A Phase 1 interventional study of Varenicline and Placebo in Tobacco Use Disorders, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 16 Years to 19 Years. Per ClinicalTrials.gov, last updated 2014-02-03.
Sponsored by Yale University · Phase 1, Interventional, and Basic science
This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the influence of varenicline on reward processing, cognitive control, and regulation of craving in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when compared with those receiving placebo, will have differential brain responses to anticipation of rewards, during exposure to the Stroop task, and in response to tobacco cues.
This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the influence of varenicline on reward processing, cognitive control, and regulation of craving in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when compared with those receiving placebo, will have increased activation of the ventral striatum (VS) in response to anticipation of rewards in the Monetary Incentive Delay Task (MIDT), decreased activation of the dorsolateral prefrontal cortex (dlPFC) during exposure to incongruent stimuli in the Stroop task, and reduced activation of the ventral striatum in response to tobacco cues, and increased activation of the dlPFC during regulation of responses to tobacco cues during the Regulation of Craving (ROC) task. The results of this pilot project will have important implications regarding the use of varenicline for treating tobacco dependence and understanding varenicline's neurobiological effects in adolescent smokers.
988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.
This study's enrollment of 16 is below the median of 90 across 863 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
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Drug: Varenicline
Drug: Placebo
1 mg bid varenicline titrated over a 2 week period
Also known as: Chantix
1 mg bid placebo titrated over a 2 week period
neural responses to the MIDT
The Monetary Incentive Delay Task (MIDT) will be administered during the fMRI at the end of 14 days of varenicline treatment
Time frame: During MRI following14 days of varenicline treatment
neural responses to the ROC
The Regulation of Craving (ROC)will be administered during the fMRI at the end of 14 days of varenicline treatment
Time frame: During MRI following14 days of varenicline treatment
neural responses to the Stroop
The Stroop will be administered during the fMRI at the end of 14 days of varenicline treatment
Time frame: During MRI following14 days of varenicline treatment
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Varenicline