Nontherapeutic
Conditions
Brief summary
The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. In this case, the novel products are one type of electronic cigarette and an imitation cigarette or cigarette substitute.
Interventions
OTHERe-cigarette
OTHERcigarette substitute
Sponsors
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
Penn State University
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21-65 * Smoke \>9 cigarettes per day for at least 1 year * Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter * CO measurement \>9 ppm at baseline * No serious quit attempt in the prior 1 month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion \[used specifically as a quitting aid\], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking. * Not planning to quit in the next 6 months * Interested in reducing cigarette consumption * Willing to attend visits weekly and monthly over a 9-month period (not planning to move, not planning extended vacation, no planned surgeries) * Read and write in English * Able to understand and consent
Exclusion criteria
* Pregnant and/or nursing women * Unstable or significant medical condition in the past 12 months (Recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure if systolic \>159 or diastolic \>99 observed during screening). * Immune system disorders, respiratory diseases (exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data. * Use of any non-cigarette nicotine delivery product (pipe, cigar, dip, chew, snus, hookah, ECIGs, strips, sticks) in the past 7 days * Uncontrolled mental illness or substance abuse or inpatient treatment for these in the past 6 months * History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety) * No surgery requiring general anesthesia in the past 6 weeks * Use of an ECIG for 5 or more days in the past 28 days or any use in the past 7 days * Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily, or weekly in the past 3 months per NIDA Quick Screen * Use of hand-rolled, roll your own cigarettes * Known allergy to propylene glycol or vegetable glycerin * Other member of household is currently participating/participated in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urine carcinogen biomarker of exposure, NNAL | week 24 | changes in NNAL concentration measured at week 0, week 4, week 12, and week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| urine biomarker of nicotine exposure, cotinine | week 24 | changes in cotinine concentration measured at week 0, week 4, week 12, and week 24 |
| blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes | week 24 | changes in oxidative stress biomarker concentrations measured at week 0, week 4, week 12, and week 24 |
Countries
United States
Outcome results
None listed