Smoking CessationEarly Phase 1NCT03059940
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
A Early Phase 1 study testing Questionnaires, Low Dose Computed Tomography Scan and Shared Decision Making + Video in people with Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Questionnaires, Low Dose Computed Tomography Scan and Shared Decision Making + Video
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2017to 15 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Optimizing Effectiveness of Smoking Cessation Intervention During Low Dose CT Screening for Lung Cancer
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.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will have a CT scan of your chest to look for signs of lung cancer. You will receive the results 0-4 days after the scan. If there are any abnormal areas, you will be referred to your regular doctor for follow-up. No matter what the results are, you will be advised to quit smoking. If you have previously had a low dose CT scan for lung cancer screening in the last 30 days, you may still be eligible to participate in this study. You will be asked to provide documentation of the CT scan results.
You will receive a referral for counseling to help you reduce/quit smoking. You may also discuss medications you can take to reduce smoking.
As part of your counseling treatment, you may be prescribed an FDA-approved and commercially available anti-smoking drug. This may be either nicotine replacement therapy (such as a patch, gum, or lozenge) or an oral drug (such as varenicline or buproprion). The provider will tell you when and how much of your anti-smoking drug you should take each time, based on a discussion between you and your provider. Receiving anti-smoking medication will be done through your counseling treatment and not as part of your participation in this study.
You will have at least 5, but no more than 8, smoking cessation counseling sessions over the next 12 weeks. Each session will last between 30 - 60 minutes, in which you will set a quit date, prepare for your quit date, and discuss coping skills for dealing with smoking "triggers" after your quit date. You will also discuss challenges you may have with quitting.
Study Visits:
You will have 3 additional study visits, at around 6 weeks, 12 weeks, and 6 months after the screening visit, as well as 1 follow-up phone call. At all study visits:
- You will complete questionnaires about several topics, including depression, suicide, and your smoking behavior. These questionnaires should take about 30-45 minutes in total to complete.
- Your CO level will be measured.
- Urine and/or saliva may be collected (at 12 weeks and 6 months only) for a routine test to check your cotinine and nicotine. Cotinine is a chemical released in your body when it breaks down nicotine and will show whether and how much you have recently smoked.
Follow-Up:
About 5 months after you start receiving counseling sessions, you will be called by a member of the study staff and asked about your recent smoking behaviors and habits. This call should last about 5-10 minutes.
- Conditions
- Smoking Cessation
- Being tested
- Questionnaires, Low Dose Computed Tomography Scan, Shared Decision Making + Video, Cessation Counseling, Quitline
- Keywords
- Smoking Cessation, Low Dose computed tomography, LDCT, Quitline, Questionnaires, Surveys, Counseling, Smoking cessation drugs, Anti-Smoking Drug, Nicotine replacement therapy, NRT, Nicotine Patch
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Low Dose Computed Tomography ScanProcedure or surgery
Also called LDCT
Participants have a CT scan of chest to look for signs of lung cancer.
Shared Decision Making + VideoOther
Participants given shared decision making and discussion about screening with the LDCT provider. Participants watch a short video about lung cancer, CT scans, and smoking cessation.
Cessation CounselingBehavioural
Brief cessation counseling given by LDCT provider.
QuitlineBehavioural
Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Pharmacotherapy DiscussionBehavioural
Participant informed of the risk, benefits and relative efficacy of cessation medications and to assess their medication preferences, expectations and medical suitability for either option. At the conclusion of this conversation the patient is provided with an initial supply of the medication jointly decided between provider and patient.
Nicotine PatchDrug
Nicotine patch dispensed. Dosing at physician's discretion.
Anti-Smoking DrugDrug
Varenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.
Tobacco Treatment ProgramBehavioural
Also called TTP
Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,
Carbon Monoxide (CO) Level TestOther
Also called CO
Participant asked to blow air through a CO-measuring device.
| Study group | Role | What they receive |
|---|---|---|
| Quitline (QL) Group | Experimental | 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. Receives: 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 |
| Quitline-Rx (QL-Rx) Group | Experimental | 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. Receives: Behavioral: Questionnaires; Procedure: Low Dose Computed Tomography Scan; Other: Shared Decision Making + Video; Behavioral: Cessation Counseling; Behavioral: Quitline; Behavioral: Pharmacotherapy Discussion; Drug: Anti-Smoking Drug; Other: Carbon Monoxide (CO) Level Test |
| Integrated Care (IC) Group | Experimental | 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, Receives: Behavioral: Questionnaires; Procedure: Low Dose Computed Tomography Scan; Other: Shared Decision Making + Video; Behavioral: Cessation Counseling; Behavioral: Pharmacotherapy Discussion; Drug: Anti-Smoking Drug; Behavioral: Tobacco Treatment Program; Other: Carbon Monoxide (CO) Level Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence Rate
Statistical power will focus on primary objective. Primary analyses use intention-to-treat (ITT) principles, with missing observations imputed as smoking.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start16 Jun 2017
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Responsible party
- Sponsor
- Investigators
- Jason D Robinson, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059940
- Sponsor's protocol ID
- 2016-0626
- Other IDs
- R01-CA 2027078-01, NCI-2018-01219
- Status last verified
- Oct 2026
- First submitted
- 17 Feb 2017
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cinciripini 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.
