Clinical trial NCT02500615: The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
Official title: The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Exposure
Nicotine Withdrawal Suppression
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-07-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Plasma nicotine concentration (ng/ml)
timeFrame: 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.
measure: Withdrawal suppression items on a visual analog scale
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Clinical Behavioral Pharmacology Laboratory
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Tory R Spindle, B.S.
role: PRINCIPAL_INVESTIGATOR
References: