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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I am between 50-80 years old and have a significant smoking history.
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I have smoked at least once in the past 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cigarettes per day
Secondary outcome measures
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
2,973 Previous Clinical Trials
1,789,181 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,765 Total Patients Enrolled
Jason Robinson, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Participants smoke their usual brand of cigarettes for 26 weeks. (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05144542 — N/A
Lung Cancer Research Study Groups: E-Cigarettes
Lung Cancer Clinical Trial 2023: Participants smoke their usual brand of cigarettes for 26 weeks. Highlights & Side Effects. Trial Name: NCT05144542 — N/A
Participants smoke their usual brand of cigarettes for 26 weeks. (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144542 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What previous experiments have examined the long-term impacts of vaping?

"As of now, 71 ongoing trials are researching the effects Participants will vape electronic cigarettes for 26 weeks., with 5 currently in Phase 3. Primarily based out of Greenville, South carolina, there are 204 locations across the United States conducting studies regarding Participants will vape electronic cigarettes for 26 weeks.."

Answered by AI

How many individuals are being observed in this investigation?

"Affirmative. Clinicaltrials.gov records demonstrate that recruitment for this medical trial is currently ongoing, having been first posted on 7th March 2022 and most recently revised 19th October 2022. The research requires 330 persons to enroll at a single facility."

Answered by AI

Are there vacancies in this trial that individuals can participate in?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, initiated on March 7th 2022, is currently looking for participants. 330 candidates are required to be recruited from a single clinical site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
2022. "Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05144542.
~45 spots leftby Apr 2025
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