Effects of Varenicline on Brain Activity During Nicotine Abstinence
This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Neural Substrates of Varenicline's (Chantix®) Efficacy for Smoking Cessation|
- Percent Change BOLD Signal [ Time Frame: Day 13 ] [ Designated as safety issue: No ]We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.
- Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time) [ Time Frame: Day 13 ] [ Designated as safety issue: No ]We examined the difference in correct reaction time on the N-back task between varenicline and placebo treatment. Models included terms for the main effect of treatment period (varenicline vs. placebo), memory load (0-back, 1-back, 2-back, 3-back) and covariates. We tested for interactions between nicotine dependence severity and treatment.
|Study Start Date:||November 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.
|Active Comparator: Varenicline||
Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily
Other Name: Chantix
Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602927
|United States, Pennsylvania|
|Tobacco Use Research Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Caryn Lerman, PhD||University of Pennsylvania|