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Procedure
E-Cigarettes for Smokers at High Risk for Lung Cancer
N/A
Recruiting
Led By Jason Robinson, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meeting 2021 USPSTF lung cancer screening guidelines (adults aged 50-80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years)
Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days)
Must not have
Evidence of cognitive deficits or instability that would preclude reliable study participation
Have ever had a diagnosis of lung cancer, have uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Summary
This trial investigates whether switching from regular cigarettes to e-cigarettes is harmful or helpful for older smokers at high risk for lung cancer. The results may help inform the FDA's regulation of e-cigarettes.
Who is the study for?
This trial is for older adult smokers aged 50-80 with a significant smoking history who are at high risk for lung cancer and interested in trying electronic cigarettes (e-cigarettes) to change their smoking habits. They must speak and write English, be able to receive mail, comply with COVID-19 policies, and agree to biospecimen collection. Pregnant women or those not using effective birth control are excluded.
What is being tested?
The study compares the health effects of continuing traditional cigarette smoking versus switching to e-cigarettes over a period of 26 weeks. Participants will also complete questionnaires and may use nicotine replacement therapies. The goal is to inform FDA regulations on e-cigarettes.
What are the potential side effects?
Potential side effects from using e-cigarettes could include irritation of the mouth or throat, coughing, nausea, headache, heart palpitations, muscle aches or sleep disturbances. Nicotine replacement can cause similar symptoms along with skin irritation if patches are used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50-80 years old and have a significant smoking history.
Select...
I have smoked at least once in the past 30 days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any cognitive issues that would stop me from reliably participating in the study.
Select...
I have lung cancer and a medical condition that is not well-managed.
Select...
I have severe depression or thoughts of harming myself, as shown by my PHQ-9 score.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cigarettes per day
Secondary study objectives
8-epi prostaglandin F2 alpha (8-epi-PGF2a)
High-sensitivity C-reactive protein (hs-CRP)
White blood cells (WBC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: E-CigarettesExperimental Treatment4 Interventions
Participants vape 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 182 days. Participants complete questionnaires over 50 minutes and undergo collection of urine sample at 0, 1, 7, 13, and 27 weeks, and collection of blood samples at 6, 12, and 26 weeks. Participants may also undergo measurement of CO levels at 1, 6, 12, and 26 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Replacement
2019
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,561 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,860 Total Patients Enrolled
Jason Robinson, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any cognitive issues that would stop me from reliably participating in the study.I am not pregnant, breastfeeding, or at risk of becoming pregnant because I use effective birth control.I have lung cancer and a medical condition that is not well-managed.I have severe depression or thoughts of harming myself, as shown by my PHQ-9 score.I am between 50-80 years old and have a significant smoking history.I cannot or will not visit the clinic for samples or to get study products.I agree not to be in a vehicle during study procedures or when talking to study staff.Wanting to use e-cigarettes to quit regular cigarette smoking.I have smoked at least once in the past 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: E-Cigarettes
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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