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Measuring Smoking Behaviors While Using Varenicline

15 décembre 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

48

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Tobacco Use Research Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autres noms:
  • Chantix
Expérimental: 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.
Autres noms:
  • Chantix

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Smoking Topography: Total Puff Volume
Délai: 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.
Délai: 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
Délai: Two 21 day study periods
Average of the number of cigarettes smoked per day
Two 21 day study periods

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Total Nicotine Metabolites From Urine Samples
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2009

Achèvement primaire (Réel)

1 novembre 2010

Achèvement de l'étude (Réel)

1 novembre 2010

Dates d'inscription aux études

Première soumission

28 juillet 2009

Première soumission répondant aux critères de contrôle qualité

28 juillet 2009

Première publication (Estimation)

29 juillet 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

16 décembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 décembre 2014

Dernière vérification

1 décembre 2014

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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