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The Effect of Electronic Cigarette Liquid Characteristics in Smokers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861078
Recruitment Status : Not yet recruiting
First Posted : March 4, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The purpose of this study is to determine differences in nicotine delivery, user behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of cigarettes.

Condition or disease Intervention/treatment Phase
Electronic Cigarettes Other: Own Brand Cigarette Other: ECIG 6 mg nicotine, sweetened Other: ECIG 6 mg nicotine, unsweet Other: ECIG 0 mg nicotine, sweetened Other: ECIG 0 mg nicotine, unsweet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Active Comparator: Own brand cigarette use
During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Other: Own Brand Cigarette
Effects of own brand cigarette use.

Experimental: ECIG 6 mg nicotine, sweetened
During each session, participants will complete a 10-puff product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Other: ECIG 6 mg nicotine, sweetened
Effects of using a 30 Watt ECIG filled with 6 mg nicotine, sweetened liquid

Experimental: ECIG 6 mg nicotine, unsweetened
During each session, participants will complete a 10-puff product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Other: ECIG 6 mg nicotine, unsweet
Effects of using a 30 Watt ECIG filled with 6 mg nicotine, unsweet liquid

Experimental: ECIG 0 mg nicotine, sweetened
During each session, participants will complete a 10-puff product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Other: ECIG 0 mg nicotine, sweetened
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid

Experimental: ECIG 0 mg nicotine, unsweetened
During each session, participants will complete a 10-puff product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Other: ECIG 0 mg nicotine, unsweet
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid




Primary Outcome Measures :
  1. Plasma Nicotine Concentration [ Time Frame: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes). ]
    Change in plasma nicotine concentration.

  2. Progressive Ratio Task [ Time Frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. ]
    The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing.


Secondary Outcome Measures :
  1. Hughes-Hatsukami Questionnaire [ Time Frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) ]
    This scale will be used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0-100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.

  2. Profile of Mood States scale [ Time Frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) ]
    This scale will be used to measure mood disturbance and consists of 30-items that are scored on a 5-point likert scale ranging from "not at all" to "extremely". The items from this scale are scored into six dimensions: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment.

  3. Drug Effects Questionnaire [ Time Frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) ]
    This questionnaire assess a respondent's feelings after recently using tobacco or nicotine products. It has a total of five items that participants rate from not at all to extremely scored 0-100. Each item is scored and analyzed separately (there are no sub-scales).

  4. Heart rate [ Time Frame: Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 minutes) ]
    Change in heart rate, measure in beats per minute.

  5. Puff volume [ Time Frame: Puff volume will be measured during the approximately 5-minute, 10-puff use bout. ]
    The volume of each puff, in ml.

  6. Puff Duration [ Time Frame: The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout. ]
    The duration of each puff, in seconds.

  7. Inter puff interval [ Time Frame: Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout. ]
    The time between each puff, in seconds.

  8. Flow rate [ Time Frame: Flow rate will be measured during the approximately 5-minute, 10-puff use bout. ]
    The rate of air flow during each puff, in ml/second.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria-- Participants must be:

  • Healthy (determined by self-report)
  • Between the ages of 18-55 years old
  • Current cigarette smokers
  • Wiling to provide informed consent
  • Able to attend the lab session and abstain from tobacco/nicotine products as required
  • Agree to use designated products according to the study protocol

Exclusion Criteria:

  • Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
  • Individuals who weigh less than 110 pounds.

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.


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): NCT03861078


Contacts
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Contact: Alison Breland, PhD 8046282300 abbrelan@vcu.edu
Contact: Thomas Eissenberg, PhD 804-827-3562 teissenb@vcu.edu

Locations
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United States, Virginia
Clinical Behavioral Pharmacology Laboratory Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Barbara Kilgalen, RN    804-827-3562      
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Investigators
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Study Director: Alison Breland, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03861078     History of Changes
Other Study ID Numbers: HM20015258
U54DA036105 ( U.S. NIH Grant/Contract )
F31DA047018 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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