Cigarette Smoker Clinical Trial
Official title:
The Effects of a Standardized Research E-Cigarette on the Human Lung: A Clinical Trial With Bronchoscopic Biomarkers
This trial studies biomarkers obtained by bronchoscopy (bronchoalveolar lavage and lung brushings) to determine the effect of smoking e-cigarettes on the lungs. Studying samples of lung cells from participants who smoke e-cigarettes may help doctors learn more about changes that occur in deoxyribonucleic acid and identify biomarkers related to cancer.
PRIMARY OBJECTIVES: I. To assess inflammatory changes over 10 weeks for lung and urine biomarkers in smokers who undergo serial bronchoscopy. The randomized trial includes four conditions: continued use (n=32), complete switching to the nicotine standardized research electronic cigarettes (e-cig) (SREC) (n=32), complete switching to the placebo (nicotine free) SREC (n=32), and complete switching to nicotine replacement therapy (NRT)(n=32). OUTLINE: Participants are randomized to 1 of 4 groups. GROUP I: Participants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71. GROUP II: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71. GROUP III: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71. GROUP IV: Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71. After completion of study, participants are followed up at 3 months. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01967082 -
APPSPIRE App in Preventing Students From Smoking
|
N/A | |
Recruiting |
NCT03865472 -
rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers
|
N/A | |
Active, not recruiting |
NCT02271919 -
Varenicline and Combined NRT for Smoking Cessation
|
Phase 4 | |
Withdrawn |
NCT03668769 -
Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking
|
N/A | |
Completed |
NCT02575885 -
Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers
|
N/A | |
Completed |
NCT04060446 -
Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers
|
||
Completed |
NCT00941395 -
Enhanced Smoking Cessation for University Students
|
N/A | |
Recruiting |
NCT03199651 -
Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer
|
N/A | |
Recruiting |
NCT03824535 -
18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules
|
Phase 2 | |
Completed |
NCT00468234 -
Validation of Biomarkers of Exposure and Host Response
|
N/A | |
Completed |
NCT00850954 -
Project CASA in Promoting Smoke-Free Indoor Air Policy in Mexican American Households
|
N/A | |
Active, not recruiting |
NCT02697227 -
Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation
|
N/A | |
Completed |
NCT03669120 -
Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking
|
N/A | |
Completed |
NCT00948129 -
Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers
|
N/A |