RecruitingNot ApplicableNCT06448351

Manipulating E-Cigarette Nicotine to Promote Public Health


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

350 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria4

  • Current exclusive young adult EC user for at least the past 3 months (confirmed by cotinine testing strip) between 21-24 years old with no/minimal history of smoking cigarettes (≤ 10 cigarettes in entire life)
  • Current older adult smoker (daily use, ≥ 100 cigarettes in entire life) aged 25-65 with interest in trying an EC
  • Willing to abstain from all nicotine, tobacco products, and marijuana for at least 12 hours before study visits
  • Read and speak English

Exclusion Criteria6

  • Currently attempting to quit nicotine or tobacco products
  • Currently pregnant (will be verified with urine pregnancy test), planning to become pregnant, or breastfeeding
  • If age 21-24 years old AND use of any tobacco products other than ECs (use of >10 cigarettes in entire life; use of >10 traditional cigars, cigarillos, or filtered cigars in entire life; use of smokeless tobacco products >10 times in entire life; or hookah in the last 30 days).
  • Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
  • New or unstable cardiovascular disease diagnosed within the past 3 months
  • Use of medications that are inducers of CYP2A6 enzyme such as rifampicin, dexamethasone, phenobarbital, and other anti-convulsion drugs

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

PROCEDURECarbon Monoxide Measurement

Undergo CO test

OTHERVaping session

Sample study e-liquids in vaping sessions at research lab with e-cig study device

OTHERSurvey Administration

Ancillary studies


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06448351


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