PubMed 39804633
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Effectiveness of Smoking Cessation Intervention During Low Dose CT Screening for Lung Cancer
- ClinicalTrials.gov ID
- NCT03059940
- Acronym / sponsor ID
- 2016-0626
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Low Dose computed tomography, LDCT, Quitline, Questionnaires, Surveys, Counseling, Smoking cessation drugs
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 630 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will have a CT scan of your chest to look for signs of lung cancer. You will receive the results 0-4 days after the scan. If there are any abnormal areas, you will be referred to your regular doctor for follow-up. No matter what the results are, you will be advised to quit smoking. If you have previously had a low dose CT scan for lung cancer screening in the last 30 days, you may still be eligible to participate in this study. You will be asked to provide documentation of the CT scan results.
You will receive a referral for counseling to help you reduce/quit smoking. You may also discuss medications you can take to reduce smoking.
As part of your counseling treatment, you may be prescribed an FDA-approved and commercially available anti-smoking drug. This may be either nicotine replacement therapy (such as a patch, gum, or lozenge) or an oral drug (such as varenicline or buproprion). The provider will tell you when and how much of your anti-smoking drug you should take each time, based on a discussion between you and your provider. Receiving anti-smoking medication will be done through your counseling treatment and not as part of your participation in this study.
You will have at least 5, but no more than 8, smoking cessation counseling sessions over the next 12 weeks. Each session will last between 30 - 60 minutes, in which you will set a quit date, prepare for your quit date, and discuss coping skills for dealing with smoking "triggers" after your quit date. You will also discuss challenges you may have with quitting.
Study Visits:
You will have 3 additional study visits, at around 6 weeks, 12 weeks, and 6 months after the screening visit, as well as 1 follow-up phone call. At all study visits:
- You will complete questionnaires about several topics, including depression, suicide, and your smoking behavior. These questionnaires should take about 30-45 minutes in total to complete.
- Your CO level will be measured.
- Urine and/or saliva may be collected (at 12 weeks and 6 months only) for a routine test to check your cotinine and nicotine. Cotinine is a chemical released in your body when it breaks down nicotine and will show whether and how much you have recently smoked.
Follow-Up:
About 5 months after you start receiving counseling sessions, you will be called by a member of the study staff and asked about your recent smoking behaviors and habits. This call should last about 5-10 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quitline (QL) Group | Experimental | 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 TestQuestionnaires 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. |
| Quitline-Rx (QL-Rx) Group | Experimental | Behavioral: Questionnaires, Procedure: Low Dose Computed Tomography Scan, Other: Shared Decision Making + Video, Behavioral: Cessation Counseling, Behavioral: Quitline, Behavioral: Pharmacotherapy Discussion, Drug: Anti-Smoking Drug, Other: Carbon Monoxide (CO) Level TestQuestionnaires 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. |
| Integrated Care (IC) Group | Experimental | Behavioral: Questionnaires, Procedure: Low Dose Computed Tomography Scan, Other: Shared Decision Making + Video, Behavioral: Cessation Counseling, Behavioral: Pharmacotherapy Discussion, Drug: Anti-Smoking Drug, Behavioral: Tobacco Treatment Program, Other: Carbon Monoxide (CO) Level TestQuestionnaires 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, |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. | Behavioural | Integrated Care (IC) Group, Quitline (QL) Group, Quitline-Rx (QL-Rx) Group |
| Low Dose Computed Tomography ScanAlso: LDCTParticipants have a CT scan of chest to look for signs of lung cancer. | Procedure or surgery | Integrated Care (IC) Group, Quitline (QL) Group, Quitline-Rx (QL-Rx) Group |
| Shared Decision Making + VideoParticipants given shared decision making and discussion about screening with the LDCT provider. Participants watch a short video about lung cancer, CT scans, and smoking cessation. | Other | Integrated Care (IC) Group, Quitline (QL) Group, Quitline-Rx (QL-Rx) Group |
| Cessation CounselingBrief cessation counseling given by LDCT provider. | Behavioural | Integrated Care (IC) Group, Quitline (QL) Group, Quitline-Rx (QL-Rx) Group |
| QuitlineParticipants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks. | Behavioural | Quitline (QL) Group, Quitline-Rx (QL-Rx) Group |
| Pharmacotherapy DiscussionParticipant informed of the risk, benefits and relative efficacy of cessation medications and to assess their medication preferences, expectations and medical suitability for either option. At the conclusion of this conversation the patient is provided with an initial supply of the medication jointly decided between provider and patient. | Behavioural | Integrated Care (IC) Group, Quitline-Rx (QL-Rx) Group |
| Nicotine PatchNicotine patch dispensed. Dosing at physician's discretion. | Drug | Quitline (QL) Group |
| Anti-Smoking DrugVarenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time. | Drug | Integrated Care (IC) Group, Quitline-Rx (QL-Rx) Group |
| Tobacco Treatment ProgramAlso: TTPParticipant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period, | Behavioural | Integrated Care (IC) Group |
| Carbon Monoxide (CO) Level TestAlso: COParticipant asked to blow air through a CO-measuring device. | Other | Integrated Care (IC) Group, Quitline (QL) Group, Quitline-Rx (QL-Rx) Group |
Primary outcome
Smoking Abstinence Rate
Time frame: 6 months
Statistical power will focus on primary objective. Primary analyses use intention-to-treat (ITT) principles, with missing observations imputed as smoking.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 39804633Cinciripini 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.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason D Robinson, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Questionnaires, Low Dose Computed Tomography Scan and Shared Decision Making + Video in people with Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Abstinence Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.