Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

Study Overview
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Brief Summary
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This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.

Official Title
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Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

Conditions
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Electronic Cigarettes

Intervention / Treatment
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* Other: E-cigarette Lab Session 15 watts, 10 mg nicotine
* Other: E-cigarette Lab Session 15 watts, 30 mg nicotine
* Other: E-cigarette Lab Session 30 watts, 10 mg nicotine
* Other: E-cigarette Lab Session 30 watts, 30 mg nicotine
* Other: Own Brand Session - E-cigarette
* Other: Own Brand Session - E-cigarette/Cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy (determined by self-report) between the ages of 21-55 willing to provide informed consent able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol Exclusion Criteria: Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening. Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 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: Crossover Assignment
Interventional Model Description: We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes. All participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette. The first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-cigarette User (Exclusive)<br>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette | Other: E-cigarette Lab Session 15 watts, 10 mg nicotine<br>* E-cigarette paired with low nicotine, low device power<br>Other: E-cigarette Lab Session 15 watts, 30 mg nicotine<br>* E-cigarette paired with low nicotine, low device power<br>Other: E-cigarette Lab Session 30 watts, 10 mg nicotine<br>* E-cigarette paired with low nicotine, low device power<br>Other: E-cigarette Lab Session 30 watts, 30 mg nicotine<br>* E-cigarette paired with low nicotine, low device power<br>Other: Own Brand Session - E-cigarette<br>* E-cigarette paired with own brand liquid and preferred power<br>|
| Active Comparator: Dual User<br>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette | Other: E-cigarette Lab Session 15 watts, 10 mg nicotine<br>* E-cigarette paired with low nicotine, low device power<br>Other: E-cigarette Lab Session 15 watts, 30 mg nicotine<br>* E-cigarette paired with low nicotine, low device power<br>Other: E-cigarette Lab Session 30 watts, 10 mg nicotine<br>* E-cigarette paired with low nicotine, low device power<br>Other: E-cigarette Lab Session 30 watts, 30 mg nicotine<br>* E-cigarette paired with low nicotine, low device power<br>Other: Own Brand Session - E-cigarette<br>* E-cigarette paired with own brand liquid and preferred power<br>Other: Own Brand Session - E-cigarette/Cigarette<br>* Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breakpoint of Drug Purchase Tasks (DPT) | The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). | Up to 180 minutes | 
| Breakpoint of Multiple Choice Procedure (MCP) | The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). | Up to 180 minutes. | 
| Effort for Product Puffs With the Progressive Ratio Task (PRT) | The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). | Up to 180 minutes. |