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Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect

Nicotine Dependence Clinical Trial

Official title:
Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect

Clinical Trial Summary

The proposed clinical studies will analyze the interactions between progesterone, nicotine, alterations in endocrine hormones, mood and cardiovascular measures. It is hypothesized that the administration of progesterone at a dose that mimics luteal phase levels in normal cycling women will diminish the positive subjective effects of nicotine, as has been consistently observed for cocaine. This novel approach could have direct implications for facilitating smoking cessation treatment in women of reproductive age

Clinical Trial Description

These clinical studies are designed to examine the effects of progesterone on IV nicotine induced changes on anterior pituitary (ACTH, LH, and Prolactin) and adrenal hormones (DHEA and cortisol). We also plan to study norepinephrine (NE) and epinephrine (E), because nicotine stimulates rapid release of NE and E in preclinical and clinical studies. The study will examine the acute effects of progesterone on the effects of IV nicotine on the HPG axis. Progesterone's influence on the acute effects of nicotine on the gonadal steroid hormones (estradiol, testosterone, progesterone) are unknown. The effects of progesterone on nicotine induced changes on gonadal steroid hormones and the reciprocal feedback regulation by LH will also be examined. The temporal covariance of progesterone influenced hormonal changes with serum nicotine levels and nicotine-induced changes in subjective states and cardiovascular measures will be analyzed. Finally, the covariance between the effects of progesterone on nicotine-induced changes in endocrine, subjective and cardiovascular effects and the temporal concordance with increases in serum nicotine and cotinine levels will be determined. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01589081
Study type Interventional
Source Mclean Hospital
Contact
Status Withdrawn
Phase N/A
Start date September 2008
Completion date December 1, 2015
View Details
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