Back to resultsMeasuring Smoking Behaviors While Using Varenicline
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring smoking, nicotine, varenicline
Eligibility 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
Sites / Locations
- Tobacco Use Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Varenicline before placebo
Placebo then Varenicline
Arm Description
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.
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'
Outcomes
Primary Outcome Measures
Smoking Topography: Total Puff Volume
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.
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
Average of the number of cigarettes smoked per day
Secondary Outcome Measures
Total Nicotine Metabolites From Urine Samples
Total urinary metabolites from urine samples collected at Day 1 and Day 21
Nicotine Levels From Urine Samples
Nicotine levels from urine samples collected at Day 1 and Day 21.
Cotinine Levels From Urine Samples
Cotinine levels from urine samples collected at Day 1 and Day 21.
Carbon Monoxide Levels
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
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.
Full Information
NCT ID
NCT00948155
First Posted
July 28, 2009
Last Updated
December 15, 2014
Sponsor
University of Pennsylvania
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00948155
Brief Title
Measuring Smoking Behaviors While Using Varenicline
Official Title
Assessment of Smoking Topography and Behaviors During Response to Varenicline
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
smoking, nicotine, varenicline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varenicline before placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo then Varenicline
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Smoking Topography: Total Puff Volume
Description
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.
Time Frame
Days 1-21 of each of 2 study periods
Title
The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
Description
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.
Time Frame
Days 1, 7, 21 of each of two 21 day study periods
Title
Daily Cigarette Consumption
Description
Average of the number of cigarettes smoked per day
Time Frame
Two 21 day study periods
Secondary Outcome Measure Information:
Title
Total Nicotine Metabolites From Urine Samples
Description
Total urinary metabolites from urine samples collected at Day 1 and Day 21
Time Frame
Samples from Day 1 and Day 21 of two 21 day Periods
Title
Nicotine Levels From Urine Samples
Description
Nicotine levels from urine samples collected at Day 1 and Day 21.
Time Frame
Samples from Day 1 and Day 21 of two 21 day Periods
Title
Cotinine Levels From Urine Samples
Description
Cotinine levels from urine samples collected at Day 1 and Day 21.
Time Frame
Samples from Day 1 and Day 21 of two 21 day Periods
Title
Carbon Monoxide Levels
Description
Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure.
Time Frame
Samples from Day 1 and Day 21 of two 21 day Periods
Title
Subjective Measures to Assess Smoking Urges
Description
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.
Time Frame
Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Strasser, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tobacco Use Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22695488
Citation
Ashare RL, Tang KZ, Mesaros AC, Blair IA, Leone F, Strasser AA. Effects of 21 days of varenicline versus placebo on smoking behaviors and urges among non-treatment seeking smokers. J Psychopharmacol. 2012 Oct;26(10):1383-90. doi: 10.1177/0269881112449397. Epub 2012 Jun 13.
Results Reference
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Measuring Smoking Behaviors While Using Varenicline
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