D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals
2018年6月6日 更新者:Aimee McRae-Clark、Medical University of South Carolina
In summary, this pilot study will explore the use of an innovative pharmacologic approach to the treatment of substance dependence through the facilitation of extinction of response to cocaine-conditioned cues in cocaine-dependent individuals.
If DCS proves successful in this preliminary study, a controlled treatment trial will be planned.
This novel approach could have implications for the treatment of multiple substance use disorders including methamphetamine, marijuana and opiate dependence.
研究概览
详细说明
Cocaine dependence remains a serious problem in the US today and in spite of two decades of intense research, efficacious pharmacotherapeutic treatments have not been identified.
Cocaine-associated environmental cues can elicit drug craving and exposure to cocaine-related cues is likely to be involved in relapse.
Emerging data supports the role of glutamate in extinction of associative learning in animal models of rear-conditioning and clinical studies of exposure treatment for anxiety disorders.
A recent study demonstrated DCS acceleration of cocaine-induced conditioned place preference in rats.
Exploration of DCS in facilitating extinction of response to drug-related cues in humans is needed.
The proposed study will extend these innovative and promising findings from the basic science arena and anxiety disorders field in a proof of concept investigation of DCS facilitation of extinction of response to cocaine-related cues in a human laboratory paradigm.
研究类型
介入性
注册 (实际的)
27
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
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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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
Inclusion Criteria:
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must meet DSM-IV criteria for current cocaine dependence. Subjects may meet criteria for abuse, but not dependence on any other substance within the past 60 days with the exception of nicotine. Because of the high comorbidity of cocaine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the testing session will be controlled. Alcohol has also been known to affect HPA function, however to enhance recruitment efforts individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification.
- Use of one of the following methods of birth control by female subjects: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
- Subjects must live within a 50-mile radius of our research program and have reliable transportation.
- Subjects must consent to remain abstinent from all drugs of abuse (except nicotine or alcohol) for 24 hours immediately prior to the GCRC admission.
- Subjects must consent to random assignment to the DCS vs. placebo conditions.
Exclusion Criteria:
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- 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 heart rate or skin conductance measurement.
- Individuals with creatinine clearance of 1.2 or greater as DCS is renally excreted.
- Subjects with a history of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder as these may impact cue reactivity.
- Subjects who are unwilling or unable to maintain abstinent from alcohol and other drugs of abuse (except nicotine) for 24 hours days prior to the cue procedure.
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or cocaine as appropriate) within the past 60 days.
- Subjects currently taking B-blockers, anti-arrythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
- Known or suspected hypersensitivity to DCS.
- Individuals taking medications that could adversely interact with study medications, including, but not limited to ethionamide, isoniazid, or amino acid supplements.
- Subjects with a history of epilepsy or seizure disorder.
- Subjects with significant liver impairment as DCS may increase serum transaminases.
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 |
|---|---|
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实验性的:DCS
D-Cycloserine 50 mg is a partial glutamate agonist.
Participants received DCS prior to cocaine cue exposure sessions.
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50 mg DCS
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安慰剂比较:Placebo
Saline comparator.
Participants received placebo prior to cocaine cue exposure sessions.
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安慰剂
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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 |
|---|---|---|
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Cocaine Craving Scale
大体时间:Immediately following cue exposure
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Scale assess cocaine craving following cocaine cue exposure after two administrations of DCS.
Subjects rate craving on a scale from 0-10 with 0 indicating "Not at all" and 10 indicating "Extremely".
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Immediately following cue exposure
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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:Aimee L McRae, Pharm.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
2006年9月1日
初级完成 (实际的)
2008年7月1日
研究完成 (实际的)
2008年7月1日
研究注册日期
首次提交
2008年10月23日
首先提交符合 QC 标准的
2008年10月24日
首次发布 (估计)
2008年10月27日
研究记录更新
最后更新发布 (实际的)
2018年7月6日
上次提交的符合 QC 标准的更新
2018年6月6日
最后验证
2018年6月1日
更多信息
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.