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Measuring Smoking Behaviors While Using Varenicline

15. december 2014 opdateret af: Andrew Strasser, University of Pennsylvania

Assessment of Smoking Topography and Behaviors During Response to Varenicline

This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. The primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We will also examine puffing and nicotine cigarette choices during lab visits at baseline, and Days 7 and 21. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Tobacco Use Research Center

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

21 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • self report minimum 10 daily cigarettes
  • self report smoking every day past 5 years
  • between the ages 21-65
  • self report intention to try to quit smoking in the next 6 months

Exclusion Criteria:

  • self reported use of any nicotine-containing products other than non-menthol cigarettes
  • self reported history or current treatment of substance abuse (other than nicotine dependence)
  • self reported alcohol use greater than 25 standard drinks per week;
  • currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
  • self reported history or current diagnosis of any Axis 1 disorders except past depression
  • self reported serious or unstable disease within past year
  • self reported history of epilepsy or seizure disorder;
  • self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
  • self reported kidney function impairment
  • any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
  • less than 5 years of daily smoking
  • any medical condition or concomitant medication that could compromise participant safety or treatment
  • provide a baseline carbon monoxide (CO) reading < 10 ppm
  • self reported use of non filtered cigarettes
  • inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Varenicline before placebo

Drug (Varenicline (Chantix)): Placebo

Intervention to be administered is: participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
Andre navne:
  • Chantix
Eksperimentel: Placebo then Varenicline

Placebo: Drug Varenicline (Chantix)

Intervention to be administered is: participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Intervention 'Drug (Varenicline (Chantix)): Placebo'

Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
Andre navne:
  • Chantix

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Smoking Topography: Total Puff Volume
Tidsramme: Days 1-21 of each of 2 study periods
Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.
Days 1-21 of each of 2 study periods
The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
Tidsramme: Days 1, 7, 21 of each of two 21 day study periods
Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.
Days 1, 7, 21 of each of two 21 day study periods
Daily Cigarette Consumption
Tidsramme: Two 21 day study periods
Average of the number of cigarettes smoked per day
Two 21 day study periods

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Nicotine Metabolites From Urine Samples
Tidsramme: Samples from Day 1 and Day 21 of two 21 day Periods
Total urinary metabolites from urine samples collected at Day 1 and Day 21
Samples from Day 1 and Day 21 of two 21 day Periods
Nicotine Levels From Urine Samples
Tidsramme: Samples from Day 1 and Day 21 of two 21 day Periods
Nicotine levels from urine samples collected at Day 1 and Day 21.
Samples from Day 1 and Day 21 of two 21 day Periods
Cotinine Levels From Urine Samples
Tidsramme: Samples from Day 1 and Day 21 of two 21 day Periods
Cotinine levels from urine samples collected at Day 1 and Day 21.
Samples from Day 1 and Day 21 of two 21 day Periods
Carbon Monoxide Levels
Tidsramme: Samples from Day 1 and Day 21 of two 21 day Periods
Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure.
Samples from Day 1 and Day 21 of two 21 day Periods
Subjective Measures to Assess Smoking Urges
Tidsramme: Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach's α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period.
Days 21 of each of the two 21-day study periods, range 1(low)-7(high)

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

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.

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. januar 2009

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

28. juli 2009

Først indsendt, der opfyldte QC-kriterier

28. juli 2009

Først opslået (Skøn)

29. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. december 2014

Sidst verificeret

1. december 2014

Mere information

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

3
Abonner