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

Phase 1

Completed

• Conditions: Nicotine Exposure; Nicotine Withdrawal Suppression
• Interventions: Other: ECIG liquid vehicles

• Registration Number: NCT02500615
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Study Start: 2016-07
• Primary Completion: 2017-05-16
• Study Completion: 2017-05-16
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 PG: 70 VG	ECIG liquid vehicles	-
100 PG: 0 VG	ECIG liquid vehicles	-
50 PG: 50 VG	ECIG liquid vehicles	-
0 PG: 100 VG	ECIG liquid vehicles	-
70 PG: 30 VG	ECIG liquid vehicles	-

Primary Outcome Measures

Name	Time	Method
Plasma nicotine concentration (ng/ml)	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	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

Trial Locations

Locations (1)

Clinical Behavioral Pharmacology Laboratory; 🇺🇸 Richmond, Virginia, United States