NCT01636323

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
OTHER	Nicotine	Subjects will be given two doses of nicotine: a commercially available, high-yield nicotine cigarette (Marlboro Red; Phillip Morris brand) and a denicotinized cigarette (Murty Pharmaceuticals Inc., Lexington, KY). The high dose cigarettes contain 15.48 mg of nicotine and 16 mg of tar based on analysis by the Massachusetts Department of Public Health (MDPH, 1998). According to the Massachusetts Department of Public Health classification, cigarettes with a nicotine yield of 1.2 mg or higher are high nicotine cigarettes. The low nicotine cigarettes contain 1.1 mg of nicotine and deliver 0.1 mg of nicotine and 2.8 mg of tar based on analyses provided by the manufacturer.

Timeline

• Start date: 2008-12-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-07-10
• Last updated: 2013-01-15

Locations

1 site across 1 country: United States