This trial studies activity of time (pharmacokinetics), subjective effects, and abuse liability of nicotine salt-based vaping products with tobacco or e-liquids. This study aims to determine and compare the levels of nicotine delivered to the bloodstream from nicotine salt and free-base nicotine e-liquid solutions.
PRIMARY OBJECTIVES: I. To determine the effect of nicotine salt (nicotine benzoate) and free-base nicotine in different flavored e-liquid solutions on puffing behaviors and systemic exposure to nicotine from electronic nicotine delivery systems (ENDS) by: Ia. Assessing short-term effects on nicotine cravings, withdrawal, and satisfaction from single use of ENDS refilled with flavored nicotine salt or flavored free-base nicotine solutions with two different flavors (tobacco or unflavored) in current daily ENDS users following an overnight fast. Ib. Comparing users' perceptions and preferences towards inhaling vapors containing nicotine salt (nicotine benzoate) or freebase nicotine with two different flavors (tobacco and unflavored) versus their regular brand. II. This project provides important information on whether the pharmacokinetics of nicotine delivery differ between salt and free-base forms of e-liquid of equivalent nominal concentration using the same device, and whether the previously observed effects of flavors on subjective effects differ between salt and free-base forms. III. Determine whether maximum concentration of nicotine in plasma (Cmax) or time to maximum concentration (Tmax) differ between free-base and salt-based versions of the same liquid, controlling for flavoring and nominal nicotine concentration \[main effect of salt\]. IV. Determine whether the effect of flavoring on subjective effects (e.g., harshness, liking) differs between matched free-base and salt-based e-liquids \[flavor X salt interaction\]. EXPLORATORY OBJECTIVE: I. Examine effects of salt and flavoring on abuse liability using the Experimental Tobacco Marketplace (ETM). OUTLINE: After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours, 5-7 days apart. During each session, participants take 20 puffs over 10 minutes (one puff every 30 seconds) of vaporizer filled with freebased nicotine electronic (e)-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
15
Vape Free-Low nicotine unflavored
Take puffs from vaporizer filled with different flavors
Vape Salt-High nicotine unflavored
Roswell Park Cancer Institute
Buffalo, New York, United States
Maximum Concentration of Nicotine in Plasma (Cmax)
The maximum nicotine concentration in blood plasma
Time frame: Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4.
Area Under the Concentration-time Curve (AUC)
Area under the plasma nicotine concentration over time curve
Time frame: Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4.
Time to Maximum Concentration
Time to maximum nicotine concentration in the blood plasma
Time frame: Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4.
Perceived Harshness of Experimental Product Sampled
Subjective Measure of Perceived Harshness (Likert, 1-5: 1 = best outcome, 5 = worst outcome).
Time frame: 1 minute post puffing for 4 weeks
Perceived Satisfaction of Experimental Product Sampled
Nicotine Solution Rating Scale that orders each of the four products from 1 to 4, with 1 being least satisfying and 4 being most satisfying. Mean rank is provided with a possible score of 1 through 4.
Time frame: 120 minutes after session start on last session (session 4)
Perceived Liking of Experimental Product Sampled
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Vape Free-Low Nicotine Tobacco
Vape Salt-High Tobacco
Drug Effects Questionnaire Item #1 - perceived liking of the experimental product assessed by the question, "Do you like any of the effects you are feeling right now?" on a Likert scale from 0 (not at all) to 100 (extremely), with lower scores representing less liking of the experimental product. Mean is provided with possible scores between 0 and 100.
Time frame: 1 minute post puffing for 4 weeks
Minnesota Nicotine Withdrawal Scale Change (Change From Pre- to Post-)
Minnesota Nicotine Withdrawal Scale Change Minnesota Nicotine Withdrawal scale measures 8 facets of withdrawal and results in a total score. We use change from 5 minutes Pre-puffing to 3 minutes post puffing session. Individual questions are scored 0 (none/better) to 4 (severe/worse). And then the scores are totaled. Positive change score = more withdrawal symptoms. Change score can range from -32 to 36). Positive change score = worse withdrawal symptoms Individual questions are scored 0 (none/better) to 4 (severe/worse). And then the scores are totaled.
Time frame: 5 minutes pre puffing and 3 minutes post puffing for 4 weeks