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Clinical Trial Summary

The proposed clinical studies will analyze the interactions between progesterone, nicotine, fMRI measures of patterns of brain activity, covariance with 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 will examine the effects of progesterone on the acute effects of IV nicotine and on patterns of brain activation in areas of the brain with high levels of nicotine receptors. This will be correlated with serum nicotine levels, nicotine-induced changes in subjective states, and endocrine measures of the HPA and HPG axes. The temporal covariance of progesterone's effects on serum nicotine levels and nicotine-induced changes in subjective states and cardiovascular measures will be analyzed. The covariance between the effects of progesterone on nicotine-induced changes in BOLD fMRI, 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


NCT number NCT01589068
Study type Interventional
Source Mclean Hospital
Contact
Status Withdrawn
Phase N/A
Start date January 2007
Completion date December 1, 2015

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