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Effects of Opioid Pharmacotherapy on Functioning

阿片类药物治疗对功能的影响

基本信息

批准号：
7458957
负责人：
MIRIAM Z. MINTZER
金额：
$ 34.63万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-01 至 2010-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7458957
关键词：
Acute Address Affect Agonist Alcohol abuse Alcohol consumption Alcohols Arts Attention Buprenorphine Chronic Clinic Cognitive Control Groups Controlled Study Crossover Design Daily Data Development Dose Double-Blind Method Drug Controls Employment Episodic memory Heroin Users Impairment Individual Intervention Life Style Maintenance Methadone Naloxone Numbers Opiate Addiction Opioid Patients Perception Performance Pharmaceutical Preparations Pharmacological Treatment Pharmacology Pharmacotherapy Placebos Pliability Policies Public Health Range Reaction Time Relative (related person)Research Research Personnel Schedule Sensory Series Short-Term Memory Societies Substance abuse problem Techniques Testing United States United States Food and Drug Administration Week base comparison group day design oculomotor opioid abuse programs psychosocial research study trend visual tracking

项目摘要

DESCRIPTION (provided by applicant): Opioid dependence is a significant public health problem and the most widespread single intervention is pharmacological treatment (e.g., methadone maintenance). An important benefit of pharmacotherapy is that it can provide the stability necessary to initiate lifestyle changes, obtain steady employment and function in society. Thus, a critical question is the extent to which pharmacotherapy is associated with impairment in psychomotor and cognitive performance that might affect functioning. Yet, few well-controlled studies using sophisticated assessment techniques have addressed this question. In this research application with translational implications, four experiments are proposed to evaluate the effects of pharmacotherapy for opioid dependence on a wide range of functions relevant to performance of daily activities and to participating in and benefiting from cognitive/psychosocial aspects of substance abuse treatment, including oculomotor function, sensory perception, psychomotor coordination, reaction time, visual tracking, attention (focused, selective, and divided), conceptual flexibility, working memory, episodic memory, and metamemory/metacognition, using state-of-the-art assessment techniques and sophisticated pharmacological manipulations. Specific Aim 1 is to compare the chronic effects on performance of methadone and the newly-approved buprenorphine/naloxone combination product, and will be tested in Experiment 1 using an experimental dosing design in dependent opioid abusers. Specific Aim 2 is to evaluate the chronic effects of high-dose methadone on performance, and will be tested in Experiment 1 using an experimental dosing design and in Experiment 2 using a patient group comparison design to compare the performance of three pre-existing groups of methadone maintenance patients in local clinics, including a group maintained on higher doses than those previously evaluated in controlled studies. Specific Aims 3-4 are to evaluate the acute effects of methadone on performance and the effects on performance of methadone in combination with alcohol (a drug commonly abused by opioid abusers), and will be tested in an acute dosing design in Experiments 3-4 in dependent and non-dependent opioid abusers. Specific Aim 5 is to evaluate the magnitude of methadone-induced performance impairment relative to that induced by a drug with well-documented effects on functioning, and will be tested in Experiment 4 using alcohol as a reference. Information obtained from this project can be used by clinicians to guide important decisions such as medication selection and dosing schedules, to educate patients about expected effects and interactions, as well as potential activity restrictions, and to tailor non-pharmacological treatment interventions to the specific cognitive capabilities of opioid abusers being treated with pharmacotherapy. Data from this project may also enhance the scientific understanding of pharmacological and cognitive mechanisms.

描述（由申请人提供）：阿片类药物依赖是一个重要的公共卫生问题，最广泛的单一干预措施是药物治疗（例如，美沙酮维持）。药物治疗的一个重要好处是，它可以提供必要的稳定性，以开始改变生活方式，获得稳定的就业和社会功能。因此，一个关键的问题是药物治疗在多大程度上与可能影响功能的精神和认知表现障碍有关。然而，很少有使用复杂评估技术的对照研究解决了这个问题。在这项具有翻译意义的研究应用中，提出了四个实验来评估阿片类药物依赖药物治疗对与日常活动表现相关的广泛功能以及参与和受益于物质滥用治疗的认知/心理社会方面的影响，包括眼功能，感觉知觉，心理协调，反应时间，视觉跟踪，注意力（集中的，选择性的，和分开的），概念灵活性，工作记忆，情节记忆，和元记忆/元认知，使用国家的最先进的评估技术和复杂的药理学操作。具体目的1是比较美沙酮和新批准的丁丙诺啡/纳洛酮复方制剂对性能的长期影响，并将在实验1中使用实验给药设计在阿片类药物依赖者中进行测试。具体目标2是评价高剂量美沙酮对性能的慢性影响，并将在实验1中使用实验剂量设计进行测试，在实验2中使用患者组比较设计，以比较当地诊所中三个预先存在的美沙酮维持患者组的性能，包括维持在比先前在对照研究中评价的剂量更高的剂量的组。具体目的3-4是评价美沙酮对表现的急性影响以及美沙酮与酒精（阿片类药物滥用者通常滥用的药物）联合使用对表现的影响，并将在实验3-4的急性给药设计中在依赖性和非依赖性阿片类药物滥用者中进行测试。具体目标5是评价美沙酮诱导的表现损害相对于对功能有充分记录的影响的药物诱导的表现损害的程度，并将在实验4中使用酒精作为参照进行测试。从该项目中获得的信息可用于指导临床医生做出重要决定，如药物选择和给药方案，教育患者有关预期效果和相互作用以及潜在的活动限制，并根据接受药物治疗的阿片类药物滥用者的特定认知能力定制非药物治疗干预措施。来自该项目的数据也可能增强对药理学和认知机制的科学理解。