Clinical trial · Interventional
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Optimizing Effectiveness of Smoking Cessation Intervention During Low Dose CT Screening for Lung Cancer
NCT03059940CI-TRIAL-00108304active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smoking Cessation | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-Smoking Drug | Drug | — | UNRESOLVED |
| Carbon Monoxide (CO) Level Test | Other | — | UNRESOLVED |
| Cessation Counseling | Behavioral | — | UNRESOLVED |
| Low Dose Computed Tomography Scan | Procedure | — | UNRESOLVED |
| Nicotine Patch | Drug | — | UNRESOLVED |
| Pharmacotherapy Discussion | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Quitline | Behavioral | — | UNRESOLVED |
| Shared Decision Making + Video |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Quitline (QL) Group
- description
- 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.
- interventionNames
- Behavioral: Questionnaires
- Procedure: Low Dose Computed Tomography Scan
- Other: Shared Decision Making + Video
- Behavioral: Cessation Counseling
- Behavioral: Quitline
- Drug: Nicotine Patch
- Other: Carbon Monoxide (CO) Level Test
- type
- EXPERIMENTAL
- label
- Quitline-Rx (QL-Rx) Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 50 or older * Meets guidelines for lung cancer screening, as determined by radiology team * Reports being a daily or non-daily smoker (any self-reported smoking in the past 30days) and is interested in treatment that might change smoking behavior. * Able to follow verbal and written instructions in English and complete all aspects ofthe study. * Provide informed consent and agree to all assessments and study procedures. * Have an address where he/she can receive mail * If opting to participate in telemedicine visits, must have a device available to conduct telehealth visits (e.g., smartphone, computer, tablet, etc.). * Be the only participant in his/her household on active treatment in Protocol 2016-0626at the time. * Willing and able to undergo low dose CT scan, as determined by radiology team, and has either had a lung cancer screen within 30 days prior to enrollment into this protocol or schedules a LDCT scan for lung cancer screening to occur while taking part in the 2016-0626 protocol. Exclusion Criteria: * Current enrollment or plans to enroll in another smoking cessation program in the next6 months. * Unwilling to refrain from other nicotine substitutes use (i.e., OTC orprescription medication for smoking cessation) or smoking cessation treatments during the course of the the active treatment portion of the study other than what is provided to or recommended for use. * Current use of certain medications: (1) Smoking cessation meds (last 7 days), that are being used as part of a current attempt to quit smoking i.e., Wellbutrin, Bupropion, Zyban, NRT, Chantix. * 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 asbirth control pills, patches, implants or injections), (2) barrier methods (such as a condomor diaphragm) used with a spermicide, or (3) an intrauterine device (IUD).Contraceptive measures sold for emergency use after unprotected sex are not acceptable methodsfor routine use. * Exclusive use of tobacco products other than cigarettes or little cigars, such as (but not limited to) cigars, chew, snuff, pipe or e-cigs. * Individuals who are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or study physician
References
Publications (1)
- DERIVEDCinciripini PM, Minnix JA, Kypriotakis G, Erasmus J, Beneventi D, Karam-Hage M, Carpenter K, Volk RJ, Carter B, Godoy MCB, Strange C, Shih YT, Cui Y, Green CE, Robinson JD. Smoking Cessation Interventions in the Lung Cancer Screening Setting: A Randomized Clinical Trial. JAMA Intern Med. 2025 Mar 1;185(3):284-291. doi: 10.1001/jamainternmed.2024.7288. PMID 39804633