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

NCT04231539 | Completed Results

• 3 other identifiers: I 475819NCI-2019-07370U54CA228110
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (3)

• Maximum Concentration of Nicotine in Plasma (Cmax)

  The maximum nicotine concentration in blood plasma

  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

  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

  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)

• Perceived Harshness of Experimental Product Sampled

  1 minute post puffing for 4 weeks

• Perceived Satisfaction of Experimental Product Sampled

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

• Perceived Liking of Experimental Product Sampled

  1 minute post puffing for 4 weeks

• Minnesota Nicotine Withdrawal Scale Change (Change From Pre- to Post-)

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

Other Outcomes (3)

• Intensity of Demand or Estimated Milligrams E-cigarettes Purchased at Free Cost for Each Device Sampled

  60 minutes post puffing for 4 weeks

• Elasticity of Demand or Sensitivity to Price for Each Device Sampled

  60 minutes post puffing for 4 weeks

• Substitution Levels of Alternative Tobacco Products

  120 minutes post puffing for 4 weeks

Study Arms (14)

Product Sequence D

EXPERIMENTAL

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.

Device: Vaporizer Device; Drug: Salt-High Nicotine Tobacco Flavored (Product D)

Product Sequence A then B then C

EXPERIMENTAL

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.

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 D

EXPERIMENTAL

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.

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 C

EXPERIMENTAL

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.

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 A

EXPERIMENTAL

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.

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

EXPERIMENTAL

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.

Drug: Nicotine; Device: Vaporizer Device; Drug: Free-Low Nicotine Tobacco Flavored (Product C)

Product sequence D then C then B then A

EXPERIMENTAL

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.

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 C

EXPERIMENTAL

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.

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 B

EXPERIMENTAL

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.

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 B

EXPERIMENTAL

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.

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 B

EXPERIMENTAL

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.

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 C

EXPERIMENTAL

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.

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 C

EXPERIMENTAL

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.

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 A

EXPERIMENTAL

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.

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)

Interventions

Nicotine DRUG

Vape Free-Low nicotine unflavored

Also known as: Free-Low Nicotine Unflavored (Product A), NIC

Product Sequence A then B then C; Product Sequence A then B then D then C; Product sequence A then C; Product sequence A then C then D then B; Product sequence A then D then B then C; Product sequence B then A then D thn C; Product sequence B then C then A then D; Product sequence B then D then C then A; Product sequence C then D then A then B; Product sequence C then D then B then A; Product sequence D then A then C then B; Product sequence D then B then A then C; Product sequence D then C then B then A

Vaporizer Device DEVICE

Take puffs from vaporizer filled with different flavors

Also known as: Vaporizer

Product Sequence A then B then C; Product Sequence A then B then D then C; Product Sequence D; Product sequence A then C; Product sequence A then C then D then B; Product sequence A then D then B then C; Product sequence B then A then D thn C; Product sequence B then C then A then D; Product sequence B then D then C then A; Product sequence C then D then A then B; Product sequence C then D then B then A; Product sequence D then A then C then B; Product sequence D then B then A then C; Product sequence D then C then B then A

Salt-HIgh Nicotine Unflavored (Product B) DRUG

Vape Salt-High nicotine unflavored

Product Sequence A then B then C; Product Sequence A then B then D then C; Product sequence A then C then D then B; Product sequence A then D then B then C; Product sequence B then A then D thn C; Product sequence B then C then A then D; Product sequence B then D then C then A; Product sequence C then D then A then B; Product sequence C then D then B then A; Product sequence D then A then C then B; Product sequence D then B then A then C; Product sequence D then C then B then A

Free-Low Nicotine Tobacco Flavored (Product C) DRUG

Vape Free-Low Nicotine Tobacco

Product Sequence A then B then C; Product Sequence A then B then D then C; Product sequence A then C; Product sequence A then C then D then B; Product sequence A then D then B then C; Product sequence B then A then D thn C; Product sequence B then C then A then D; Product sequence B then D then C then A; Product sequence C then D then A then B; Product sequence C then D then B then A; Product sequence D then A then C then B; Product sequence D then B then A then C; Product sequence D then C then B then A

Salt-High Nicotine Tobacco Flavored (Product D) DRUG

Vape Salt-High Tobacco

Product Sequence A then B then D then C; Product Sequence D; Product sequence A then C then D then B; Product sequence A then D then B then C; Product sequence B then A then D thn C; Product sequence B then C then A then D; Product sequence B then D then C then A; Product sequence C then D then A then B; Product sequence C then D then B then A; Product sequence D then A then C then B; Product sequence D then B then A then C; Product sequence D then C then B then A

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine; Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Equipment and Supplies

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Comprehensive Cancer Center

Adrienne.Groman@RoswellPark.org

716-845-2300

Study Officials

• Amanda Quisenberry

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participant and researcher will be blinded to solution flavor and nicotine concentrates.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: February 18, 2020
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Locations

US (1)