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Nicotine DependenceNCT04231539

Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study

A study testing Nicotine, Vaporizer Device and Salt-HIgh Nicotine Unflavored (Product B) in people with Nicotine Dependence, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Nicotine Dependence
What is being tested?
Nicotine, Vaporizer Device and Salt-HIgh Nicotine Unflavored (Product B)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
18 Feb 2020to 10 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Willingness to abstain from using ENDS product for 8-10 hours (overnight abstinence) prior to study visits
  • 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

Who cannot join

  • Smoked cigarettes in the past 7 days
  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids[SALTVAPE Study]

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Nicotine, Vaporizer Device, Salt-HIgh Nicotine Unflavored (Product B), Free-Low Nicotine Tobacco Flavored (Product C), Salt-High Nicotine Tobacco Flavored (Product D)
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NicotineDrug

    Also called Free-Low Nicotine Unflavored (Product A), NIC

    Vape Free-Low nicotine unflavored

  • Vaporizer DeviceDevice

    Also called Vaporizer

    Take puffs from vaporizer filled with different flavors

  • Salt-HIgh Nicotine Unflavored (Product B)Drug

    Vape Salt-High nicotine unflavored

  • Free-Low Nicotine Tobacco Flavored (Product C)Drug

    Vape Free-Low Nicotine Tobacco

  • Salt-High Nicotine Tobacco Flavored (Product D)Drug

    Vape Salt-High Tobacco

Study groups in NCT04231539
Study groupRoleWhat they receive
Product Sequence DExperimentalAfter 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.
Receives: Device: Vaporizer Device; Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product Sequence A then B then CExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C)
Product sequence B then C then A then DExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence D then B then A then CExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence C then D then B then AExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence A then CExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Free-Low Nicotine Tobacco Flavored (Product C)
Product sequence D then C then B then AExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence A then D then B then CExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence D then A then C then BExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence C then D then A then BExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence A then C then D then BExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product Sequence A then B then D then CExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence B then A then D thn CExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)
Product sequence B then D then C then AExperimentalAfter 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.
Receives: Drug: Nicotine; Device: Vaporizer Device; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Drug: Salt-High Nicotine Tobacco Flavored (Product D)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Concentration of Nicotine in Plasma (Cmax)

    The maximum nicotine concentration in blood plasma

    Measured: 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.

  2. Area Under the Concentration-time Curve (AUC)

    Area under the plasma nicotine concentration over time curve

    Measured: 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.

  3. Time to Maximum Concentration

    Time to maximum nicotine concentration in the blood plasma

    Measured: 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.

Secondary outcomes (4)

  1. Perceived Harshness of Experimental Product Sampled

    Subjective Measure of Perceived Harshness (Likert, 1-5: 1 = best outcome, 5 = worst outcome).

    Measured: 1 minute post puffing for 4 weeks

  2. 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.

    Measured: 120 minutes after session start on last session (session 4)

  3. Perceived Liking of Experimental Product Sampled

    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.

    Measured: 1 minute post puffing for 4 weeks

  4. 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.

    Measured: 5 minutes pre puffing and 3 minutes post puffing for 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start18 Feb 2020
  3. Primary completion10 Jul 2024
  4. Study completion10 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
The participant and researcher will be blinded to solution flavor and nicotine concentrates.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04231539
Sponsor's protocol ID
I 475819
Other IDs
NCI-2019-07370, I 475819, U54CA228110
Status last verified
Oct 2025
First submitted
10 Jan 2020
Last updated
31 Oct 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Block AC, Martin CD, Leigh NJ, Page MK, Kaiser LM, Nardotto GHB, Rosario SR, Felicione NJ, O'Connor RJ, Goniewicz ML, Quisenberry AJ. Effects of nicotine form and tobacco flavor on pharmacokinetics, subjective effects, and behavioral indicators of abuse liability of e-cigarettes. Nicotine Tob Res. 2026 Aug 24;28(9):1489-1497. doi: 10.1093/ntr/ntag058.

    PubMed 41863629

Questions about this trial

What is this clinical trial studying?

A study testing Nicotine, Vaporizer Device and Salt-HIgh Nicotine Unflavored (Product B) in people with Nicotine Dependence, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Concentration of Nicotine in Plasma (Cmax) (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04231539, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

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