The Potential Risks and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Jason Robinson, PHD
nicotinestudy@mdanderson.org
713-792-2265
Time Frame
Start Date: 2022-03-07
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 140
Treatments
Experimental: E-Cigarettes
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov