This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary goal of this Phase I study is to demonstrate the safety of the combination of modafinil and nicotine replacement in nicotine dependent adolescent smokers. It is hypothesized that combined modafinil and nicotine replacement will assist in management of symtoms of inattention and depressed mood along with other nicotine withdrawal symptoms in tobacco-deprived nicotine dependent adolescent smokers. The safety of modafinil and nicotine, alone and in combination will be assessed using physiological, subjective and behavioral outcome measures in nicotine-dependent adolescent smokers. In addition, behavioral and subjective measures of inattention and depressed mood along with other measures of nicotine withdrawal will also be measured to conduct an initial test of the potential efficacy of these drugs, alone and in combination, on these symptoms which are associated with relapse during smoking cessation. Information from this study will inform future clinical studies by examining safety and behavioral effects of these drugs, alone and in combination.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR002602-22
Application #
7379027
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
22
Fiscal Year
2006
Total Cost
$16,719
Indirect Cost
Name
University of Kentucky
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
939017877
City
Lexington
State
KY
Country
United States
Zip Code
40506
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