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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 71
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 71
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 moreTrial 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
2,503 Previous Clinical Trials
2,625,344 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had bronchitis or pneumonia in the past year.You have had general anesthesia within the past year.You smoke at least 5 cigarettes with filters per day for at least 1 year.You have been using inhaler medications regularly in the past 2 months.You have taken antibiotics in the last 30 days.You are allergic to propylene glycol, glycerin, or any flavors used in the study.You regularly smoke cigarettes that you make yourself.You have a medical condition that could make it risky to perform a bronchoscopy, affect the accuracy of biomarker data, or increase the chances of experiencing negative effects from using an e-cigarette.You have had a bad allergic reaction to varenicline in the past.You have used e-cigarettes or other tobacco products that you burn and inhale in the past 3 months.You had a bad reaction when using an e-cigarette before.Your weight is very high, which can make it difficult to manage your breathing during the study.You have been using marijuana regularly in the past three months.You have taken any kind of steroid medication, like corticosteroids, in the last 30 days.You are allergic to any of the study medications like lidocaine, Versed, fentanyl, or Cetacaine.You have immune system disorders that require medication.You have had issues with alcohol or drug abuse in the past three months.You are currently using nicotine replacement or other products to help you quit smoking, or you plan to quit smoking within the next three months.You have been diagnosed with kidney or liver disease in the past.You have a long-term lung condition like asthma, COPD, chronic bronchitis, or restrictive lung disease that requires regular use of medications.
Research Study Groups:
This trial has the following groups:- Group 1: Group IV (Nicotine Replacement Therapy [NRT])
- Group 2: Group I (usual cigarette brand)
- Group 3: Group II (SREC with nicotine)
- Group 4: Group III (SREC without nicotine)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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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