The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
1 maj 2018 uppdaterad av: Virginia Commonwealth University
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
41
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Virginia
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Richmond, Virginia, Förenta staterna, 23298
- Clinical Behavioral Pharmacology Laboratory
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 0 PG: 100 VG
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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.
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Experimentell: 30 PG: 70 VG
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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.
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Experimentell: 50 PG: 50 VG
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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.
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Experimentell: 70 PG: 30 VG
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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.
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Experimentell: 100 PG: 0 VG
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Plasma nicotine concentration (ng/ml)
Tidsram: 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.
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taken via intravenous catheter
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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.
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Withdrawal suppression items on a visual analog scale
Tidsram: 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.
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provided using computerized questionnaire
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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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Tory R Spindle, B.S., Virginia Commonwealth University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2016
Primärt slutförande (Faktisk)
16 maj 2017
Avslutad studie (Faktisk)
16 maj 2017
Studieregistreringsdatum
Först inskickad
6 juli 2015
Först inskickad som uppfyllde QC-kriterierna
14 juli 2015
Första postat (Uppskatta)
16 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HM20004850
- 1F31DA040319-01 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .