Effects Among Smokers Who Use and Do Not Use E-Cigarettes

Study Overview
=================
Brief Summary
-----------------
This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.

Official Title
-----------------
Effects Among Smokers Who Use and Do Not Use E-Cigarettes

Conditions
-----------------
Toxicant Exposure

Intervention / Treatment
-----------------
* Other: E-Cigarette Vs. Smoking as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 21 years of age Smoked cigarettes on > 25 of past 30 days Smoked > 5 cigarettes per day on days smoked Smoked cigarettes > 6 months Carbon monoxide > 5 PPM at baseline Hispanic/Latino or African American/Black Fluent in English or Spanish Willing to switch from smoking cigarettes to ECs for 6 weeks Regular access to telephone Transportation to attend appointments (KC Only) Exclusion Criteria: Primary use of other tobacco products or equal use of cigarettes and other tobacco products Electronic cigarette use on > 4 of the past 30 days Currently in a smoking cessation program or another clinical trial Use of nicotine replacement therapy or medication which aids smoking cessation in the past 30 days Hospitalization for a psychiatric issue in the past 30 days Heart-related event in the past 30 days. Examples include heart attack, stroke, severe angina (i.e. chest pain), ischemic heart disease, and vascular disease Uncontrolled blood pressure at baseline Planning to move out of San Diego or Kansas City in the next 6 weeks Another person in the household enrolled in the study Women: pregnant, breastfeeding, or planning to become pregnant in the next six months Unstable mental status or health status

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-Cigarette<br>6 weeks of JUUL electronic cigarettes | Other: E-Cigarette Vs. Smoking as Usual<br>* 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual<br>|
| Active Comparator: Assessment Only<br>6 weeks of smoking as usual | Other: E-Cigarette Vs. Smoking as Usual<br>* 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicant Exposure | Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon Monoxide | Carbon monoxide at week 6. Breath test (PPM) | 6 weeks | 
| Respiratory Symptoms | Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes | 6 weeks | 
| Lung Function | FEF 25%-75%, L/s at week 6 measured by spirometer | 6 weeks | 
| Systolic Blood Pressure | Systolic blood pressure at week 6 | 6 weeks | 
| Diastolic Blood Pressure | Diastolic blood pressure at week 6 | 6 weeks | 
| Tobacco Dependence | Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes | 6 weeks | 
| Self-efficacy to Resist Smoking | Self-efficacy to resist smoking at week 6. Brief Self Efficacy to Resist Smoking Cigarettes Scale; total score ranges from 0-60, higher score reflects better outcome | 6 weeks |