Lung CarcinomaNCT05144542
Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
A study testing Nicotine Replacement in people with Lung Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial investigates the effects of switching from smoking regular cigarettes to electronic cigarettes (e-cigarettes) among older adult smokers at high risk for lung cancer. E-cigarettes use heated vapor to deliver nicotine. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Nicotine Replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 17 Oct 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50-80 years who currently smokes at least 1 or more combustible cigarettes per day OR who is a nondaily smoker (any self-reported smoking in the past 30 days) with a 20 pack-year history.
- Being interested in trying ECs to change CC smoking behavior
- Willing to have biospecimen samples taken, either in-home using a mobile phlebotomoty service, or at an approved collection site
- Have an address where he/she can receive mail
- Being fluent in spoken and written English
- Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit.
- The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle.
Who cannot join
- Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above); or who report current suicidal ideation on the PHQ-9
- Have ever had a diagnosis of lung cancer, have uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes)
- Unwilling to consent for blood draw
- Evidence of cognitive deficits or instability that would preclude reliable study participation
- 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 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.
- Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situations: unwilling or unable to comply with study procedures)
- Individuals who reside in an area that is outside of our shipping company or mobile phlebotomty contractors' areas of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline to come in to clinic to provide necessary samples and/or collect study products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Risks and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
This clinical trial investigates the effects of switching from smoking regular cigarettes to electronic cigarettes (e-cigarettes) among older adult smokers at high risk for lung cancer. E-cigarettes use heated vapor to deliver nicotine. Information gained from this trial may help inform regulators of the potential risks and benefits of switching smokers at high risk for lung cancer to electronic cigarettes. This research also may help inform the Food and Drug Administration (FDA) how best to regulate e-cigarettes with the goal of improving public health.
Read the detailed description
PRIMARY OBJECTIVE:
- To characterize the effects of switching from combustible cigarettes (CCs) to e-cigarettes (ECs) on product use, product acceptability, and reinforcement among adult daily CC smokers at high risk for lung cancer.
EXPLORATORY OBJECTIVES:
- To characterize the effects of switching from CCs to ECs on biomarkers of inflammation and oxidative stress among adult daily CC smokers at high for lung cancer.
II. To characterize metabolomic changes that result from switching from CCs to ECs among CC smokers at high risk for lung cancer
III. To characterize which factors moderate or mediate the effects of switching from CCs to ECs among CC smokers at high risk for lung cancer
OUTLINE:
Participants are assigned to switch to e-cigarettes.
Participants vape study-provided e-cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood and log daily smoking activity every day for up to 26 weeks. Participants complete questionnaires over 30-45 minutes and undergo collection of urine and blood samples on study.
- Conditions
- Lung Carcinoma
- Being tested
- Nicotine Replacement
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine ReplacementDrug
Also called Nicotine Replacement Therapy, NRT
Vape e-cigarettes
| Study group | Role | What they receive |
|---|---|---|
| E-Cigarettes | Experimental | Participants vape study-provided e-cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood and log daily smoking activity every day for up to 26 weeks. Participants complete questionnaires over 30-45 minutes and undergo collection of urine and blood samples on study. Receives: Drug: Nicotine Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combustible Cigarettes Per Day
Mean cigarettes per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)
Measured: Study Week 1 and Week 27
Secondary outcomes (3)
Electronic Cigarette Sessions Per Day
Mean electronic cigarette sessions per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)
Measured: Study Week 27
Anabasine
Geometric means of the natural log of urine anabasine levels collected at study week 1 (end of combustible cigarette smoking baseline) and week 27 (end of electronic cigarette provision).
Measured: Study Week 1 and Week 27
Fagerström Test for Cigarette Dependence
The Fagerström Test for Cigarette Dependence (FTCD) is a measure of cigarette dependence. Scores range from 0 to 10, with higher scores indicating greater dependence.
Measured: Study Week 1 and Week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start7 Mar 2022
- Primary completion17 Oct 2025
- Study completion17 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CarcinomaStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jason Robinson, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144542
- Sponsor's protocol ID
- 2019-1266
- Other IDs
- NCI-2021-03212, 2019-1266, R01CA238478
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2021
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Risks and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
- ClinicalTrials.gov ID
- NCT05144542
- Acronym / sponsor ID
- 2019-1266
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2026 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Posted 5 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial investigates the effects of switching from smoking regular cigarettes to electronic cigarettes (e-cigarettes) among older adult smokers at high risk for lung cancer. E-cigarettes use heated vapor to deliver nicotine. Information gained from this trial may help inform regulators of the potential risks and benefits of switching smokers at high risk for lung cancer to electronic cigarettes. This research also may help inform the Food and Drug Administration (FDA) how best to regulate e-cigarettes with the goal of improving public health.
Detailed description
PRIMARY OBJECTIVE:
- To characterize the effects of switching from combustible cigarettes (CCs) to e-cigarettes (ECs) on product use, product acceptability, and reinforcement among adult daily CC smokers at high risk for lung cancer.
EXPLORATORY OBJECTIVES:
- To characterize the effects of switching from CCs to ECs on biomarkers of inflammation and oxidative stress among adult daily CC smokers at high for lung cancer.
II. To characterize metabolomic changes that result from switching from CCs to ECs among CC smokers at high risk for lung cancer
III. To characterize which factors moderate or mediate the effects of switching from CCs to ECs among CC smokers at high risk for lung cancer
OUTLINE:
Participants are assigned to switch to e-cigarettes.
Participants vape study-provided e-cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood and log daily smoking activity every day for up to 26 weeks. Participants complete questionnaires over 30-45 minutes and undergo collection of urine and blood samples on study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-Cigarettes | Experimental | Drug: Nicotine ReplacementParticipants vape study-provided e-cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood and log daily smoking activity every day for up to 26 weeks. Participants complete questionnaires over 30-45 minutes and undergo collection of urine and blood samples on study. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 50-80 years who currently smokes at least 1 or more combustible cigarettes per day OR who is a nondaily smoker (any self-reported smoking in the past 30 days) with a 20 pack-year history.
- Being interested in trying ECs to change CC smoking behavior
- Willing to have biospecimen samples taken, either in-home using a mobile phlebotomoty service, or at an approved collection site
- Have an address where he/she can receive mail
- Being fluent in spoken and written English
Key exclusion criteria (7 listed)
- Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above); or who report current suicidal ideation on the PHQ-9
- Have ever had a diagnosis of lung cancer, have uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes)
- Unwilling to consent for blood draw
- Evidence of cognitive deficits or instability that would preclude reliable study participation
- 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 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.
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 |
|---|---|---|
| Nicotine ReplacementAlso: Nicotine Replacement Therapy, NRTVape e-cigarettes | Drug | E-Cigarettes |
Primary outcome
Combustible Cigarettes Per Day
Time frame: Study Week 1 and Week 27
Mean cigarettes per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)
3 secondary outcomes
Electronic Cigarette Sessions Per Day
Time frame: Study Week 27
Anabasine
Time frame: Study Week 1 and Week 27
Fagerström Test for Cigarette Dependence
Time frame: Study Week 1 and Week 27
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Lung Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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 Robinson, PHD 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 study testing Nicotine Replacement in people with Lung Carcinoma, 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 7 inclusion and 7 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 5 Aug 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Combustible Cigarettes Per Day (time frame: Study Week 1 and Week 27). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.