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- Klinische proef NCT02301325
Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15260
- University of Pittsburgh
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age 18+
- Smoke an average of at least five cigarettes per day for the last year with no periods of continuous abstinence longer than 30 days.
- Breath CO levels > or = 10 ppm (if < 10 ppm, then NicAlert Strip = 6)
- Fulfills need for participants in the required strata (menthol status)
Exclusion Criteria:
- Intention to quit smoking in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
- Significant prior adverse reaction to nicotine replacement as determined by the licensed medical professional.
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products 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)
- Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional)
- Schizophrenia and schizoaffective disorder
Positive toxicology screen for any of the following drugs: marijuana, cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
- Participants with valid prescriptions for any toxicology results will not be excluded.
- Breath alcohol level > 0.01
- Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period (female/male))
- Pregnant, trying to become pregnant or breastfeeding
- Smoking 'roll your own cigarettes' exclusively
Currently taking any one of the following medications:
- Phenytoin [Brand Name: Dilantin]
- Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]
- Oxcarbazepine [Brand Name: Trileptal]
- Primidone [Brand Name: Mysoline]
- Phenobarbital
- Bendamustine [Brand Name: Treanda]
- Clopidogrel [Brand Name: Plavix]
- Clozapine [Brand Name: Clozaril, FazaClo]
- Erlotinib [Brand Name: Tarceva]
- Flecainide [Brand Name: Tambocor]
- Fluvoxamine [Brand Name: Luvox]
- Irinotecan [Brand Name: Camptosar]
- Olanzapine [Brand Name: Zyprexa]
- Ropinirole [Brand Name: Requip]
- Tacrine [Brand Name: Cognex]
- Theophylline [Brand Name: Theo Dur]
- Estradiol
- CO reading >80 ppm
Systolic BP greater than or equal to 160
- Participants failing for blood pressure will be allowed to re-screen once.
Diastolic BP greater than or equal to 100
- Participants failing for blood pressure will be allowed to re-screen once.
Systolic BP below 90
- Participants failing for blood pressure will be allowed to re-screen once.
Diastolic BP below 50
- Participants failing for blood pressure will be allowed to re-screen once.
Heart rate greater than or equal to 105 bpm
- Participants failing for heart rate will be allowed to re-screen once.
Heart rate lower than 45 bpm
- Participants failing for heart rate will be allowed to re-screen once.
- Indicating any suicidal ideation in the past month or suicide attempts in the past 5 years (if within the past 6-10 years, LMP approval required).
- Inability to independently read and comprehend the consent form and other written study materials and measures.
Having participated in a research study during the past three months in which the participant:
- Smoked a cigarette that was not his/her usual brand cigarette for more than one day
- Used any tobacco products beyond normal use for more than one day
- Used any nicotine replacement products or smoking cessation medications for more than one day
- Having participated in Project 1, Study 1 (PRO11060292)
- Having participated in Project 1, Study 1C (PRO14040384)
- Household member enrolled in the study concurrently
- Significant prior adverse reactions to adhesives or latex
- Participant has a condition that interferes/does not allow for the collection of eligibility criteria
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 0.03 mg Nicotine Cigarette
Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes
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Ander: 0.03 mg Nicotine Cigarette and NRT
Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes and use nicotine replacement patches.
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Ander: 0.80 mg Nicotine Cigarette
Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes.
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Ander: 0.80 mg Nicotine Cigarette and NRT
Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes and use nicotine replacement patches.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Cigarettes Smoked Per Day
Tijdsspanne: Six Weeks
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Six Weeks
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Eric Donny, Ph.D., Professor, University of Pittsburgh
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- U54 DA031659-P1S2
- 1U54DA031659-01 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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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