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Clinical Trial Summary

The proposed clinical studies will analyze the interactions between nicotine, alterations in endocrine hormones, mood and cardiovascular measures. They also intend to examine the contribution of gender and menstrual cycle phase. These studies hypothesize that this novel focus on nicotine's rapid hormonal, cardiovascular and subjective effects will be important for developing novel biologic approaches to treatment for nicotine abuse and dependence as well as advancing our understanding of the neurobiology of nicotine reinforcement.


Clinical Trial Description

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 HPA and HPG hormones have not been clearly delineated. Accordingly, we 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


NCT number NCT01636310
Study type Interventional
Source Mclean Hospital
Contact
Status Suspended
Phase N/A
Start date December 2005
Completion date December 2016

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