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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

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date May 7, 2018
Study Start Date  ICMJE July 2016
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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
  • subjective responses [ 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
Official Title  ICMJE The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE
  • Nicotine Exposure
  • Nicotine Withdrawal Suppression
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 0 PG: 100 VG
    Intervention: Other: ECIG liquid vehicles
  • Experimental: 30 PG: 70 VG
    Intervention: Other: ECIG liquid vehicles
  • Experimental: 50 PG: 50 VG
    Intervention: Other: ECIG liquid vehicles
  • Experimental: 70 PG: 30 VG
    Intervention: Other: ECIG liquid vehicles
  • Experimental: 100 PG: 0 VG
    Intervention: Other: ECIG liquid vehicles
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2017)
41
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
75
Actual Study Completion Date  ICMJE May 16, 2017
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02500615
Other Study ID Numbers  ICMJE HM20004850
1F31DA040319-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Tory R Spindle, B.S. Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP