Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-31 @ 1:41 AM
Study NCT ID:
NCT01589068
Status:
WITHDRAWN
Last Update Posted:
2024-01-17
First Post:
2012-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Progesterone on IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones and Subjective Ratings of Stimulant Drugs
Sponsor:
Mclean Hospital
Organization:
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Clinical studies never started; funds never received.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: