NCT01589081

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Intravenous Nicotine	Subjects will be given an IV challenge dose of nicotine or placebo in a constant volume of 2 mL on any study session day. The nicotine solutions (1.0 mg/70kg or 1.5 mg/70kg or 2.0 mg/70kg) will be administered over 1 min. This rate of drug delivery (2 mL over one minute) has been safe in our IRB-approved studies of nicotine. Most investigators have administered nicotine over 10 seconds without any adverse reactions. We concur with the IRB recommendation that the lower doses (1.0 mg/70kg; and 1.5 mg/70kg) will be administered first and the higher dose (2.0 mg/70kg) will be administered last.
DRUG	Progesterone	To stimulate the luteal phase of the menstrual cycle, Prometrium capsules containing 200 mg of micronized progesterone or placebo (lactose containing) capsules will be administered orally at 120 minutes before the injection of IV nicotine.

Timeline

• Start date: 2008-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-05-01
• Last updated: 2024-01-17

Locations

1 site across 1 country: United States