Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs

Summary

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.

Conditions

• Cigarette Smoker
• Current Every Day Smoker

Interventions

PROCEDURE

Bronchoscopy with Bronchoalveolar Lavage

Undergo bronchoscopy with bronchoalveolar lavage

DRUG

Cigarette

Smoke usual brand

OTHER

Electronic Cigarette

Smoke SREC with nicotine

OTHER

Electronic Cigarette

Smoke SREC without nictoine

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nicotine Replacement

Receive NRT comprising patch, gum, or lozenge

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Peter Shields, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

52 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-17

Primary Completion

2023-10-23

Completion

2024-03-10

FDA Drug

Yes

Countries

• United States

Study Locations