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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.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...