A Trial of E-cigarettes in Current Cigarette Smokers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine cigarette smokers' use of electronic cigarettes (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.

Detailed Description
-----------------
Study initiation will commence after the first telephone contact (phone pre-screen), at the baseline visit. Additional lab visits will occur at days 8, 15, and 22 (visits 2-4). At the first study visit, 2/3rds of the participants will be randomly assigned to sample e-cigarettes and 1/3rd will not. Participants in the e-cigarette group will be provided with sufficient product to sample and use as they wish, but with minimal instruction on purpose and level of use (non-use is an outcome). Smokers in the control group will smoke their own brand of cigarettes, as they wish, for the duration of the sampling period. All participants will engage in ecological momentary assessments, which will be completed 3 times daily for 3 weeks. In-person follow-up assessments will be conducted at 1, 2, and 3 months after the final lab visit (Day 22). Overall, each participant will be contacted 8 times: at the phone pre-screening, the 4 lab visits, and 3 follow-up visits.

Official Title
-----------------
A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use

Conditions
-----------------
Smoking, Nicotine Dependence, Nicotine Dependence, Other Tobacco Product

Intervention / Treatment
-----------------
* Other: electronic cigarette
* Other: cigarette group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18+ current smoker of at least 5 cigarettes per day for at least 1 year at least some concern for health effects of smoking having an easily accessible email address Exclusion Criteria: past six month use of any e-cigarette lifetime ever purchase of any e-cigarette recent history of cardiovascular distress (heart attack in past year; arrhythmia; uncontrolled hypertension) recent history (past 3 months) of Chronic Obstructive Pulmonary Disease (COPD), cancer (any non-dermatologic), or uncontrolled diabetes mellitus pregnant or breastfeeding any major current psychiatric impairment, including current alcohol/drug abuse/dependence use of non-cigarette tobacco products (e.g., cigarillos) in the last 30 days current use of any smoking cessation medications current enrollment in a smoking cessation treatment study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
No

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 |
| --- | --- |
| Active Comparator: cigarette group<br>This group (1/3 of the sample) will not receive electronic cigarettes to sample and will continue smoking their regular cigarettes as much or as little as they would like. | Other: cigarette group<br> <br> |
| Experimental: electronic cigarette<br>This group (2/3 of the sample) will be given electronic cigarettes for a 3-week period, to use as much or as little as they would like. | Other: electronic cigarette<br> <br> * Other names: Blu ecigs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of Electronic Nicotine Delivery Systems (ENDS) | % of participants by group used e-cigarettes in week 16 | study week 16 | 
| Independent Purchase of an ENDs Product | % of participants by group who purchased an ENDs product on their own during the study | study enrollment to study week 16 | 
| % Quit Attempts | % of participants who made any quit attempt during study | study enrollment to study week 16 | 
| Point Prevalence Abstinence | % of participants with CO-verified cigarette abstinence at study week 16 | week 16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, nicotine, tobacco products, electronic cigarette