Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Carbon Monoxide; Nicotine

Criteria

Inclusion Criteria:

1. Age: 50 or older

2. 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.

3. Meets guidelines for lung cancer screening, as determined by radiology team

4. Able to follow verbal and written instructions in English and complete all aspects of the study.

5. Provide informed consent and agree to all assessments and study procedures.

6. Have an address and telephone number where he/she may be reached.

7. Be the only participant in his/her household on active treatment in Protocol 2016-0626 at the time.

8. Following good clinical practice guidelines, be medically suitable for one or more pharmacotherapies for smoking cessation including NRT, bupropion or varenicline, at provider discretion.

9. 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.

Exclusion Criteria:

1. Current enrollment or plans to enroll in another smoking cessation program in the next 9 months.

2. Unwilling to refrain from other nicotine substitutes (i.e., OTC or prescription medication for smoking cessation) or smoking cessation treatments in the next 9 months.

3. Current use of certain medications: (1) Smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, NRT, Chantix.

4. A positive urine pregnancy test during the screening period. Women who are one year post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test.

5. Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study. 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.

6. Exclusive use of tobacco products other than cigarettes, such as (but not limited to) cigars, chew, snuff, pipe or e-cigs.