Nicotine Dependence Clinical Trial
Official title:
Effects of IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones, and Subjective Ratings of Stimulant Drug Effect
Clinical studies are proposed to measure the covariance between nicotine-induced changes in endocrine, subjective and cardiovascular effects and the temporal concordance with increases in serum nicotine and cotinine levels. Possible gender and menstrual cycle phase influences on the effects of nicotine on hypothalamic-pituitary-adrenal axis (HPA) and hypothalamic-pituitary-gonadal axis (HPG) hormones have not been clearly delineated. Accordingly, the investigators propose to compare the acute effects of nicotine in men and women, and to study women at the follicular and the luteal phases of the menstrual cycle.
This clinical study will analyze the interactions between nicotine, endocrine hormone alterations, mood, cardiovascular measures, and patterns of brain activation to determine if they are affected by gender and menstrual cycle phase. These studies will advance our understanding of the neurobiology of nicotine's behavioral effects, and could be important in developing novel treatments for smoking cessation. Cigarette smoking remains a leading cause of death and disease and the proposed studies will advance knowledge of the ways in which gender and menstrual cycle phase may influence patterns of brain activation induced by nicotine and consequently the development and maintenance of nicotine dependence. ;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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