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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
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.
Tobacco Use Research Center
Philadelphia, Pennsylvania, United States
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.
Time frame: Days 1-21 of each of 2 study periods
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.
Time frame: Days 1, 7, 21 of each of two 21 day study periods
Daily Cigarette Consumption
Average of the number of cigarettes smoked per day
Time frame: Two 21 day study periods
Total Nicotine Metabolites From Urine Samples
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
Nicotine Levels From Urine Samples
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
Cotinine Levels From Urine Samples
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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.
Time frame: Samples from Day 1 and Day 21 of two 21 day Periods
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.
Time frame: Days 21 of each of the two 21-day study periods, range 1(low)-7(high)