University of Pennsylvania Addiction Treatment Research Center
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT01524627
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Other names: Chantix
Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective for Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Other names: Sugar Pill
Time frame: last week of treatment (1-8 weeks)
Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled
University of Pennsylvania
Other
Characterizing a Cue-vulnerable Pharmaco-responsive Endophenotype in Smokers
Acronym: VSMK
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