- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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South Australia
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Adelaide, South Australia, Australien, 5044
- Kristin Carson
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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:
- 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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline Nicotine, cotinine, Leptin and orexin Metabolite ratios
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline Patient Instruments: Fagerstrom Test for Nicotine Dependence (FTND), Wisconsin Smoking Withdrawal Scale (WSWS), Michigan Nicotine Reinforcement Questionnaire (MNRQ), Smoker Diary
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael Roberts, BPharm PhD, University of Queeensland, University of South Australia
- Ledende efterforsker: Brian Smith, MBBS, PhD, Queen Elizabeth Hospital, University of Adelaide
- Ledende efterforsker: Thomas Robertson, PhD, Therapeutics Research Centre
- Ledende efterforsker: Micahel Ward, PhD, University of South Australia
- Ledende efterforsker: John Beltrame, MBBS, FRACP, Queen Elizabeth Hospital, University of Adelaide
- Ledende efterforsker: Malcolm Brinn, BHlthSc, Clinical Practice Unit
- Ledende efterforsker: Kritin Carson, PhD, Clinical Practice Unit
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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
- Kompulsiv adfærd
- Impulsiv adfærd
- Adfærd, vanedannende
- 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
- 2011039
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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