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Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

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ClinicalTrials.gov Identifier: NCT03830892
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.

Condition or disease Intervention/treatment Phase
Electronic Cigarettes Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette Other: Own Brand Session - E-cigarette/Cigarette Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes.

All participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette.

The first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.

Masking: Single (Participant)
Masking Description: Participants will be blinded to their condition (power level and nicotine concentration) used in each session, except during their 'own brand' session.
Primary Purpose: Basic Science
Official Title: Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Active Comparator: E-cigarette User (Exclusive)
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine
E-cigarette paired with low nicotine, low device power

Other: E-cigarette Lab Session 15 watts, 30 mg nicotine
E-cigarette paired with low nicotine, low device power

Other: E-cigarette Lab Session 30 watts, 10 mg nicotine
E-cigarette paired with low nicotine, low device power

Other: E-cigarette Lab Session 30 watts, 30 mg nicotine
E-cigarette paired with low nicotine, low device power

Other: Own Brand Session - E-cigarette
E-cigarette paired with own brand liquid and preferred power

Active Comparator: Dual User
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine
E-cigarette paired with low nicotine, low device power

Other: E-cigarette Lab Session 15 watts, 30 mg nicotine
E-cigarette paired with low nicotine, low device power

Other: E-cigarette Lab Session 30 watts, 10 mg nicotine
E-cigarette paired with low nicotine, low device power

Other: E-cigarette Lab Session 30 watts, 30 mg nicotine
E-cigarette paired with low nicotine, low device power

Other: Own Brand Session - E-cigarette
E-cigarette paired with own brand liquid and preferred power

Other: Own Brand Session - E-cigarette/Cigarette
Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power




Primary Outcome Measures :
  1. Breakpoint of Drug Purchase Tasks (DPT) [ Time Frame: Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). ]
    The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.

  2. Breakpoint of Multiple Choice Procedure (MCP) [ Time Frame: Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). ]
    The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed).

  3. Effort for product puffs with the Progressive Ratio Task (PRT) [ Time Frame: Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). ]
    The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) through three outcome measures. 1) Breakpoint (maximum number of key presses completed to earn a puff), 2) number of puffs self-administrated, and 3) latency (seconds) to initiate key pressing.


Other Outcome Measures:
  1. Subjective measures of nicotine abstinence symptoms [ Time Frame: First measure given, regardless of task order, 90 minutes into each session ]
    Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.

  2. Subjective measures of nicotine abstinence symptoms [ Time Frame: Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). ]
    Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.

  3. Subjective measures of nicotine abstinence symptoms [ Time Frame: Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). ]
    Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.

  4. Subjective measures of nicotine abstinence symptoms [ Time Frame: Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). ]
    Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.

  5. Change in Heart Rate [ Time Frame: Recorded throughout each 4 hour study session using automated software every 10 seconds. ]
    Heart rate (measured in bpm)

  6. Change in Systolic Blood Pressure [ Time Frame: Recorded throughout each 4 hour study session using automated software every 5 minutes. ]
    Blood pressure (measured in mm)

  7. Change in Diastolic Blood Pressure [ Time Frame: Recorded throughout each 4 hour study session using automated software every 5 minutes. ]
    and blood pressure (measured in hg)



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:

  • healthy (determined by self-report)
  • between the ages of 21-55
  • willing to provide informed consent
  • able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

  • Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

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): NCT03830892


Contacts
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Contact: Caroline O Cobb, PhD 804-828-8687 cobbco@vcu.edu
Contact: Rebecca Lester-Scholtes, BS 804-828-1867 lesterrc@vcu.edu

Locations
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United States, Virginia
Center for the Study of Tobacco Products Recruiting
Richmond, Virginia, United States, 23220
Contact: Rebecca Lester Scholtes, B.S.    804-828-0401    bhrlvcu@gmail.com   
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Caroline Cobb (Amey), PhD Virginia Commonwealth University
Principal Investigator: Andrew Barnes, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03830892     History of Changes
Other Study ID Numbers: HM20012696
2U54DA036105 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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