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临床试验/NCT02098434
NCT02098434已完成不适用

Implication of Ovarian Hormones in the Neural Correlates of Stress Induced Drug Craving

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2010年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Blood oxygen level dependent (BOLD)signal activation in limbic brain regions

研究概览

简要总结

The study is investigating the impact of progesterone and estrogen on brain areas that are involved with stress response and drug craving. The study will involve 40 women who will participate in the Montreal Imaging Stress Task (MIST) while undergoing fMRI scanning procedures. Half of the women will complete the procedures during the luteal phase of the menstrual cycle; the other half will complete procedures during the follicular phase. Subjective and physiological measures (cortisol levels) will be used to measure stress and craving response. Hypothesis 1A is that all women will exhibit increased craving, stress response, salivary cortisol and BNST and limbic nuclei activation in response to the MIST task. Hypothesis 1B is that these increased responses will be higher for women in the luteal phase than for women in the follicular phase of the menstrual cycle.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Montreal Imaging Stress Task

Experimental

Math task to induce stress response

干预措施: Montreal Imaging Stress Task (Behavioral)

结局指标

主要结局

Blood oxygen level dependent (BOLD)signal activation in limbic brain regions

时间窗: Scan visit, before and after MIST (day 1)

Exposure to the MIST task will increase activation in these brain areas as measured by fMRI scanning procedures, and the increase will be more pronounced for women in the luteal rather than follicular phase of the menstrual cycle.

次要结局

  • Stress response on 0-10 Likert scale(Scan visit, before and after MIST (day 1))
  • Subjective craving on 0-10 Likert scale(Scan visit, before and after MIST (day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Ovarian Hormones and Stress Induced Drug Craving | 临床试验