Smoking Cessation Counseling + Pharmacotherapy for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Overseen byPaul Cinciripini

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to offer lung cancer screenings to smokers who want to change their smoking behaviors. All eligible participants will receive smoking cessation counseling and may be offered at least one form of smoking cessation drug. Different forms of counseling (the delivery of counseling and access to counseling) will be compared. This is an investigational study. Participants on this study will not be prescribed smoking drugs directly by the study staff. However, participants in this study may or may not receive smoking cessation drugs, depending on what the provider thinks is in the participants best interest. All smoking cessation drugs being used are FDA approved and commercially available. It is investigational to compare the different forms of counseling participants receive. Up to 1260 participants will be enrolled in this study. All will take part at MD Anderson.

Research Team

Paul Cinciripini

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion 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.

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Exclusion Criteria

I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.

You use tobacco products other than cigarettes or little cigars, like cigars, chewing tobacco, snuff, pipes, or e-cigarettes.

Current enrollment or plans to enroll in another smoking cessation program in the next 6 months

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Treatment Details

Interventions

Anti-Smoking Drug (Drug)
Cessation Counseling (Behavioral Intervention)
Nicotine Patch (Drug)
Shared Decision Making + Video (Other)

Trial OverviewThe 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.

Participant Groups

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,