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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
SINGLE
Enrollment
300
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.
Alcohol and Drug Abuse Research Center at McLean Hospital
Belmont, Massachusetts, United States
Effects of Nicotine on the hypothalamic-pituitary-adrenal (HPA) axis
The investigators are examining the effects of smoked nicotine on serum nicotine levels and serum/plasma hormone levels.
Time frame: From baseline to study completion (approximately 8 months for females)
Effects of Nicotine on the hypothalamic-pituitary-gonadal (HPG) axis
The investigators are examining the effects of smoked nicotine on serum nicotine levels and serum/plasma hormone levels.
Time frame: From baseline to study completion (approximately 8 months for females)
Effects of Nicotine on Mood States on the Visual Analog Scale
The investigators are examining the effects of smoked nicotine changes in subjective states("high," "like," "rush," "dizzy," etc.) as measured by a visual analog scale.
Time frame: From baseline to study completion (approximately 8 months for females)
Effects of Nicotine on cardiovascular measures
The investigators are examining the effects of smoked nicotine induced changes in cardiovascular measures, as measured by blood pressure and heart rate.
Time frame: From baseline to study completion (approximately 8 months for females)
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