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

1. mai 2018 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

41

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Virginia
      • Richmond, Virginia, Forente stater, 23298
        • Clinical Behavioral Pharmacology Laboratory

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 0 PG: 100 VG
Annen: 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.
Eksperimentell: 30 PG: 70 VG
Annen: 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.
Eksperimentell: 50 PG: 50 VG
Annen: 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.
Eksperimentell: 70 PG: 30 VG
Annen: 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.
Eksperimentell: 100 PG: 0 VG
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plasma nicotine concentration (ng/ml)
Tidsramme: 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
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
Tidsramme: 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
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Virginia Commonwealth University

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Etterforskere

  • Hovedetterforsker: Tory R Spindle, B.S., Virginia Commonwealth University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2016

Primær fullføring (Faktiske)

16. mai 2017

Studiet fullført (Faktiske)

16. mai 2017

Datoer for studieregistrering

Først innsendt

6. juli 2015

Først innsendt som oppfylte QC-kriteriene

14. juli 2015

Først lagt ut (Anslag)

16. juli 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HM20004850
  • 1F31DA040319-01 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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