The clinical studies propose to study the abuse-related effects of nicotine after progesterone administration during the follicular phase in women of reproductive age. Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the role of the HPA axis in the abuse-related effects of nicotine.
These clinical studies will analyze the interactions between progesterone, nicotine, alterations in endocrine hormones, mood and cardiovascular measures. The studies also intend to examine the contribution of menstrual cycle phase. It is hypothesized that this novel focus on nicotine's rapid hormonal, cardiovascular and subjective effects will be important for developing novel biologic approaches to treatment for nicotine abuse and dependence as well as advancing our understanding of the neurobiology of nicotine reinforcement.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
SINGLE
Enrollment
45
Two doses of nicotine will be utilized in the study: 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). 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.
Prometrium capsules containing 200 mg of micronized progesterone will be obtained from Solvay Pharmaceuticals, Inc. (210 Main Street West, Baudette, MN, 56623, phone (218) 634-3500, fax (218) 634-3540).
Alcohol and Drug Abuse Research Center at McLean Hospital
Belmont, Massachusetts, United States
Effects of Progesterone on Nicotine-Induced Changes on the hypothalamic-pituitary adrenal (HPA) axis
The investigators are examining the effects of progesterone on smoked nicotine induced changes in 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 a Visual Analog Scale of Mood States
The investigators are examining the effects of progesterone on smoked nicotine induced 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 progesterone on 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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