Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)

Study Overview
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Brief Summary
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This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.

Official Title
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Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)

Conditions
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Electronic Cigarette Use

Intervention / Treatment
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* Other: Tobacco product administration and assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy (determined by self-report) between the ages of 18-55 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: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Own Brand Cigarette<br> | Other: Tobacco product administration and assessment<br>* 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment<br>|
| Experimental: ECIG 30 Watts, 0 mg/ml nicotine<br> | Other: Tobacco product administration and assessment<br>* 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment<br>|
| Experimental: ECIG 30 Watts, 8 mg/ml nicotine<br> | Other: Tobacco product administration and assessment<br>* 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment<br>|
| Experimental: ECIG 30 Watts, 15 mg/ml nicotine<br> | Other: Tobacco product administration and assessment<br>* 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment<br>|
| Experimental: ECIG 30 Watts, 30 mg/ml nicotine<br> | Other: Tobacco product administration and assessment<br>* 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breakpoint of Drug Purchase Task (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, about 75 minutes into the session. | 
| Effort for Product Puffs with 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) through three outcome measures. 1) Breakpoint (maximum number of key presses completed to earn a puff), 2) number of puffs self-administrated, and 3) latency (seconds) to initiate key pressing. | The PRT is completed once per study session, about 90 minutes into the session. | 
| Effort for Product Puffs with Cross Product Progressive Ratio Task (CP-PRT) | The CP-PRT will yield a measure of willingness to work for either the session-specific ECIG or the participants own brand tobacco products (via bar presses/work requirement that increases for each of 10 trials for the own brand product while the session-specific product is available for a fixed work requirement). The main outcome of interest in the CP-PRT is the relative reinforcing value - defined as how hard a participant is willing to work for the session product compared to their own brand cigarette. The breakpoint, or highest trial number that a participant completed for a puff of the session-specific product will be used as the measure of relative reinforcing value. | The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic Cigarette, Nicotine Flux