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Project 2: Strategies for Reducing Nicotine Content in Cigarettes

13. august 2018 oppdatert av: Wake Forest University Health Sciences
The main goal of this project is to compare two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels or a gradual reduction in nicotine content in cigarettes to non-addictive levels. These two approaches will then be contrasted to a group that continues to smoke cigarettes with nicotine content similar to conventional cigarettes.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This project will be conducted to compare product use patterns and biomarkers of exposure between smokers who are assigned to a) gradual reduction in reduced nicotine content (RNC) cigarettes; b) immediate reduction to very low nicotine content (VLNC) cigarettes or c) normal nicotine content (NNC) cigarettes. The outcomes from this study will provide information on different approaches to reducing levels of nicotine in cigarettes and will determine the approach with the most optimal outcomes taking into account the balance between overall risk reduction (possibly maximized by abrupt switching) and compliance and acceptability (possibly maximized by gradual reduction of RNC cigarettes).

Studietype

Intervensjonell

Registrering (Forventet)

1250

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
    • Arizona
      • Phoenix, Arizona, Forente stater, 85054
        • Mayo Clinic
    • California
      • San Francisco, California, Forente stater, 94143
        • University of California San Francisco
    • Florida
      • Tampa, Florida, Forente stater, 33617
        • Moffitt Cancer Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • Johns Hopkins University
    • Minnesota
      • Duluth, Minnesota, Forente stater, 55812
        • University of Minnesota Medical School Duluth
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
        • Duke University
    • Oregon
      • Eugene, Oregon, Forente stater, 97403
        • Oregon Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, Forente stater, 77030
        • MDAnderson Cancer Center

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 18+
  2. Daily smokers who smoke an average of at least five cigarettes per day for at least 1 year
  3. Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip level must indicate regular smoking)

Exclusion Criteria:

  1. Planned quit date in the next 30 days
  2. Currently seeking treatment for smoking cessation
  3. Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (non-cessation intermittent use acceptable)
  4. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
  5. Using other tobacco products or e-cigarettes more than 9 days in the past 30 days
  6. Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site)
  7. Unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site)
  8. Schizophrenia and schizoaffective disorder
  9. Psychiatric medication changes (e.g., new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms.

  10. Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP

    1. Marijuana will be tested for but will not be an exclusionary criterion.
    2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
    3. Participants failing the toxicology screen will be allowed to re-screen once.

  11. Blood alcohol level > 0.01

    a. Participants failing the blood alcohol screen will be allowed to re-screen once.

  12. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks per day (female/male))
  13. Pregnant, trying to become pregnant or breastfeeding
  14. Predominant use of 'roll your own cigarettes'
  15. CO reading >80 ppm

  16. Systolic BP greater than or equal to 160

    a. Participants failing for blood pressure will be allowed to re-screen once.

  17. Diastolic BP greater than or equal to 100

    a. Participants failing for blood pressure will be allowed to re-screen once.

  18. Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)

    a. Participants failing for blood pressure will be allowed to re-screen once.

  19. Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)

    a. Participants failing for blood pressure will be allowed to re-screen once.

  20. Heart rate greater than or equal to 105 bpm

    a. Participants failing for heart rate will be allowed to re-screen once.

  21. Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)

    a. Participants failing for heart rate will be allowed to re-screen once.

  22. Indicating any suicidal ideation in the past month, suicide attempts in the past 5 years (if within past 5 to 10 years, requires physician approval), or score of >4 on the MINI suicide subscale
  23. Household member enrolled in the study concurrently.
  24. Inability to independently read and comprehend the consent form and other written study materials and measures because participants are required to complete parts of the protocol at home independently.
  25. Participated in prior study that involved reduced nicotine content cigarettes.
  26. Having participated in a research study during the past three months in a study that would impact baseline smoking or response to study products.

  27. Currently taking the following anticonvulsant medications:

    1. Phenytoin [Brand Name: Dilantin]
    2. Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]
    3. Oxcarbazepine [Brand Name: Trileptal]
    4. Primidone [Brand Name: Mysoline]
    5. Phenobarbital

  28. Currently taking the following medication:

    1. Bendamustine (Treanda)
    2. Clopidogrel (Plavix)
    3. Clozapine (Clozaril, FazaClo)
    4. Erlotinib (Tarceva)
    5. Flecainide (Tambocor)
    6. Fluvoxamine (Luvox)
    7. Irinotecan (Camptosar)
    8. Olanzapine (Zyprexa)
    9. Ropinirole (Requip)
    10. Tacrine (Cognex)
    11. Theophylline (Theo Dur, etc.)

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
Aktiv komparator: Normal Nicotine Control Group
These subjects will smoke normal nicotine content Spectrum brand cigarettes for 20 weeks.
Atferdsmessig: Normal Nicotine Control Group
Participants will smoke experimental cigarettes for a period of 20-weeks.
Eksperimentell: Immediate Nicotine Reduction Group
This group will immediately be switched to smoking very low nicotine content (VLNC) Spectrum brand cigarettes. They will smoke these cigarettes for 20 weeks.
Atferdsmessig: Immediate Nicotine Reduction Group
Participants will smoke experimental cigarettes for a period of 20-weeks.
Eksperimentell: Gradual Nicotine Reduction Group
This group will smoke progressively lower nicotine content Spectrum brand cigarettes for a period of one month each until they end up smoking the same VLNC cigarettes as the immediate reduction group.
Atferdsmessig: Gradual Nicotine Reduction Group
Participants will smoke experimental cigarettes for a period of 20-weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Toxicant exposure pattern: Expired air carbon monoxide
Tidsramme: 20-week treatment period
Between group comparison of expired air carbon monoxide (CO) values at week 20 using baseline CO values as a covariate.
20-week treatment period
Toxicant exposure pattern: Urinary phenanthrene tetroal (Phe)
Tidsramme: 20-week treatment period
Between group comparison of urinary phenanthrene tetroal values at week 20 using baseline values as a covariate.
20-week treatment period
Toxicant exposure pattern: Urinary mercapturic acids of acrolein
Tidsramme: 20-week treatment period
Between group comparison of urinary mercapturic acid level at week 20 using baseline values as a covariate.
20-week treatment period

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Nicotine exposure: Total nicotine equivalents (TNE)
Tidsramme: End of treatment (Week 20)
Between group comparison of urinary total nicotine equivalents at week 20 using baseline values as a covariate.
End of treatment (Week 20)
Other toxicant exposure: Tobacco specific nitrosamines-Total NNAL and NNN
Tidsramme: End of treatment (Week 20)
Between group comparison of urinary total NNAL and NNN levels at week 20 using baseline values as a covariate.
End of treatment (Week 20)
Effect biomarker: C-Reactive protein-high sensitivity as an inflammation biomarker
Tidsramme: End of treatment (Week 20)
Between group comparison of C-Reactive protein levels in serum at week 20 using baseline values as a covariate.
End of treatment (Week 20)
Measure of acceptability: Retention in study
Tidsramme: End of treatment (Week 20)
Between group comparison of early termination from the study.
End of treatment (Week 20)
Measure of acceptability: Non-compliance
Tidsramme: End of treatment (Week 20)
Between group comparison of use of non-study tobacco products.
End of treatment (Week 20)
Effect biomarker: 8-epi-PGF2α as a biomarker for oxidative stress
Tidsramme: End of treatment (Week 20)
Between group comparison of 8-epi-PGF2α at week 20 using baseline values as a covariate.
End of treatment (Week 20)
Effect biomarker: White blood cells count as inflammation biomarker
Tidsramme: End of treatment (Week 20)
Between group comparison of white blood cell count at week 20 using baseline values as a covariate.
End of treatment (Week 20)
Nicotine exposure: Urinary cotinine
Tidsramme: End of treatment (Week 20)
Between group comparison of urinary total nicotine equivalents at week 20 using baseline values as a covariate.
End of treatment (Week 20)

Samarbeidspartnere og etterforskere

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

Sponsor

Wake Forest University Health Sciences

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Etterforskere

  • Hovedetterforsker: Eric Donny, PhD, University of Pittsburgh

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. september 2014

Primær fullføring (Faktiske)

1. mars 2017

Studiet fullført (Faktiske)

14. mars 2017

Datoer for studieregistrering

Først innsendt

12. mai 2014

Først innsendt som oppfylte QC-kriteriene

13. mai 2014

Først lagt ut (Anslag)

16. mai 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • U54 DA031659-P2
  • U54DA031659 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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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