- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01438944
Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction
Evaluation of Nicotine Receptor Up-regulation Activity Through Metabolic Induction and Changes in Responsiveness Using Surrogate Evaluation Methods
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Studies have shown that prolonged exposure to nicotine reinforces addiction. The act of smoking delivers nicotine through lungs into the blood stream. As a result, during smoking nicotine levels peak and then when smoking stops levels progressively diminish to a base (trough) level. At the peak level a smoker feels rewarded, but at the trough level a smoker starts to experience negative withdrawal affects and a desire to smoke. Nicotine Gum and Inhalers mimic this smoking behaviour maintaining a peak and trough regime, but nicotine patches do not. Instead, nicotine patches deliver a constant base dose considered to be either above that of the smokers trough level or at a level where negative withdrawal effects are reduced.
The question arises as to if nicotine levels delivered by a patch are constant and potentially above that of the baseline smokers level, does this reinforce the addiction and therefore contribute to the high long term relapse rate? To answer this question the investigators will be looking at metabolites which the body uses to breakdown nicotine and several other enzymes. These metabolites respond to the levels of nicotine in the blood stream by increasing or decreasing over time. By testing blood flow, blood and urine the investigators are able to gain an insight into how the body is dealing with a constant stable dose of nicotine rather than a peak and trough dose. In combination with the questionnaires the investigators will be able to determine the level of affect.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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South Australia
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Adelaide, South Australia, Australie, 5044
- Kristin Carson
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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:
- Smokers who currently smoke at least 10 cigarettes per day
- Aged between 18 and 75
- Informed consent
- Willingness to attempt to quit smoking for the period specified, initially with a transdermal patch for 14 days and then without any smoking cessation aids for a further 14 days.
Exclusion Criteria:
- Use of bupropion, champix or nicotine containing products other than cigarettes in the last 2 months
- previous reactions to NRT
- Pregnancy / Breast Feeding
- Uncontrolled hypertension
- Unstable angina
- Heart attack or stroke within the previous 6 months
- Severe Obesity as indicated by Body Mass Index (BMI) ≥35 (potential for slow release of nicotine from tissues)
- acute psychiatric illness, past history psychosis, suicidal ideation or current diminished capacity.
- Current treatment or recent diagnosis of cancer
- Current use of Phenobarbital or other anticonvulsant drugs (induction of metabolism of nicotine to cotinine)
- Renal failure (creatinine clearance<30ml/min - reduces metabolic clearance of cotinine and nicotine)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: Nicabate 21mg transdermal NRT
21mg Transdermal NRT applied for 24hrs over a 14day period.
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Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline Nicotine, cotinine, Leptin and orexin Metabolite ratios
Délai: Baseline, Day 4, Day 14 and Day 28
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Baseline Prior to Transdermal NRT patch application Day 4 NRT Patch Application Day 14 Last Day NRT Patch Application Day 28 14 Days post NRT patch removal.
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Baseline, Day 4, Day 14 and Day 28
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline Patient Instruments: Fagerstrom Test for Nicotine Dependence (FTND), Wisconsin Smoking Withdrawal Scale (WSWS), Michigan Nicotine Reinforcement Questionnaire (MNRQ), Smoker Diary
Délai: Baseline, Day 14 and Day 28
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Comparative evaluation patient instruments with ratios of metabolite induction
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Baseline, Day 14 and Day 28
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Michael Roberts, BPharm PhD, University of Queeensland, University of South Australia
- Chercheur principal: Brian Smith, MBBS, PhD, Queen Elizabeth Hospital, University of Adelaide
- Chercheur principal: Thomas Robertson, PhD, Therapeutics Research Centre
- Chercheur principal: Micahel Ward, PhD, University of South Australia
- Chercheur principal: John Beltrame, MBBS, FRACP, Queen Elizabeth Hospital, University of Adelaide
- Chercheur principal: Malcolm Brinn, BHlthSc, Clinical Practice Unit
- Chercheur principal: Kritin Carson, PhD, Clinical Practice Unit
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
- Comportement compulsif
- Comportement impulsif
- Comportement, Addictif
- 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
- 2011039
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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