Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns

Study Overview
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Brief Summary
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The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.

Official Title
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Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns Among

Conditions
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Smoking, Tobacco Use

Intervention / Treatment
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* Behavioral: Low Power
* Behavioral: High Power
* Behavioral: Low Concentration
* Behavioral: High Concentration


Participation Criteria
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Eligibility Criteria
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Inclusion criteria include adults who have been smoking daily interested in using e-cigarettes who have a smartphone that can receive text messages and access to the internet or has an e-mail account that they check daily Exclusion criteria include minimal prior e-cigarette use use of tobacco products other than cigarettes current use of cessation medications pregnant, trying to become pregnant, or breastfeeding, recent history of cardiovascular distress in the last three months (e.g., arrhythmia, heart attack, stroke, uncontrolled hypertension), household member currently enrolled in the study.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Concentration / Low Power<br>Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks. | Behavioral: Low Power<br>* Participants will receive a low power e-cigarette to use for 3 weeks<br>Behavioral: Low Concentration<br>* Participants will receive a low concentration e-liquid to use for 3 weeks<br>|
| Experimental: Low Concentration / High Power<br>Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks. | Behavioral: High Power<br>* Participants will receive a high power e-cigarette to use for 3 weeks<br>Behavioral: Low Concentration<br>* Participants will receive a low concentration e-liquid to use for 3 weeks<br>|
| Experimental: High Concentration / Low Power<br>Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks. | Behavioral: Low Power<br>* Participants will receive a low power e-cigarette to use for 3 weeks<br>Behavioral: High Concentration<br>* Participants will receive a high concentration e-liquid to use for 3 weeks<br>|
| Experimental: High Concentration / High Power<br>Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks. | Behavioral: High Power<br>* Participants will receive a high power e-cigarette to use for 3 weeks<br>Behavioral: High Concentration<br>* Participants will receive a high concentration e-liquid to use for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Cigarettes Per Day | Participants complete daily electronic diaries reporting the number of cigarettes smoked each day on a continuous scale | up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of E-cigarette Puffing Episodes | Participants complete daily electronic diaries reporting the number of e-cigarette puffing episodes each day on a continuous scale | up to 3 Weeks | 
| Number of Choices to Smoke Cigarette in Lab Setting | Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette. | Week 3 |