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Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT (XRNT)

2014年10月10日 更新者:Wim van den Brink、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Feasibility, Mechanism of Action and Potential Side Effects of Extended Release Depot Naltrexone in Opioid Dependent Patients

The aim of this project is to study brain functions of 20 heroin addicts (compared to brain functions of 20 healthy controls) just before and during a three month extended release naltrexone treatment using functional MRI and dopamine transporter SPECT.

The following hypotheses are tested:

  • XRNT modulates the fMRI response to drug cues in predetermined brain regions.
  • The expression of striatal transporters (assessed with SPECT) will decrease after a three-month course of extended release naltrexone

研究概览

详细说明

Heroin dependence is a quintessential international health problem, with a significant prevalence. Drug free treatments, including pharmacologically supported interventions using oral naltrexone, have not been very successful, mainly due to low compliance. The recent introduction of Vivitrol®, consisting of monthly injections, may create new opportunities. Vivitrol® is an innovative treatment delivery method that blocks the rewarding effects of heroin.

研究类型

介入性

注册 (预期的)

40

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

      • Amsterdam、荷兰、P.O. Box 22660
        • Academic Medical Center

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 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Heroin dependent patients: have a diagnosis of opioid dependence according to DSM-IV criteria, heroin as primary drug of abuse and inhalation as primary route of administration.
  • Healthy controls: no diagnosis of substance dependence, no current psychotropic medication. Care will be taken to match controls for gender, age, smoking status, IQ and handedness.

Exclusion Criteria:

  • Age below 18 or over 55
  • Medical contraindications for XRNT or MRI (Langleben 2006; Langleben, Ruparel et al. 2008). Briefly, the former include candidates with known hypersensitivity to naltrexone,PLG (poly-lactide-coglycolide), carboxymethylcellulose, or any other components of the Vivitrol® diluent, hepatic or renal disease, chronic pain syndromes, female subjects who are pregnant or lactating, or are of child bearing potential and are not using an acceptable method of birth control. MRI contraindications include chronic medical (neurological, cardiovascular, infectious, metabolic, etc) conditions that may affect the brain morphology and/or activity and indwelling foreign metallic or magnetically sensitive objects and devices, such as shrapnel, pacemakers, orthopaedic fixation devices or vascular stents
  • Presence of disorders precluding normal perception of visual and auditory stimuli, such as color blindness, deafness, severe myopia, etc.
  • Patients with a history of or current psychosis or current major depressive disorder with suicidal ideation
  • Patients who are being treated under forced treatment conditions
  • History or evidence of disorders that may affect cerebral function or circulation, such as diabetes and other metabolic disorders, encephalopathy, cardiovascular or cerebrovascular disease, history of head trauma with depressed skull fracture or prolonged loss of consciousness and history of brain surgery
  • Female subjects: women who are pregnant or breast-feeding
  • Current psychotropic medication
  • Use of any prescription medications that could affect alertness or the circulatory system
  • IQ < 70
  • Naltrexone use within the past 6 months
  • Baseline aspartate aminotransferase or alanine aminotransferase more than three times the upper limit of normal
  • Patients with no intention to be opioid-free for a minimum of 7 days before starting XRNT treatment

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:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Depot Naltrexone
naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
其他名称:
  • 维维特罗

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
Brain functions
大体时间:3 months
Brain functions of 20 heroin addicts just before and during a three month extended release naltrexone treatment using both functional MRI and dopamine transporter SPECT, compared to brain functions of 20 healthy controls.
3 months

次要结果测量

结果测量
措施说明
大体时间
Feasibility and potential efficacy
大体时间:3 months
The feasibility and potential efficacy of extended release naltrexone in a pilot sample of 20 Dutch heroin addicts in terms of (a) the percentage of patients that actually starts treatment when invited and (b) the percentage of 3 months retention.
3 months

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:Wim van den Brink, MD PhD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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。

一般刊物

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

2013年1月1日

初级完成 (实际的)

2014年10月1日

研究完成 (实际的)

2014年10月1日

研究注册日期

首次提交

2011年11月10日

首先提交符合 QC 标准的

2011年11月10日

首次发布 (估计)

2011年11月15日

研究记录更新

最后更新发布 (估计)

2014年10月13日

上次提交的符合 QC 标准的更新

2014年10月10日

最后验证

2014年10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.

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