counseling (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03059940 — Phase < 1
Smoking Cessation Research Study Groups: Quitline-Rx (QL-Rx) Group, Quitline (QL) Group, Integrated Care (IC) Group
Smoking Cessation Clinical Trial 2023: Cessation Counseling Highlights & Side Effects. Trial Name: NCT03059940 — Phase < 1
Cessation Counseling (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03059940 — Phase < 1
Smoking Cessation Patient Testimony for trial: Trial Name: NCT03059940 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are participating in the clinical trial?

"Unfortunately, this research is not looking for participants at the moment. Specifically, it was first posted on June 16th 2017 and most recently updated August 15th 2022. If you're interested in other studies there are 142 trials dedicated to smoking cessation and 71 questionnaires actively enrolling patients."

Answered by AI

Is there evidence to suggest that Questionnaires have been employed in other scientific research?

"At the current moment, 71 research studies exploring Questionnaires are being conducted. Of these active trials, 5 of them have progressed to Phase 3. Conducting their investigations mostly from Green Bay, Wisconsin, there is a total of 204 locations running clinical trial for this experimental therapy."

Answered by AI

Are there still vacancies for this clinical experiment?

"This clinical trial is not presently seeking participants, given the information available on clinicaltrials.gov. This study was first posted in June 2017 and last edited in August 2022; however, there are 213 other trials actively searching for patients right now."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Helping develop new and improved coping strategies and medications for addictive health.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Texas MD Anderson Cancer Center: < 48 hours
Average response time
  • < 2 Days
~23 spots leftby Jun 2024