Clinical trial NCT00948155: Measuring Smoking Behaviors While Using Varenicline
Official title: Assessment of Smoking Topography and Behaviors During Response to Varenicline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nicotine Dependence
Keywords: smoking
nicotine
varenicline
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-07-29
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Smoking Topography: Total Puff Volume
timeFrame: Days 1-21 of each of 2 study periods
measure: The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
timeFrame: Days 1, 7, 21 of each of two 21 day study periods
measure: Daily Cigarette Consumption
timeFrame: Two 21 day study periods
Secondary outcomes:
measure: Total Nicotine Metabolites From Urine Samples
timeFrame: Samples from Day 1 and Day 21 of two 21 day Periods
measure: Nicotine Levels From Urine Samples
timeFrame: Samples from Day 1 and Day 21 of two 21 day Periods
measure: Cotinine Levels From Urine Samples
timeFrame: Samples from Day 1 and Day 21 of two 21 day Periods
measure: Carbon Monoxide Levels
timeFrame: Samples from Day 1 and Day 21 of two 21 day Periods
measure: Subjective Measures to Assess Smoking Urges
timeFrame: Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Tobacco Use Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrew Strasser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.