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Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Fruit Flavor, SALTVAPE Study

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ClinicalTrials.gov Identifier: NCT04231539
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This trial studies activity of time (pharmacokinetics), subjective effects, and abuse liability of nicotine salt-based vaping products with tobacco or fruit flavor. 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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Nicotine Device: Vaporizer Device Not Applicable

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 fruit) 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 fruit) 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 fruit flavor, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of fruit flavor, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The participant and researcher will be blinded to solution flavor and nicotine consentration.
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Fruit Flavor [SALTVAPE Study]
Actual Study Start Date : December 31, 2019
Estimated Primary Completion Date : December 22, 2020
Estimated Study Completion Date : December 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: Low Nicotine (nicotine vapor) 24 mg.ml
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 fruit flavor, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of fruit flavor, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.
Drug: Nicotine
Vape different flavor nicotine products
Other Names:
  • (-)-Nicotine
  • NIC

Device: Vaporizer Device
Take puffs from vaporizer filled with different flavors
Other Name: Vaporizer

Experimental: High Nicotine (nicotine vapor) 42 mg.ml
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 fruit flavor, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of fruit flavor, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.
Drug: Nicotine
Vape different flavor nicotine products
Other Names:
  • (-)-Nicotine
  • NIC

Device: Vaporizer Device
Take puffs from vaporizer filled with different flavors
Other Name: Vaporizer




Primary Outcome Measures :
  1. Maximum concentration of nicotine in plasma (Cmax) [ Time Frame: Up to 1 year ]
    Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus fruit), 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.

  2. Area under the concentration-time curve (AUC) [ Time Frame: From 0 to 120 minutes ]
    Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus fruit), 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.

  3. Time to maximum concentration [ Time Frame: Up to 1 year ]
    Each outcome will be modeled as a function of base (free-base versus salt based), flavor (tobacco versus fruit), 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 :
  1. Subjective measure of perceived harshness of nicotine withdrawal symptoms [ Time Frame: Up to 1 year ]
    A Sensory Measuring scale will be used with -100 least intense and 100 most intense.

  2. Subjective measure of perceived satisfaction of nicotine withdrawal symptoms [ Time Frame: Up to 1 year ]
    Product evaluation scale with 4 being most satisfying and 1 being least satisfying

  3. Subjective measure of perceived liking of nicotine withdrawal symptoms [ Time Frame: Up to 1 year ]
    Product evaluation scale with 4 being most satisfying and 1 being least satisfying

  4. Change in nicotine withdrawal symptoms [ Time Frame: Up to 1 year ]
    Minnesota Nicotine Withdrawal Scale


Other Outcome Measures:
  1. Demand indices including intensity and elasticity of demand for each device sampled [ Time Frame: Up to 1 year ]
    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.

  2. Substitution levels of alternative tobacco products [ Time Frame: Up to 1 year ]
    To compare the level of substitutability in the different product availability conditions, slopes will be compared using a 2 X 2 analysis of variance.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
    • Has a preference for tobacco and/or fruit flavored e-liquids
  • 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
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231539


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Amanda Quisenberry    716-845-4918    Amanda.Quisenberry@RoswellPark.org   
Principal Investigator: Amanda Quisenberry         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amanda Quisenberry Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04231539    
Other Study ID Numbers: I 475819
NCI-2019-07370 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 475819 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
U54CA228110 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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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
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action