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The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500615
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
This study examines the acute effects in ECIG users of the two primary vehicles in ECIG liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid nicotine concentration, puff number, and interpuff interval all will be held constant). Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in each condition.

Condition or disease Intervention/treatment Phase
Nicotine Exposure Nicotine Withdrawal Suppression Other: ECIG liquid vehicles Phase 1

Detailed Description:
Electronic cigarettes (ECIGs) are among the most important issues in public health today due to their dramatic increase in popularity. However, very little is known about ECIGs, including what factors may make them more likely to be used and abused. Examining factors that influence nicotine yield, delivery, and subjective effects from ECIGs is essential to understanding their abuse liability. Limited pre-clinical research has revealed that nicotine yield may be influenced by the ratio of the two liquid vehicles, propylene glycol (PG) and vegetable glycerin (VG), most commonly found in ECIG solutions. Specifically, higher proportions of PG result in greater nicotine yields. However, the influence of PG:VG ratio on nicotine delivery and subjective effects associated with ECIG use has not been examined previously. The primary hypotheses are that higher proportions of PG will result in greater nicotine delivery and subjective effect profiles suggestive of higher abuse liability in ECIG users. Results from this project will result in further understanding of the factors that influence the abuse liability of ECIGs and could inform regulation of these products.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
Study Start Date : July 2016
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : May 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: 0 PG: 100 VG Other: ECIG liquid vehicles
The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.

Experimental: 30 PG: 70 VG Other: ECIG liquid vehicles
The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.

Experimental: 50 PG: 50 VG Other: ECIG liquid vehicles
The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.

Experimental: 70 PG: 30 VG Other: ECIG liquid vehicles
The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.

Experimental: 100 PG: 0 VG Other: ECIG liquid vehicles
The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.




Primary Outcome Measures :
  1. Plasma nicotine concentration (ng/ml) [ Time Frame: Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long. ]
    taken via intravenous catheter

  2. Withdrawal suppression items on a visual analog scale [ Time Frame: Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long. ]
    provided using computerized questionnaire



Information from the National Library of Medicine

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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 use ≥1 ml of ECIG solution daily
  • Must use ECIG solution with a nicotine concentration ≥12 mg/ml
  • Must have used an ECIG for ≥3 months
  • Must be willing to abstain from nicotine and tobacco products for ≥12 hours prior to each session.

Exclusion Criteria:

  • History of chronic disease or psychiatric condition
  • Regular use of a prescription medication
  • Marijuana use >10 and alcohol use >25 days in the past 30
  • Any other illicit drug use (e.g., cocaine, opioids) in the past 30 days.
  • Positive test for pregnancy (by urinalysis)
  • Daily use of >5 conventional tobacco cigarettes

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): NCT02500615


Locations
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United States, Virginia
Clinical Behavioral Pharmacology Laboratory
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Tory R Spindle, B.S. Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02500615    
Other Study ID Numbers: HM20004850
1F31DA040319-01 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018