Naltrexone Treatment

纳曲酮治疗

基本信息

批准号：
9066617
负责人：
GEORGIY BOBASHEV
金额：
$ 24.1万
依托单位：
RESEARCH TRIANGLE INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-06-01 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9066617
关键词：
Anhedonia Antidepressive Agents Anxiety Area Brief Psychiatric Rating Scale Buprenorphine Centers for Disease Control and Prevention (U.S.)Characteristics Clinical Clinical Research Clinical Trials Complex Controlled Clinical Trials Country Criminal Justice Data Data Set Demographic Aging Development Double-Blind Method Employment FDA approved Fluoxetine Formulation Funding Genetic Guanfacine HIV risk Health Heroin Heroin Dependence Heterogeneity Individual Influentials Injectable International Intervention Lead Link Measures Medical Genetics Mental Depression Methadone Methodology Methods Modality Modeling Naltrexone National Institute on Alcohol Abuse and Alcoholism Opiate Addiction Opioid Receptor Oral Outcome Patient-Focused Outcomes Patients Pharmacological Treatment Pilot Projects Placebo Control Population Characteristics Psychometrics Publishing ROC Curve Randomized Recording of previous events Research Personnel Respondent Risk Behaviors Russia Sampling Sex Education Training United States United States Substance Abuse and Mental Health Services Administration Work addiction alcohol abuse therapy base clinical practice clinically relevant cost craving demographics experience forest member model building model development novel outcome forecast personalized medicine predictive modeling predictive tools psychosocial receptor response treatment response

项目摘要

DESCRIPTION (provided by applicant): In this international pilot study we use data from four clinical trials of heroin dependence treatment to identify which patients will be better respondents to naltrexone treatment and among respondents which type of naltrexone formulation (oral, implantable, or injectable) leads to the best outcome. Although in the United States naltrexone has been FDA approved for treatment of opioid addiction it has been underutilized. In Russia (where substitution therapy is illegal), naltrexone is the only pharmacological treatment option. Naltrexone is available in three forms: oral and extended release, injectable, and implantable depot-formulations. A novel methodology (Model-based Random Forest, mobForest) (Garge et al. 2013) will be extended to heroin treatment and to the development of a single interpretable parsimonious model. These methods will be applied to combined data from past four naltrexone efficacy randomized double blind, double dummy, placebo- controlled clinical trials and identify which patients are likely to respond to different naltrexone formulations. These studies were conducted in St. Petersburg, Russia, have data on almost 1,000 patients with more than 400 individual-level variables spanning demographics, clinical, genetic, and psychometrics domains. We will develop validated predictive models that provide prognosis of patients' response. We will provide clinically- relevant interpretations to cross-cultural clinical practice, and assess potential use in a larger multi-country study.

描述（由申请人提供）：在这项国际试验研究中，我们使用来自海洛因依赖治疗的四个临床试验的数据来确定哪些患者对纳曲酮治疗的受访者以及在哪些类型的Naltrexone配方（口服，植入，可植入或可注射式）的受访者中导致了最佳结果。尽管在美国，Naltrexone已获得FDA批准用于治疗阿片类药物成瘾，但其未充分利用。在俄罗斯（替代治疗是非法的），纳曲酮是唯一的药理治疗选择。 Naltrexone有三种形式可用：口服和扩展释放，可注射和可植入的仓库形成。一种新颖的方法（基于模型的随机森林，Mobforest）（Garge等，2013）将扩展到海洛因处理，并开发出一种可解释的模型。这些方法将应用于过去四个纳曲酮疗效随机双盲，双假，安慰剂控制的临床试验的合并数据，并确定哪些患者可能对不同的纳曲酮配方反应。这些研究是在俄罗斯的圣彼得堡进行的，该数据涉及近1000名跨越人口统计学，临床，遗传和精神计量学领域的个人水平变量的患者。我们将开发有效的预测模型，以提供患者反应的预后。我们将为跨文化临床实践提供临床上相关的解释，并评估一项更大的多国研究中的潜在用途。