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Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction

7. april 2017 opdateret af: Kristin Carson, The Queen Elizabeth Hospital

Evaluation of Nicotine Receptor Up-regulation Activity Through Metabolic Induction and Changes in Responsiveness Using Surrogate Evaluation Methods

Evaluation to determine if auto-induction can be used as a surrogate measure of nicotine receptor up-regulation through an observational study using nicotine replacement therapy for two weeks and no intervention for two weeks.

Studieoversigt

Status

Afsluttet

Betingelser

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

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • South Australia
      • Adelaide, South Australia, Australien, 5044
        • Kristin Carson

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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.
Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.
Andre navne:
  • Nikotinerstatningsterapi

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
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.
Baseline, Day 4, Day 14 and Day 28

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
Comparative evaluation patient instruments with ratios of metabolite induction
Baseline, Day 14 and Day 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2011

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

20. september 2011

Først indsendt, der opfyldte QC-kriterier

21. september 2011

Først opslået (Skøn)

22. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Available upon request

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 .

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