E Cig Use Clinical Trial
Official title:
Young Adult EC Use and Respiratory Outcomes
E-cigarette (EC) use continues to increase among youth, and EC may be detrimental to youth respiratory health. Public health officials and the Food and Drug Administration (FDA) can now regulate ECs. The proposed study uses naturalistic assessments called ecological momentary assessment (EMA) to understand how ECs use may impact the respiratory health of youth and young adult users compared to never-using peers.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | July 15, 2024 |
| Est. primary completion date | May 15, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 25 Years |
| Eligibility | Inclusion Criteria: 1. own a smartphone and willing to add study EMA and spirometry application to it. 2. a current exclusive-EC user (endorse =weekly use over the past 3 months) and report never trying OTPs 3. between the ages of 18-25 years old at the time of enrollment 4. read and speak English 5. willing to complete five, 2-week periods of daily EMA and home-based spirometry 6. never-users must indicate never trying any tobacco product to be eligible for enrollment Exclusion Criteria: 1. self-reported diagnosis of lung disease including cystic fibrosis or chronic obstructive pulmonary disease; we will not exclude youth who have asthma, but will incorporate this as a covariate during analyses 2. unstable or significant psychiatric conditions (past and stable conditions will be allowed) 3. history of cardiac event or distress within the past 3 months 4. are currently pregnant, planning to become pregnant, or breastfeeding |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Ohio State University | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University Comprehensive Cancer Center | Food and Drug Administration (FDA), National Heart, Lung, and Blood Institute (NHLBI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Spirometry to measure the change from baseline in forced vital capacity (FVC) | Spirometry (a pulmonary function diagnostic test) will be completed during each session. For e-cigarette users, assessments will be completed in session. | Baseline, 3-month, 6-month, 9-month, 12-month | |
| Primary | Spirometry to measure the change from baseline in forced expiratory volume (FEV) | Spirometry (a pulmonary function diagnostic test) will be completed during each session. For e-cigarette users, assessments will be completed in session. | Baseline, 3-month, 6-month, 9-month, 12-month | |
| Primary | Level of dependence by product type will be examined. | Changes in product use evaluated with an evaluation of the changes in dependence using the Hooked on Nicotine Checklist (HONC). | Baseline, 3-month, 6-month, 9-month, 12-month | |
| Primary | Respiratory health measures by nasal swab. | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04063267 -
Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
|
Phase 2 |