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Smoked Nicotine Induced Changes in Hormone Function, Mood States and Behaviors

Nicotine Dependence Clinical Trial

Clinical Trial Summary

The proposed clinical studies will evaluate the acute effects of nicotine on the hypothalamic-pituitary-gonadal axis in women to test the hypothesis that nicotine alters gonadal steroid hormones, and/or disrupts feedback regulation of ovarian hormones by anterior pituitary hormones.

Clinical Trial Description

Clinical studies are proposed to measure the covariance between smoked 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 anterior pituitary (ACTH, FSH, LH) and adrenal (DHEA and cortisol) hormones have not been clearly delineated. Accordingly, these clinical studies will compare the acute effects of nicotine in men (studied previously) 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

Clinical Trial Details
NCT number NCT01636323
Study type Interventional
Source Mclean Hospital
Contact
Status Suspended
Phase N/A
Start date December 2008
Completion date December 2016
View Details
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