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Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals

2018年5月2日 更新者:Megan Moran-Santa Maria、Medical University of South Carolina
Stress is associated with drug craving and relapse in substance-dependent individuals. Hormones released from the brain may mediate the behavioral response to stress. For example, several studies have indicated that oxytocin reduces stress in laboratory stress paradigms. Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet, little is known about the potential affects of oxytocin in cocaine-dependent individuals. Given these properties of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well as the anxiety associated with withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

33

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • South Carolina
      • Charleston、South Carolina、美国
        • Clinical Neurosciences Division-MUSC

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

1) General Inclusion / Exclusion Criteria Inclusion Criteria

  1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the CTRC admission. Nicotine dependence can affect HPA function therefore it would be ideal to exclude subjects with nicotine use. Because of the high comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. In addition, because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse and dependence will be included if they do not require medically supervised detoxification. Due to the high comorbidity of cocaine and marijuana dependence, individuals with marijuana dependence will be included.
  3. Subjects must consent to random assignment.
  4. Subjects must consent to outpatient admission to the CTRC.

Exclusion Criteria

  1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
  2. Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure.
  3. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
  4. Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.
  5. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
  6. Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response.
  7. Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with hormonal measurements within one month of test session.
  8. Subjects taking any psychotropic medications, opiates or opiate antagonists because these may affect test response. Subjects who have been maintained on SSRI's for 8 weeks will not be excluded.
  9. Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
  10. Subjects who are > 30% over ideal weight or have a BMI greater than 35 will be considered for study participation based on the clinical judgment of study staff.
  11. Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for three days prior to the stress task procedure.
  12. Subjects meeting DSM-IV criteria for substance dependence (other than alcohol, nicotine, marijuana orcocaine) within the past 60 days.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:安慰剂
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
实验性的:催产素
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
其他名称:
  • 催产素

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Salivary Cortisol Levels
大体时间:0 minutes post 15 minute stress task
salivary cortisol
0 minutes post 15 minute stress task

次要结果测量

结果测量
措施说明
大体时间
Likert Scale Rating of Subjective Stress
大体时间:0 minutes post 15 minute stress task
Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'
0 minutes post 15 minute stress task
Likert Scale Rating of Subjective Craving
大体时间:0 mintues post 15 minute stress task
Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'
0 mintues post 15 minute stress task

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Megan Moran-Santa Maria, Ph.D.、Medical University of South Carolina

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年7月1日

初级完成 (实际的)

2012年10月1日

研究完成 (实际的)

2012年10月1日

研究注册日期

首次提交

2011年7月13日

首先提交符合 QC 标准的

2013年10月11日

首次发布 (估计)

2013年10月16日

研究记录更新

最后更新发布 (实际的)

2018年6月4日

上次提交的符合 QC 标准的更新

2018年5月2日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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