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Completed

NCT Number: NCT02500615

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Behavioral Pharmacology Laboratory

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECIG liquid vehicles

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2015
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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