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.

Study Overview

• Status: Completed
• Conditions: Nicotine Exposure; Nicotine Withdrawal Suppression
• Intervention / Treatment: Other: ECIG liquid vehicles

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: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Clinical Behavioral Pharmacology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma nicotine concentration (ng/ml)	taken via intravenous catheter	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.
Withdrawal suppression items on a visual analog scale	provided using computerized questionnaire	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.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Tory R Spindle, B.S., Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): May 16, 2017
• Study Completion (Actual): May 16, 2017

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HM20004850; 1F31DA040319-01 (U.S. NIH Grant/Contract)