- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02139930
Project 2: Strategies for Reducing Nicotine Content in Cigarettes
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic
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California
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San Francisco, California, Forenede Stater, 94143
- University of California San Francisco
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Florida
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Tampa, Florida, Forenede Stater, 33617
- Moffitt Cancer Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Johns Hopkins University
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55812
- University of Minnesota Medical School Duluth
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota
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North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- Duke University
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Oregon
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Eugene, Oregon, Forenede Stater, 97403
- Oregon Research Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, Forenede Stater, 77030
- MDAnderson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Toxicant exposure pattern: Expired air carbon monoxide
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Nicotine exposure: Total nicotine equivalents (TNE)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Eric Donny, PhD, University of Pittsburgh
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Stof-relaterede lidelser
- Tobaksbrugsforstyrrelse
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Ganglionstimulerende midler
- Nikotiniske agonister
- Kolinerge agonister
- Nikotin
Andre undersøgelses-id-numre
- U54 DA031659-P2
- U54DA031659 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Normal Nicotine Control Group
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Duke UniversityNational Institute of Nursing Research (NINR); National Institutes of Health...Aktiv, ikke rekrutterendeKroniske nyresygdomme | Diabetes mellitus, type 1 | Systemisk lupus erythematosus | Inflammatoriske tarmsygdomme | Cystisk fibrose | Seglcellesygdom | Stamcelletransplantation | Barnekræft | OrgantransplantationForenede Stater
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Bright Cloud International CorpNational Cancer Institute (NCI); Rutgers, The State University of New JerseyRekrutteringKognitiv svækkelse, mildForenede Stater
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The University of Texas Health Science Center,...RekrutteringDynaCleft®-effekter på blødt væv og på livskvalitet for spædbørn med ufuldstændig ensidig læbespalteLæbe- og ganespalteForenede Stater
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National Institute of Diabetes and Digestive and...Detroit Department of HealthAfsluttet
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Federico II UniversityAfsluttetSund og rask | Overvægt og fedmeItalien
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University of California, San FranciscoMount Zion Health Fund; Pritzker Family Foundation; Mental Insight FoundationAfsluttetDepression, UnipolarForenede Stater
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Johns Hopkins Bloomberg School of Public HealthNative American Research Centers for Health (NARCH)AfsluttetDepressive symptomer | StofbrugForenede Stater
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University of ParmaAfsluttetMotorisk aktivitet | Hemiplegisk cerebral pareseItalien
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University of MichiganAfsluttetForældreskabForenede Stater
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University of ArkansasTrukket tilbageMeibomisk kirtel dysfunktionForenede Stater