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

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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Device: Vaporizer Device; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Drug: Nicotine; Drug: Salt-HIgh Nicotine Unflavored (Product B); Drug: Free-Low Nicotine Tobacco Flavored (Product C)

Detailed Description

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
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco
Experimental: 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.	Device: Vaporizer Device; Take puffs from vaporizer filled with different flavors; Other Names: Vaporizer; Drug: Salt-High Nicotine Tobacco Flavored (Product D); Vape Salt-High Tobacco; Drug: Nicotine; Vape Free-Low nicotine unflavored; Other Names: NIC; Free-Low Nicotine Unflavored (Product A); Drug: Salt-HIgh Nicotine Unflavored (Product B); Vape Salt-High nicotine unflavored; Drug: Free-Low Nicotine Tobacco Flavored (Product C); Vape Free-Low Nicotine Tobacco

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Harshness of Experimental Product Sampled	Subjective Measure of Perceived Harshness (Likert, 1-5: 1 = best outcome, 5 = worst outcome).	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.	120 minutes after session start on last session (session 4)
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.	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.	5 minutes pre puffing and 3 minutes post puffing for 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of Demand or Estimated Milligrams E-cigarettes Purchased at Free Cost for Each Device Sampled	Demand intensity is a behavioral economic estimated measure of consumption at zero cost in a experimental marketplace focused on purchasing of tobacco and nicotine products over increasing price of one product while others stay the same price. Participants were asked to purchase tobacco products (12 options) for one week's use. At each of the four sessions, participants experienced a marketplace with e-cigarette liquid prices of $1.63, $3.25, $6.50, and $13.00, while the prices of the other 11 tobacco products remained the same. Units purchased are transformed into mg of nicotine and nonlinear regression is used to estimate the purchasing when e-cigarettes are free/demand intensity, which is reported here. Higher scores indicate more mg of nicotine from e-cigarettes were purchased	60 minutes post puffing for 4 weeks
Elasticity of Demand or Sensitivity to Price for Each Device Sampled	Demand elasticity , or sensitivity to price, is a behavioral economic measure of of the rate of purchasing decline over increasing cost for e-cigarettes. At each of the four sessions, participants experienced a marketplace with e-cigarette liquid prices of $1.63, $3.25, $6.50, and $13.00, while the prices of the other 11 tobacco products remained the same. Units purchased are transformed into mg of nicotine and nonlinear regression is used to estimate the purchasing when e-cigarettes are free/demand intensity, which is reported here. Higher scores indicate more sensitivity to price, also called inelastic demand.	60 minutes post puffing for 4 weeks
Substitution Levels of Alternative Tobacco Products	Substitution is the slope of the line regressing consumption of the substitute product onto the price of cigarettes (cross-price elasticity). A positive coefficient indicates substitution (use of the substitute increases with increasing cigarette price). A negative value indicates complementarity (use of the substitute declines with increasing cigarette price). A value of 0 indicates no relationship.	120 minutes post puffing for 4 weeks

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Amanda Quisenberry, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkaloids; Equipment and Supplies; Solanaceous Alkaloids; Nicotine; Nebulizers and Vaporizers
• Other Study ID Numbers: I 475819 (Other Identifier: Roswell Park Cancer Institute); NCI-2019-07370 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U54CA228110 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes