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Measuring Smoking Behaviors While Using Varenicline

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Andrew Strasser, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948155
First received: July 28, 2009
Last updated: December 15, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention Phase
Nicotine Dependence
Drug: Varenicline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Smoking Topography and Behaviors During Response to Varenicline

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Smoking Topography: Total Puff Volume [ Time Frame: Days 1-21 of each of 2 study periods ] [ Designated as safety issue: No ]
    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.

  • The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette. [ Time Frame: Days 1, 7, 21 of each of two 21 day study periods ] [ Designated as safety issue: No ]
    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.

  • Daily Cigarette Consumption [ Time Frame: Two 21 day study periods ] [ Designated as safety issue: No ]
    Average of the number of cigarettes smoked per day


Secondary Outcome Measures:
  • Total Nicotine Metabolites From Urine Samples [ Time Frame: Samples from Day 1 and Day 21 of two 21 day Periods ] [ Designated as safety issue: No ]
    Total urinary metabolites from urine samples collected at Day 1 and Day 21

  • Nicotine Levels From Urine Samples [ Time Frame: Samples from Day 1 and Day 21 of two 21 day Periods ] [ Designated as safety issue: No ]
    Nicotine levels from urine samples collected at Day 1 and Day 21.

  • Cotinine Levels From Urine Samples [ Time Frame: Samples from Day 1 and Day 21 of two 21 day Periods ] [ Designated as safety issue: No ]
    Cotinine levels from urine samples collected at Day 1 and Day 21.

  • Carbon Monoxide Levels [ Time Frame: Samples from Day 1 and Day 21 of two 21 day Periods ] [ Designated as safety issue: No ]
    Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure.

  • Subjective Measures to Assess Smoking Urges [ Time Frame: Days 21 of each of the two 21-day study periods, range 1(low)-7(high) ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Varenicline
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.
Other Name: Chantix
Experimental: 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'

Drug: Varenicline
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.
Other Name: Chantix

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948155

Locations
United States, Pennsylvania
Tobacco Use Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Pfizer
Investigators
Principal Investigator: Andrew Strasser, PhD University of Pennsylvania
  More Information

Publications:
Responsible Party: Andrew Strasser, Associate Professor Department of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948155     History of Changes
Other Study ID Numbers: 808930 
Study First Received: July 28, 2009
Results First Received: January 14, 2013
Last Updated: December 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
smoking
nicotine
varenicline

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016