Examination of Low Wattage and High Wattage E-Cigarettes

Study Overview
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Brief Summary
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The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects.

Official Title
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Examination of Low Wattage and High Wattage E-Cigarettes

Conditions
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Smoking, Cigarette, Smoking, Tobacco, Nicotine Dependence, Exposure to Toxic Agent

Intervention / Treatment
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* Behavioral: Low wattage E cigarette device
* Behavioral: HIgh wattage E cigarette device
* Behavioral: Usual brand cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoke ≥5 cigarettes per day for the past year; no quit attempt in the prior 3 months and no plan to quit in the next 3 months; read, write, and speak in English; report at least minimal interest in switching to an alternative product (> not at all on a Likert scale); never purchased or regularly used a tank system, mechanical mod, or advanced personal vaporizer EC, though previous use of cig-a-like devices will be allowed but not in the last 3 months; plan to live in the local area for next year; and have reliable means of transport. - Exclusion Criteria: <18 years old; unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data; unstable or significant psychiatric conditions (past and stable conditions will be allowed); history of cardiac event or distress within the past 3 months; and currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit). -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low wattage E cigarette device<br> | Behavioral: Low wattage E cigarette device<br>* The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.<br>|
| Active Comparator: High wattage E cigarette device<br> | Behavioral: HIgh wattage E cigarette device<br>* The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.<br>|
| Active Comparator: Usual brand cigarette<br> | Behavioral: Usual brand cigarette<br>* The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete change from conventional cigarettes | Timeline Follow Back Questionnaire | Baseline, Week1, Week 4, Week 8, Week 12, Week 26, and Week 52 | 
| Complete change from conventional cigarettes | Exhaled carbon monoxide of ≤10ppm | Baseline, Week1, Week 4, Week 8, Week 12, Week 26, and Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EC Dependence | Cigarette Dependence Scale | Week -1, Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52 | 
| EC Likeability/Preference | Cigarette Evaluation Scale; and EC modified-Cigarette Evaluation Scale | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| EC Abuse Liability | Drug Effects/Liking Questionnaire | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - NNAL | Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (ng/g creatinine) | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - NNN | Presence of urinary [pyridine-D4]NNN ([D4]NNN) | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - Total Nicotine Equivalents (TNE) | Sum of nicotine and metabolites in urine | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - Nicotine Metabolite Ratio | Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine [3HC]/cotinine) | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - Nickel and other relevant metals | Metals and metalloids in saliva | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - Cadmium and other relevant metals | Metals and metalloids in saliva | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - Lead and other relevant metals | Metals and metalloids in saliva | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - 8-iso-PGF2a | Urinary biomarker of oxidative stress and inflammation | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Exposure - PGEM | Urinary biomarker of oxidative stress and inflammation | Baseline, Week 4, Week 12, Week 26, and Week 52 | 
| Biomarker of Effect - q-PADDA | Quantifies DNA damage | Baseline, Week 4, Week 12, Week 26, and Week 52 |