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Bronchoscopy to Study E-Cigarette Effects in Cigarette Smokers

Phase < 1
Recruiting
Led By Peter Shields, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 71
Awards & highlights

Study Summary

This trial is studying how smoking e-cigarettes affects the lungs by looking at changes in the DNA of lung cells.

Who is the study for?
This trial is for everyday smokers who have smoked at least 5 cigarettes a day for over a year, can read and consent to study procedures, and are in stable health. It's not for those with recent lung issues or procedures, pregnant/breastfeeding women, users of inhalants or antibiotics within specific timeframes, those allergic to certain substances like propylene glycol/glycerin or flavors, heavy marijuana users, individuals with kidney/liver disease or immune disorders.Check my eligibility
What is being tested?
The trial is using bronchoscopy to collect lung cell samples from e-cigarette smokers to find biomarkers related to cancer. Participants will undergo bronchoalveolar lavage and brushings while also providing information through questionnaires about their smoking habits.See study design
What are the potential side effects?
Potential side effects include discomfort from the bronchoscopy procedure such as sore throat or coughing. There may be risks associated with sedation used during the procedure (like lidocaine), including allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 71
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 71 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Secondary outcome measures
Changes in deoxyribonucleic acid (DNA) gene methylation
Changes in fractional exhaled nitric oxide (FeNO) levels
Changes in messenger (m) ribonucleic acid (RNA) and microRNA (miRNA) gene expression analyzed using sequencing
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group IV (Nicotine Replacement Therapy [NRT])Experimental Treatment4 Interventions
Participants undergo bronchoscopy over 30-60 minutes at baseline. One 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.
Group II: Group III (SREC without nicotine)Experimental Treatment4 Interventions
Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week after 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 III: Group II (SREC with nicotine)Experimental Treatment4 Interventions
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 starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71.
Group IV: Group I (usual cigarette brand)Active Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,501 Previous Clinical Trials
2,624,853 Total Patients Enrolled
2 Trials studying Cigarette Smokers
66 Patients Enrolled for Cigarette Smokers
Ohio State University Comprehensive Cancer CenterLead Sponsor
325 Previous Clinical Trials
290,365 Total Patients Enrolled
1 Trials studying Cigarette Smokers
2,994 Patients Enrolled for Cigarette Smokers
Peter Shields, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
3,136 Total Patients Enrolled
1 Trials studying Cigarette Smokers
2,994 Patients Enrolled for Cigarette Smokers

Media Library

Bronchoscopy with Bronchoalveolar Lavage Clinical Trial Eligibility Overview. Trial Name: NCT03691350 — Phase < 1
Cigarette Smokers Research Study Groups: Group IV (Nicotine Replacement Therapy [NRT]), Group I (usual cigarette brand), Group II (SREC with nicotine), Group III (SREC without nicotine)
Cigarette Smokers Clinical Trial 2023: Bronchoscopy with Bronchoalveolar Lavage Highlights & Side Effects. Trial Name: NCT03691350 — Phase < 1
Bronchoscopy with Bronchoalveolar Lavage 2023 Treatment Timeline for Medical Study. Trial Name: NCT03691350 — Phase < 1
~35 spots leftby Jun 2025