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N/A

Bronchoscopy for Tobacco Use Disorder

N/A
Waitlist Available
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 up to week 5
Awards & highlights

Study Summary

This trial looks at the effects of e-cigarettes on the lungs. The results may help the FDA make e-cigarettes safer.

Eligible Conditions
  • Tobacco Use Disorder
  • Smokers
  • Never Smokers
  • Ex-Smoker
  • Electronic Cigarette User

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biomarker expression analysis to include cell counts
Biomarker expression analysis to include gene expression (Part I)
Biomarker expression analysis to include inflammatory cytokines (Part I)
+2 more

Side effects data

From 2020 Phase 2 trial • 28 Patients • NCT02230189
5%
Pregnancy identified during study enrollment
5%
Increased systolic blood pressure post-bronchoscopy
5%
Respiratory infection post-bronchoscopy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allergic Asthmatics(AA)
Allergic Non-Asthmatics(ANA)
Non-Allergic Non-Asthmatics(NANA)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm II (bronchoscopy of the right lung)Experimental Treatment3 Interventions
Patients undergo bronchoscopy of the right lung over 30-60 minutes.
Group II: Arm I (bronchoscopy of the left lung)Experimental Treatment3 Interventions
Patients undergo bronchoscopy of the left lung over 30-60 minutes.
Group III: Arm B (control)Experimental Treatment3 Interventions
Patients receive no intervention. Patients undergo a second bronchoscopy during week 5.
Group IV: Arm A (electronic-cigarette)Experimental Treatment4 Interventions
Patients receive nicotine-free and flavor-free electronic cigarettes and instructed to use them BID over a 2 hour period for 4 weeks. Patients undergo a second bronchoscopy during week 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bronchoscopy
2002
Completed Phase 2
~2300

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,130 Total Patients Enrolled
93 Trials studying Tobacco Use Disorder
1,682,688 Patients Enrolled for Tobacco Use Disorder
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,025 Total Patients Enrolled
3 Trials studying Tobacco Use Disorder
820 Patients Enrolled for Tobacco Use Disorder
Peter Shields, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
3,233 Total Patients Enrolled

Media Library

Electronic Cigarette (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT02596685 — N/A
Tobacco Use Disorder Research Study Groups: Arm II (bronchoscopy of the right lung), Arm A (electronic-cigarette), Arm B (control), Arm I (bronchoscopy of the left lung)
Tobacco Use Disorder Clinical Trial 2023: Electronic Cigarette Highlights & Side Effects. Trial Name: NCT02596685 — N/A
Electronic Cigarette (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02596685 — N/A

Frequently Asked Questions

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

Is it feasible for me to enroll in this clinical trial?

"This experimental trial is recruiting 208 participants between the ages of 21 and 45, who are current smokers."

Answered by AI

Are geriatric patients eligible for participation in this research endeavor?

"As stated by the inclusion criteria, those looking to be enrolled in this clinical trial are required to fall within the 21-45 age range. There are also separate studies for younger and older patients, at 4 and 84 respectively."

Answered by AI

What is the peak capacity of participants in this clinical experiment?

"Correct. Clinicaltrials.gov states that this experiment is actively enrolling patients, initially published on December 8th 2015 and amended most recently on August 4th 2022. A total of 208 subjects are needed from a single trial site."

Answered by AI

Are any additional participants being enrolled in this trial?

"Affirmative. According to records on clinicaltrials.gov, the enrolment of participants is still open for this medical trial which was first posted on December 8th 2015 and recently updated on August 4th 2022. 208 individuals are expected to be recruited at one location."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Illinois
How old are they?
18 - 65
What site did they apply to?
Ohio State University Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Effects of Electronic Cigarette Use on the Lungs
Peter Shields 2015. "Effects of Electronic Cigarette Use on the Lungs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02596685.
~15 spots leftby Apr 2025
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