Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism
2018年6月12日 更新者:Medical University of South Carolina
Genetic and Brain Mechanisms of Naltrexone?s Treatment Efficacy for Alcoholism
The overarching aim of this trial is to evaluate naltrexone's efficacy in light of genetic variation and brain response to alcohol cues utilizing a neuroimaging paradigm.
This trial has four specific aims.
First, this trial will evaluate whether the presence of the OPRM1 Asp40 allele substitution is associated with improved treatment response to naltrexone in treatment-seeking alcoholics.
Second, it will evaluate whether there is a difference in the naltrexone dampening of the alcohol cue-induced brain activation dependent on OPRM1 genotype.
Third, it will explore whether alcohol cue-induced brain activation dampening by naltrexone might be a mediating factor in the treatment effects of naltrexone, the OPRM1 gene, or their interaction that might be observed in the first aim.
Finally, this trial will evaluate the effect of medication compliance, or adverse effects, on the observed medication by genotype treatment response.
A secondary aim will measure medication compliance and side effects based on OPRM1 genotype.
研究概览
研究类型
介入性
注册 (实际的)
358
阶段
- 第四阶段
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, Center for Drug and Alcohol Programs
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Charleston、South Carolina、美国、29425
- Medical University of South Carolin
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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 70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
- Age 18 70
- Subjects will meet criteria for primary alcohol dependence
- Consumes, on average, at least 5 standard drinks per day for men and 4 drinks per day for women in the 90 days pre-screening. Has at least 50% of days as heavy drinking days (as defined above).
- Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report and breathalyzer measurements
- Able to read and understand questionnaires and informed consent
- Lives within approximately 50 miles of the study site
Exclusion Criteria
- Currently meets DSM IV criteria for any other psychoactive substance dependence disorder except nicotine dependence
- Any psychoactive substance abuse, except marijuana, nicotine, and cocaine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen. May meet cocaine abuse criteria, but not dependence, and also must have two sequential urines free of illicit substances
- Meets DSM IV criteria for current and active axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder
- Meets DSM IV current criteria for dissociative disorder or eating disorders
- Has current suicidal ideation or homicidal ideation
- Need for maintenance or acute treatment with any psychoactive medication, except a stable dose (at least one month) of antidepressants
- Need for maintenance on anti-seizure medications (including topiramate and gabapentin)
- Use of disulfiram, acamprosate, or naltrexone in the last two weeks
- Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
- Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days abstinence
- Sexually active female of child-bearing potential who is pregnant (by urine HCG), nursing, or who is not willing to use a reliable form of birth control
- Has current charges pending for a violent crime (not including DUI-related offenses)
- Does not have a stable living situation
- African American heritage due to low prevalence of Asp40 (also see Inclusion of Women and Minorities section)
Exclusion Criteria of fMRI Procedure
- Having metal objects in the body that are deemed unsafe in the MRI environment.
- Severe claustrophobia that cannot be managed with support and encouragement.
- Morbid obesity such that placement in the MRI scanner is impossible.
- History of significant head injury leading to unconsciousness.
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:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:A118G A/A with Naltrexone
Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
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Naltrexone 25 or 50 mg per titration schedule
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安慰剂比较:A118G A/A with Placebo
Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks
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安慰剂
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有源比较器:A118G Any G with Naltrexone
Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
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Naltrexone 25 or 50 mg per titration schedule
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安慰剂比较:A118G Any G with Placebo
Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
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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 |
大体时间 |
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Percent Heavy Drinking Days by mu Opioid Receptor Gene
大体时间:Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16)
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Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16)
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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:Raymond F Anton, MD、Medical University of South Carolina
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2009年6月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2009年6月11日
首先提交符合 QC 标准的
2009年6月11日
首次发布 (估计)
2009年6月15日
研究记录更新
最后更新发布 (实际的)
2018年7月10日
上次提交的符合 QC 标准的更新
2018年6月12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.