Effects of Varenicline on Brain Activity During Nicotine Abstinence
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|ClinicalTrials.gov Identifier: NCT00602927|
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : May 2, 2011
Last Update Posted : May 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: Varenicline Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Neural Substrates of Varenicline's (Chantix®) Efficacy for Smoking Cessation|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
|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
- Percent Change BOLD Signal [ Time Frame: Day 13 ]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 ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602927
|United States, Pennsylvania|
|Tobacco Use Research Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Caryn Lerman, PhD||University of Pennsylvania|