- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02139930
Project 2: Strategies for Reducing Nicotine Content in Cigarettes
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Arizona
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Phoenix, Arizona, États-Unis, 85054
- Mayo Clinic
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California
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San Francisco, California, États-Unis, 94143
- University of California San Francisco
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Florida
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Tampa, Florida, États-Unis, 33617
- Moffitt Cancer Center
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Maryland
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Baltimore, Maryland, États-Unis, 21224
- Johns Hopkins University
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Minnesota
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Duluth, Minnesota, États-Unis, 55812
- University of Minnesota Medical School Duluth
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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North Carolina
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Durham, North Carolina, États-Unis, 27705
- Duke University
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Oregon
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Eugene, Oregon, États-Unis, 97403
- Oregon Research Institute
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, États-Unis, 77030
- MDAnderson Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Toxicant exposure pattern: Expired air carbon monoxide
Délai: 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)
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Nicotine exposure: Total nicotine equivalents (TNE)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Eric Donny, PhD, University of Pittsburgh
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles induits chimiquement
- Troubles liés à une substance
- Trouble lié à l'usage du tabac
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agents cholinergiques
- Stimulants ganglionnaires
- Agonistes nicotiniques
- Agonistes cholinergiques
- Nicotine
Autres numéros d'identification d'étude
- U54 DA031659-P2
- U54DA031659 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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