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Switching to Potential Reduced Exposure Products in Adult Smokers (JUUL)

  • Study HIC#:2000023826
  • Last Updated:07/15/2021

Brief Summary:

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, non-combustible tobacco products in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 50 non-treatment seeking adult smokers with medical co-morbidities to investigate within-person changes in smoking behavior as a result of switching to different concentrations a nicotine salt electronic cigarette product (i.e. JUUL, 3% and 5% nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to an e-cigarette device.

  • Age21 years - 77 years
  • GenderBoth
  • Start Date12/10/2018
  • End Date09/30/2022

Trial Purpose and Description

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, non-combustible tobacco products in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 50 non-treatment seeking adult smokers with medical co-morbidities to investigate within-person changes in smoking behavior as a result of switching to different concentrations a nicotine salt electronic cigarette product (i.e. JUUL, 3% and 5% nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to an e-cigarette device.

Eligibility Criteria

Inclusion Criteria:

  1. 18-65 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)
  2. English literate
  3. Smoke at least 5 cigarettes per day for the past 6 months
  4. Expired breath carbon monoxide level ≥ 6ppm at baseline or detected urine cotinine level with NicAlert test strip
  5. Not currently interested in smoking cessation services or quitting
  6. Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline).
  7. Medical co-morbidity (i.e., hypertension, diabetes, asthma, COPD/emphysema, cardiovascular disease, stroke, cancer, HIV)

Exclusion Criteria:

  1. Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
  2. History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
  3. Current uncontrolled medical condition
  4. Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation)
  5. Current use of drugs identified by urine drug screen or other tobacco products identified by self-report
  6. Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study
  7. Severe lung disease that requires supplemental oxygen
  8. History of vaping cannabis products in the past 3 months or positive drug screen for THC
  9. Uncontrolled asthma (<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
  10. Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
  11. ECG showing ischemic changes or tachyarrhythmias
  12. Planning to quit smoking with a set goal or time for quit attempt
  13. Known hypersensitivity to propylene glycol
  14. Patients with an FEV1 < 40%

Sub-Investigators

  • Roy S. Herbst

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