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

Primary Purpose

Nicotine Dependence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine
Vaporizer Device
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nicotine Dependence

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Nicotine (nicotine vapor) 24 mg.ml

High Nicotine (nicotine vapor) 42 mg.ml

Arm Description

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 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.

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 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.

Outcomes

Primary Outcome Measures

Maximum concentration of nicotine in plasma (Cmax)
Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus unflavored), their interaction, prior combination indicator (for carry over effect), and a random subject effect using a linear mixed model. All model assumptions will be verified graphically and transformations will be applied as appropriate. The effect of "base" on the Cmax will be evaluated using tests about the least square means of "base". Additionally, 95% confidence intervals about the mean differences will be obtained.
Area under the concentration-time curve (AUC)
Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus unflavored), their interaction, prior combination indicator (for carry over effect), and a random subject effect using a linear mixed model. All model assumptions will be verified graphically and transformations will be applied as appropriate. The effect of "base" on the AUC nicotine will be evaluated using tests about the least square means of "base". Additionally, 95% confidence intervals about the mean differences will be obtained.
Time to maximum concentration
Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus unflavored), their interaction, prior combination indicator (for carry over effect), and a random subject effect using a linear mixed model. All model assumptions will be verified graphically and transformations will be applied as appropriate. The effect of "base" on the Tmax measures will be evaluated using tests about the least square means of "base". Additionally, 95% confidence intervals about the mean differences will be obtained.

Secondary Outcome Measures

Subjective measure of perceived harshness of nicotine withdrawal symptoms
A Sensory Measuring scale will be used with -100 least intense and 100 most intense.
Subjective measure of perceived satisfaction of nicotine withdrawal symptoms
Product evaluation scale with 4 being most satisfying and 1 being least satisfying
Subjective measure of perceived liking of nicotine withdrawal symptoms
Product evaluation scale with 4 being most satisfying and 1 being least satisfying
Change in nicotine withdrawal symptoms
Minnesota Nicotine Withdrawal Scale

Full Information

First Posted
January 10, 2020
Last Updated
June 6, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04231539
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
August 18, 2024 (Anticipated)
Study Completion Date
August 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The participant and researcher will be blinded to solution flavor and nicotine consentration.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Nicotine (nicotine vapor) 24 mg.ml
Arm Type
Experimental
Arm Description
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 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.
Arm Title
High Nicotine (nicotine vapor) 42 mg.ml
Arm Type
Experimental
Arm Description
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 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.
Intervention Type
Drug
Intervention Name(s)
Nicotine
Other Intervention Name(s)
(-)-Nicotine, NIC
Intervention Description
Vape different flavor nicotine products
Intervention Type
Device
Intervention Name(s)
Vaporizer Device
Other Intervention Name(s)
Vaporizer
Intervention Description
Take puffs from vaporizer filled with different flavors
Primary Outcome Measure Information:
Title
Maximum concentration of nicotine in plasma (Cmax)
Description
Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus unflavored), their interaction, prior combination indicator (for carry over effect), and a random subject effect using a linear mixed model. All model assumptions will be verified graphically and transformations will be applied as appropriate. The effect of "base" on the Cmax will be evaluated using tests about the least square means of "base". Additionally, 95% confidence intervals about the mean differences will be obtained.
Time Frame
Up to 1 year
Title
Area under the concentration-time curve (AUC)
Description
Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus unflavored), their interaction, prior combination indicator (for carry over effect), and a random subject effect using a linear mixed model. All model assumptions will be verified graphically and transformations will be applied as appropriate. The effect of "base" on the AUC nicotine will be evaluated using tests about the least square means of "base". Additionally, 95% confidence intervals about the mean differences will be obtained.
Time Frame
From 0 to 120 minutes
Title
Time to maximum concentration
Description
Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus unflavored), their interaction, prior combination indicator (for carry over effect), and a random subject effect using a linear mixed model. All model assumptions will be verified graphically and transformations will be applied as appropriate. The effect of "base" on the Tmax measures will be evaluated using tests about the least square means of "base". Additionally, 95% confidence intervals about the mean differences will be obtained.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Subjective measure of perceived harshness of nicotine withdrawal symptoms
Description
A Sensory Measuring scale will be used with -100 least intense and 100 most intense.
Time Frame
Up to 1 year
Title
Subjective measure of perceived satisfaction of nicotine withdrawal symptoms
Description
Product evaluation scale with 4 being most satisfying and 1 being least satisfying
Time Frame
Up to 1 year
Title
Subjective measure of perceived liking of nicotine withdrawal symptoms
Description
Product evaluation scale with 4 being most satisfying and 1 being least satisfying
Time Frame
Up to 1 year
Title
Change in nicotine withdrawal symptoms
Description
Minnesota Nicotine Withdrawal Scale
Time Frame
Up to 1 year
Other Pre-specified Outcome Measures:
Title
Demand indices including intensity and elasticity of demand for each device sampled
Description
First, to quantify the relationship between purchasing and the price of e-cigarettes, the data will be fit to a modification of a model proposed by Hursh and Silberberg. Then, to analyze the level of substitution of alternative tobacco products, we will fit linear regressions for each product type. Slopes that differ from zero will be considered substitutes within each product availability condition.
Time Frame
Up to 1 year
Title
Substitution levels of alternative tobacco products
Description
To compare the level of substitutability in the different product availability conditions, slopes will be compared using a 2 X 2 analysis of variance.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Quisenberry
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Quisenberry
Phone
716-845-4918
Email
Amanda.Quisenberry@RoswellPark.org
First Name & Middle Initial & Last Name & Degree
Amanda Quisenberry

12. IPD Sharing Statement

Learn more about this trial

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

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