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Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

26. juli 2018 oppdatert av: John P. Richie, Milton S. Hershey Medical Center

Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers

The overall objectives of this clinical study are to determine in smokers the short term effects of switching to tobacco products that deliver low levels of nicotine or reactive oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke exposure and oxidative stress.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between 21-65 who smoke any of the following brands on a regular basis: Marlboro Red, Marlboro Menthol, Pall Mall Red, Pall Mall Menthol, Kool Menthol, Salem Menthol, L&M Menthol, Pyramid Red, Newport Red, Newport Menthol.

If you smoke one of these brand styles on a regular basis you may be eligible to participate in a compensated short term study on health and smoking behavior at Penn State Hershey Medical Center.

Study participation lasts 22 days, with 4 study visits at the Medical Center. Smokers are asked to use their usual brand for one week and then switch to 1 of 3 brands for the remaining two weeks. The three brands participants are randomly assigned to after the first week of participation are either Group 1. reduced nicotine content cigarette (Spectrum Research Cigarettes) or Group 2. reduced oxidant cigarette (American Spirit) or assigned to Group 3. usual brand. Whichever group you are assigned to, you will be asked to smoke only these until the end of the study. All cigarettes following visit 1 will be provided free of charge.

Study overview:

Visit 1/ Duration: 60 minutes Provide a blood and urine sample Complete a 20 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day

Visit 2: Randomized Phase /Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day

Visit 3/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day

Visit 4/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Sign compensation form

For information on additional tobacco studies being conducted at Penn State Hershey, please call 1-844-207-6392

*This research is being conducted under the investigator John Richie at Penn State Hershey; 500 University Drive Hershey, PA

Studietype

Intervensjonell

Registrering (Faktiske)

37

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater, 17033
        • Penn State Hershey

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

21 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age 21-65
  • Smoke 10 cigarettes/day or more for at least one year
  • Read and write in English
  • Menthol and nonmenthol smokers who use relatively high nicotine and ROS/RNS cigarettes
  • Able to understand and provide consent to study procedures
  • Plan to live in the local area for the next month
  • Women not pregnant or nursing and taking steps to avoid pregnancy
  • No quit attempt in the last one months and not planning to quit in the next month

Exclusion Criteria:

  • Currently pregnant or nursing
  • Unstable or significant medical condition, such as COPD or kidney failure, that is likely to affect biomarker data
  • Use of non-cigarette nicotine delivery product in the past week (included cigars, pipes, chew, snus, hookah, e-cig, and marijuana)
  • Currently reducing or planning to reduce cigarette consumption in the next month
  • Use of smoking cessation medicine in the past 3 months
  • History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
  • Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the last 6 months (substance abuse includes weekly, almost daily or daily use of other illegal drugs and prescription drugs that are not being used for medically prescribed purposes or alcohol abuse that would hinder the participant's ability to participate)
  • Significant medical condition, i.e. stroke, MI, cancer, in the last month
  • Currently using illegal drugs

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Reduced Nicotine Cigarettes
Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand.
Annen: Reduced Nicotine Cigarettes
Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Andre navn:
  • Cigarette contains .28mg (.29mg/menthol) of nicotine
Eksperimentell: Reduced ROS/RNS
Participants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes.
Annen: Reduced ROS/RNS
Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Andre navn:
  • Cigarette to be determined by lab experiment
Placebo komparator: Control Group
Participants will be assigned to continue smoking their usual brand of cigarettes.
Annen: Control
Human topography data will show if smokers change the way they smoke due to being in a research study. Select biosamples of participants will be used to analyze how biomarkers differ among groups

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Smoking Topography
Tidsramme: 8 days
measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument.
8 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Biomarkers of oxidative stress
Tidsramme: 4 times over the 22 day study period
biomarkers of oxidative stress are as followed: glutathionylated and cysteinylated proteins in blood and F2-isoprostanes and 8-hydroxydeoxyguanosine (8-OHdG).
4 times over the 22 day study period

Samarbeidspartnere og etterforskere

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

Sponsor

Milton S. Hershey Medical Center

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Food and Drug Administration (FDA)

Etterforskere

  • Hovedetterforsker: John Richie, Ph.D, Milton S. Hershey Medical Center

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 (Faktiske)

1. januar 2016

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først innsendt

9. april 2015

Først innsendt som oppfylte QC-kriteriene

9. april 2015

Først lagt ut (Anslag)

14. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juli 2018

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00001996
  • 5P50DA036107-02 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

At this time we have no plan for sharing, however if need should arise, then sharing may be a possibility.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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