Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study
NCT ID: NCT04231539
Last Updated: 2025-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2020-02-18
2024-07-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Product Sequence D
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product Sequence A then B then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Product sequence B then C then A then D
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence D then B then A then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence C then D then B then A
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence A then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Product sequence D then C then B then A
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence A then D then B then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence D then A then C then B
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence C then D then A then B
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence A then C then D then B
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product Sequence A then B then D then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence B then A then D thn C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Product sequence B then D then C then A
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine 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.
Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Interventions
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Nicotine
Vape Free-Low nicotine unflavored
Vaporizer Device
Take puffs from vaporizer filled with different flavors
Salt-HIgh Nicotine Unflavored (Product B)
Vape Salt-High nicotine unflavored
Free-Low Nicotine Tobacco Flavored (Product C)
Vape Free-Low Nicotine Tobacco
Salt-High Nicotine Tobacco Flavored (Product D)
Vape Salt-High Tobacco
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current daily ENDS user as determined by
* Has used ENDS product every day for the past 6 months (by history)
* Has used ENDS product or e-liquid containing nicotine (by history)
* Participant or legal representative must understand the investigational nature of this study and sign and Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
* Currently smokes \>= 5 cigarettes per month
* Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, or glaucoma) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current regular use of psychiatric medications (such as major tranquilizers and antidepressants)
* History of serious side effects from nicotine or from any nicotine replacement therapies
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing females
* Concurrent participation in another clinical trial
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate
21 Years
55 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Amanda Quisenberry
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2019-07370
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 475819
Identifier Type: OTHER
Identifier Source: secondary_id
I 475819
Identifier Type: -
Identifier Source: org_study_id
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