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This study will test the hypothesis that a medication called tolcapone (Brand Name: Tasmar) will help reduce cognitive problems that smokers experience when they quit. This study will also determine whether the benefits of this medication differ depending on a smokers' genetic background.
Tolcapone, an FDA-approved treatment for Parkinson's disease, improves cognitive performance in healthy controls with COMT val/val genotypes, putatively by increasing prefrontal dopamine levels. We propose a within-subject double-blind cross-over neuroimaging study of short-term (11 days) treatment with tolcapone (vs. placebo).
Forty-five chronic smokers (15 with val/val genotypes, 15 with met/met genotypes, and 15 with val/met genotypes) will undergo blood oxygenation level dependent (BOLD) fMRI during the two medication periods:
1. after 24 hours of monitored abstinence while on tolcapone, and
2. after 24 hours of monitored abstinence while on placebo (medication order counterbalanced with at least a 10-day washout).
The BOLD fMRI data will be acquired while subjects perform a working memory task (Fractal N-back), a sustained attention task (Continuous Performance Task; CPT), and a response inhibition task (Go/No-Go). The primary outcome is medication effects (within subject) on task-related BOLD activation after 24 hours of abstinence. Changes in behavioral performance and subjective symptoms will be examined in relation to brain activity changes.
The proposed study will provide a critical mechanistic understanding of the role of COMT in abstinence-induced cognitive symptoms that promote smoking relapse. Information obtained in this study may further establish cognitive performance measures as endophenotypes for nicotine dependence.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Tobacco Use Disorder
University of Pennsylvania
University of Pennsylvania
Published on BioPortfolio: 2014-07-23T21:12:18-0400
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Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.
The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.
Use of TOBACCO (Nicotiana tabacum L) and TOBACCO PRODUCTS.
Items used to aid in ending a TOBACCO habit.
Inhaling and exhaling the smoke of tobacco or something similar to tobacco.
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