Clinical trial NCT04231539: Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study
Official title: Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids[SALTVAPE Study]
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nicotine Dependence
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The participant and researcher will be blinded to solution flavor and nicotine concentrates.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum concentration of nicotine in plasma (Cmax)
timeFrame: Up to 1 year
measure: Area under the concentration-time curve (AUC)
timeFrame: From 0 to 120 minutes
measure: Time to maximum concentration
timeFrame: Up to 1 year
Secondary outcomes:
measure: Subjective measure of perceived harshness of nicotine withdrawal symptoms
timeFrame: Up to 1 year
measure: Subjective measure of perceived satisfaction of nicotine withdrawal symptoms
timeFrame: Up to 1 year
measure: Subjective measure of perceived liking of nicotine withdrawal symptoms
timeFrame: Up to 1 year
measure: Change in nicotine withdrawal symptoms
timeFrame: Up to 1 year
Other outcomes:
measure: Demand indices including intensity and elasticity of demand for each device sampled
timeFrame: Up to 1 year
measure: Substitution levels of alternative tobacco products
timeFrame: Up to 1 year
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Amanda Quisenberry
role: PRINCIPAL_INVESTIGATOR
References: