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Project 2: Strategies for Reducing Nicotine Content in Cigarettes

13 augustus 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

1250

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Normal Nicotine Control Group
These subjects will smoke normal nicotine content Spectrum brand cigarettes for 20 weeks.
Gedragsmatig: Normal Nicotine Control Group
Participants will smoke experimental cigarettes for a period of 20-weeks.
Experimenteel: 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.
Gedragsmatig: Immediate Nicotine Reduction Group
Participants will smoke experimental cigarettes for a period of 20-weeks.
Experimenteel: 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.
Gedragsmatig: Gradual Nicotine Reduction Group
Participants will smoke experimental cigarettes for a period of 20-weeks.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Toxicant exposure pattern: Expired air carbon monoxide
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Nicotine exposure: Total nicotine equivalents (TNE)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: End of treatment (Week 20)
Between group comparison of early termination from the study.
End of treatment (Week 20)
Measure of acceptability: Non-compliance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Medewerkers

National Institute on Drug Abuse (NIDA)

Onderzoekers

  • Hoofdonderzoeker: Eric Donny, PhD, University of Pittsburgh

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2014

Primaire voltooiing (Werkelijk)

1 maart 2017

Studie voltooiing (Werkelijk)

14 maart 2017

Studieregistratiedata

Eerst ingediend

12 mei 2014

Eerst ingediend dat voldeed aan de QC-criteria

13 mei 2014

Eerst geplaatst (Schatting)

16 mei 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 augustus 2018

Laatste update ingediend die voldeed aan QC-criteria

13 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • U54 DA031659-P2
  • U54DA031659 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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