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Project 2: Strategies for Reducing Nicotine Content in Cigarettes

13 agosto 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Anticipato)

1250

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Normal Nicotine Control Group
These subjects will smoke normal nicotine content Spectrum brand cigarettes for 20 weeks.
Comportamentale: Normal Nicotine Control Group
Participants will smoke experimental cigarettes for a period of 20-weeks.
Sperimentale: 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.
Comportamentale: Immediate Nicotine Reduction Group
Participants will smoke experimental cigarettes for a period of 20-weeks.
Sperimentale: 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.
Comportamentale: Gradual Nicotine Reduction Group
Participants will smoke experimental cigarettes for a period of 20-weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Toxicant exposure pattern: Expired air carbon monoxide
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Nicotine exposure: Total nicotine equivalents (TNE)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: End of treatment (Week 20)
Between group comparison of early termination from the study.
End of treatment (Week 20)
Measure of acceptability: Non-compliance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Wake Forest University Health Sciences

Collaboratori

National Institute on Drug Abuse (NIDA)

Investigatori

  • Investigatore principale: Eric Donny, PhD, University of Pittsburgh

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2014

Completamento primario (Effettivo)

1 marzo 2017

Completamento dello studio (Effettivo)

14 marzo 2017

Date di iscrizione allo studio

Primo inviato

12 maggio 2014

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2014

Primo Inserito (Stima)

16 maggio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 agosto 2018

Ultimo verificato

1 agosto 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • U54 DA031659-P2
  • U54DA031659 (Sovvenzione/contratto NIH degli Stati Uniti)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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