NCT01636310

Multiple Cigarette Induced Changes in Hormone Function, Mood States and Behavior

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• 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 nicotine, alterations in endocrine hormones, mood and cardiovascular measures. They also intend to examine the contribution of gender and menstrual cycle phase. These studies hypothesize 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.

Detailed description

Clinical studies are proposed to measure the covariance between 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 HPA and HPG hormones have not been clearly delineated. Accordingly, we propose to compare the acute effects of nicotine in men 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	Two doses of nicotine will be utilized: 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.

Timeline

• Start date: 2005-12-01
• 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