NCT04231539

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]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Nicotine	Vape Free-Low nicotine unflavored
DEVICE	Vaporizer Device	Take puffs from vaporizer filled with different flavors
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
DRUG	Salt-High Nicotine Tobacco Flavored (Product D)	Vape Salt-High Tobacco

Timeline

• Start date: 2020-02-18
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2020-01-18
• Last updated: 2025-10-31
• Results posted: 2025-10-31

Locations

1 site across 1 country: United States