IV Nicotine Induced Changes in Hormone Function, Mood States and Behavior
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Effects of nicotine on hormones and mood states
研究概览
简要总结
Clinical studies are proposed to analyze the interactions between nicotine, alterations in endocrine hormones, mood and cardiovascular measures. The studies are designed to examine the contribution of gender and menstrual cycle phase. It is hypothesized that analysis of 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 understanding of the neurobiology of nicotine reinforcement.
详细描述
These clinical studies are designed to examine the acute effects of intravenous nicotine on anterior pituitary (ACTH, LH) 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 studies will examine the acute effects of intravenous nicotine on the gonadal steroid hormones and the reciprocal feedback regulation by LH. The temporal covariance of hormonal changes with serum nicotine levels and nicotine-induced changes in subjective states and cardiovascular measures will be measured. The covariance between nicotine-induced changes in endocrine, subjective and cardiovascular effects and the temporal concordance with increases in serum nicotine and cotinine levels will be determined. Gender and menstrual cycle phase influences on the effects of nicotine on HPA and HPG hormones and subjective effects will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between the ages of 18 and 40 who currently smoke at least 15 cigarettes every day, and who fulfill DSM-IV diagnostic criteria for nicotine dependence (305.10) will be eligible for participation.
- •No evidence of clinically significant disease based upon complete medical history and physical examination by Dr. Arthur Siegel (Chief of Internal Medicine, McLean Hospital).
- •Absence of DSM-IV Axis I Disorders other than nicotine dependence (305.10) as measured by the Structured Clinical Interview (SCID).
- •Routine laboratory blood tests including complete blood count, electrolytes, BUN and creatinine, liver function test, hepatitis panel and urinalysis will be performed. Laboratory parameters must be within the normal range. HBsAg must be negative but subjects who have hepatitis serology consistent with previous exposure to Hepatitis A, Hepatitis B, or Hepatitis C, but who do not have clinical and biochemical evidence of acute infection, will be acceptable.
- •Hematocrit levels ≥ 39% for males and ≥ 35% for females.
- •Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the study day.
- •Normal ECG.
- •Subjects must be able to read and understand instructions, as well as provide a valid informed consent.
排除标准
- •Women and men with any lifetime DSM-IV Axis I disorder other than nicotine abuse or dependence will be excluded.
- •Women who are pregnant will be excluded.
- •Women who use hormonal contraceptive medications will not be accepted for participation because this would confound the hormonal measures.
- •Men and women with clinically significant medical disorders will be excluded.
- •Obese and underweight subjects will be excluded. A mean Body Mass Index (ratio of weight (W) to height (H) squared; W/H2=kg/m2) will be calculated. Women with a mean Body Mass Index (BMI) of between 18.0-27.0 and men with a BMI between 21.4-29.0 will be accepted.
- •Treatment seeking subjects will not be selected but will be referred to local smoking cessation programs.
研究组 & 干预措施
Male Smokers
干预措施: Intravenous Nicotine (Drug)
Female Smokers (Mid-Luteal Phase; cycle days 18-22)
干预措施: Intravenous Nicotine (Drug)
Female Smokers (Early Follicular Phase; cycle days 4-8)
干预措施: Intravenous Nicotine (Drug)
结局指标
主要结局
Effects of nicotine on hormones and mood states
时间窗: From baseline to study completion (approximately 4 months for males and 8 months for females)
We are examining the effects of IV nicotine on serum nicotine levels, serum/plasma hormone levels and nicotine-induced changes in subjective statues, as measured by a visual analog scale.
次要结局
未报告次要终点
研究者
Scott Lukas
Director, Alcohol and Drug Abuse Research Center & Professor of Psychology (Neuroscience), Harvard Medical School
Mclean Hospital