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Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

21. november 2013 opdateret af: H. Lee Moffitt Cancer Center and Research Institute
The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We proposed the following primary hypotheses:

  1. Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving varenicline versus placebo.
  2. Cue-provoked cravings (self-report and physiological responding) would be lower in participants receiving varenicline versus placebo. (Secondary indices of craving include heart rate and skin conductance.)
  3. The two primary indices of nicotine reward/reinforcement (mCEQ and choice index) would be lower in participants receiving varenicline versus placebo. (Secondary indices of nicotine reinforcement include smoking topography variables.)

A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St. Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to, local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public transportation).

Following the screening session, participants were randomly assigned to receive either varenicline or placebo medication.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

163

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Tampa, Florida, Forenede Stater, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

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 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 18-60 years of age
  • Smoke at least 15 cigarettes daily
  • Expired-air carbon monoxide (CO) > 10 ppm
  • Medically eligible to receive Varenicline.

Exclusion Criteria:

  • Patients who are pregnant or lactating
  • Who show evidence of renal dysfunction (BUN > 25 mg/dL, or creatinine > 1.3 mg/dL)
  • Are using other smoking cessation medications
  • Have current psychiatric disorders (i.e. major depression, manic depression, and/or psychotic episodes) as determined by the Structured Clinical Interview for DSM Disorders (SCID) (First et al., 1996), will be excluded

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Varenicline
For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
Medicin: varenicline
Participants in this group received varenicline according to the schedule in the Arm Description.
Andre navne:
  • Chantix™
Placebo komparator: Placebo
Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
Medicin: placebo
Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tonic Craving Score (QSU) Based on Self Reports
Tidsramme: 3 weeks per participant
Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.
3 weeks per participant
Cue-provoked Cravings
Tidsramme: 3 weeks per participant
Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?"
3 weeks per participant

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Smoking Topography - Number of Puffs on a Cigarette
Tidsramme: 3 weeks per participant
# Puffs = total number of puffs taken at Assessment Session.
3 weeks per participant
A Measure of the Subjective Expected Value of a Cigarette
Tidsramme: 3 weeks per participant
The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).
3 weeks per participant

Samarbejdspartnere og efterforskere

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Samarbejdspartnere

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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

1. september 2008

Primær færdiggørelse (Faktiske)

1. august 2010

Studieafslutning (Faktiske)

1. august 2010

Datoer for studieregistrering

Først indsendt

4. september 2008

Først indsendt, der opfyldte QC-kriterier

4. september 2008

Først opslået (Skøn)

5. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. november 2013

Sidst verificeret

1. oktober 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MCC-15444
  • 106842 (Anden identifikator: USF IRB)

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 .

Kliniske forsøg med varenicline

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner