Varenicline is the best smoking cessation agent to date; however it is only effective in a
subgroup of smokers and is associated with undesirable side effects in other subgroups. To
understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion
functional magnetic resonance imaging and a functional candidate gene association approach
using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic
varenicline administration in smokers. Brain and behavioral responses to smoking cues will be
will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat
smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats.
For the purposes of the clinical trial portion of the study, the change from cigarettes per
day at Baseline to the last day of treatment will be reported.
Phase:
Phase 2
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
National Institute on Drug Abuse (NIDA) National Institutes of Health (NIH)