- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02139930
Project 2: Strategies for Reducing Nicotine Content in Cigarettes
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85054
- Mayo Clinic
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California
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San Francisco, California, Vereinigte Staaten, 94143
- University of California San Francisco
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Florida
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Tampa, Florida, Vereinigte Staaten, 33617
- Moffitt Cancer Center
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21224
- Johns Hopkins University
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Minnesota
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Duluth, Minnesota, Vereinigte Staaten, 55812
- University of Minnesota Medical School Duluth
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Minneapolis, Minnesota, Vereinigte Staaten, 55455
- University of Minnesota
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27705
- Duke University
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Oregon
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Eugene, Oregon, Vereinigte Staaten, 97403
- Oregon Research Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- MDAnderson Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 18+
- Daily smokers who smoke an average of at least five cigarettes per day for at least 1 year
- Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip level must indicate regular smoking)
Exclusion Criteria:
- Planned quit date in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (non-cessation intermittent use acceptable)
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products or e-cigarettes more than 9 days in the past 30 days
- 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)
- Unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site)
- Schizophrenia and schizoaffective disorder
- 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.
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
- Marijuana will be tested for but will not be an exclusionary criterion.
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
- Participants failing the toxicology screen will be allowed to re-screen once.
Blood alcohol level > 0.01
a. Participants failing the blood alcohol screen will be allowed to re-screen once.
- Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks per day (female/male))
- Pregnant, trying to become pregnant or breastfeeding
- Predominant use of 'roll your own cigarettes'
- CO reading >80 ppm
Systolic BP greater than or equal to 160
a. Participants failing for blood pressure will be allowed to re-screen once.
Diastolic BP greater than or equal to 100
a. Participants failing for blood pressure will be allowed to re-screen once.
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.
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.
Heart rate greater than or equal to 105 bpm
a. Participants failing for heart rate will be allowed to re-screen once.
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.
- 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
- Household member enrolled in the study concurrently.
- 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.
- Participated in prior study that involved reduced nicotine content cigarettes.
- Having participated in a research study during the past three months in a study that would impact baseline smoking or response to study products.
Currently taking the following anticonvulsant medications:
- Phenytoin [Brand Name: Dilantin]
- Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]
- Oxcarbazepine [Brand Name: Trileptal]
- Primidone [Brand Name: Mysoline]
- Phenobarbital
Currently taking the following medication:
- Bendamustine (Treanda)
- Clopidogrel (Plavix)
- Clozapine (Clozaril, FazaClo)
- Erlotinib (Tarceva)
- Flecainide (Tambocor)
- Fluvoxamine (Luvox)
- Irinotecan (Camptosar)
- Olanzapine (Zyprexa)
- Ropinirole (Requip)
- Tacrine (Cognex)
- Theophylline (Theo Dur, etc.)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Normal Nicotine Control Group
These subjects will smoke normal nicotine content Spectrum brand cigarettes for 20 weeks.
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Participants will smoke experimental cigarettes for a period of 20-weeks.
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Experimental: 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.
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Participants will smoke experimental cigarettes for a period of 20-weeks.
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Experimental: 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.
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Participants will smoke experimental cigarettes for a period of 20-weeks.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Toxicant exposure pattern: Expired air carbon monoxide
Zeitfenster: 20-week treatment period
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Between group comparison of expired air carbon monoxide (CO) values at week 20 using baseline CO values as a covariate.
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20-week treatment period
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Toxicant exposure pattern: Urinary phenanthrene tetroal (Phe)
Zeitfenster: 20-week treatment period
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Between group comparison of urinary phenanthrene tetroal values at week 20 using baseline values as a covariate.
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20-week treatment period
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Toxicant exposure pattern: Urinary mercapturic acids of acrolein
Zeitfenster: 20-week treatment period
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Between group comparison of urinary mercapturic acid level at week 20 using baseline values as a covariate.
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20-week treatment period
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Nicotine exposure: Total nicotine equivalents (TNE)
Zeitfenster: End of treatment (Week 20)
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Between group comparison of urinary total nicotine equivalents at week 20 using baseline values as a covariate.
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End of treatment (Week 20)
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Other toxicant exposure: Tobacco specific nitrosamines-Total NNAL and NNN
Zeitfenster: End of treatment (Week 20)
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Between group comparison of urinary total NNAL and NNN levels at week 20 using baseline values as a covariate.
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End of treatment (Week 20)
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Effect biomarker: C-Reactive protein-high sensitivity as an inflammation biomarker
Zeitfenster: End of treatment (Week 20)
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Between group comparison of C-Reactive protein levels in serum at week 20 using baseline values as a covariate.
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End of treatment (Week 20)
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Measure of acceptability: Retention in study
Zeitfenster: End of treatment (Week 20)
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Between group comparison of early termination from the study.
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End of treatment (Week 20)
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Measure of acceptability: Non-compliance
Zeitfenster: End of treatment (Week 20)
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Between group comparison of use of non-study tobacco products.
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End of treatment (Week 20)
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Effect biomarker: 8-epi-PGF2α as a biomarker for oxidative stress
Zeitfenster: End of treatment (Week 20)
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Between group comparison of 8-epi-PGF2α at week 20 using baseline values as a covariate.
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End of treatment (Week 20)
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Effect biomarker: White blood cells count as inflammation biomarker
Zeitfenster: End of treatment (Week 20)
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Between group comparison of white blood cell count at week 20 using baseline values as a covariate.
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End of treatment (Week 20)
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Nicotine exposure: Urinary cotinine
Zeitfenster: End of treatment (Week 20)
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Between group comparison of urinary total nicotine equivalents at week 20 using baseline values as a covariate.
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End of treatment (Week 20)
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Eric Donny, PhD, University of Pittsburgh
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Chemisch induzierte Störungen
- Substanzbezogene Störungen
- Tabakkonsumstörung
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Autonome Agenten
- Agenten des peripheren Nervensystems
- Cholinerge Wirkstoffe
- Ganglionäre Stimulanzien
- Nikotin-Agonisten
- Cholinerge Agonisten
- Nikotin
Andere Studien-ID-Nummern
- U54 DA031659-P2
- U54DA031659 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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