Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

Conditions
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Nontherapeutic

Intervention / Treatment
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* Other: e-cigarette
* Other: cigarette substitute


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cigarette substitute<br>The QuitSmart cigarette substitute is a plastic tube that looks like a real cigarette and is designed to provide the same draw resistance as a smoker's usual cigarette. There is no drug delivery with this product. Two cigarette substitutes and a product manual are provided to participants following randomization and replacement products are provided throughout the intervention period (24 weeks). | Other: cigarette substitute<br> <br> |
| Experimental: e-cigarette (with 0 mg/ml nicotine)<br>The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 0 mg/ml nicotine will be provided throughout the intervention period (24 weeks). | Other: e-cigarette<br> <br> |
| Experimental: e-cigarette (with 8 mg/ml nicotine)<br>The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 8 mg/ml nicotine will be provided throughout the intervention period (24 weeks). | Other: e-cigarette<br> <br> |
| Experimental: e-cigarette (with 36 mg/ml nicotine)<br>The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 36 mg/ml nicotine will be provided throughout the intervention period (24 weeks). | Other: e-cigarette<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine carcinogen biomarker of exposure, NNAL | changes in NNAL concentration measured at week 0, week 4, week 12, and week 24 | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine biomarker of nicotine exposure, cotinine | changes in cotinine concentration measured at week 0, week 4, week 12, and week 24 | week 24 | 
| blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes | changes in oxidative stress biomarker concentrations measured at week 0, week 4, week 12, and week 24 | week 24 |