Bronchoscopy to Study E-Cigarette Effects in Cigarette Smokers

Recruiting in Palo Alto (17 mi)

Overseen byPeter Shields, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Peter Shields, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Able to read adequately to complete the survey and related study documents or give consent

Subject has provided written informed consent to participate in the study

You smoke at least 5 cigarettes with filters per day for at least 1 year.

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Exclusion Criteria

You have had bronchitis or pneumonia in the past year.

You have had general anesthesia within the past year.

Bronchoscopy or any other lung procedure for any reason within the previous 6 months

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Treatment Details

Interventions

Bronchoscopy with Bronchoalveolar Lavage (Procedure)
Questionnaire Administration (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.