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大的公共卫生问题，最广泛的单一干预是药理学治疗（例如，美沙酮维持）。药物治疗的重要好处是，它可以提供启动生活方式改变，稳定就业和在社会中的工作所必需的稳定性。因此，一个关键的问题是药物治疗与精神运动和认知表现障碍的程度可能影响功能。然而，很少有使用复杂评估技术进行的良好控制的研究已经解决了这个问题。 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使用最先进的评估技术和复杂的药理操作，灵活性，工作记忆，情节记忆和元素/元认知。具体目标1是比较美沙酮对性能的慢性影响和新批准的丁丙诺啡/纳洛酮组合产品，并将在实验1中使用依赖性阿片类药物滥用者进行实验剂量设计进行测试。具体目的2是评估高剂量美沙酮对性能的慢性作用，并将在实验1中使用实验剂量设计进行测试，并在实验2中使用患者组比较设计进行了比较，以比较三个先前在当地诊所中的现有美沙酮维持患者的性能，包括比先前在受控研究中进行的较高剂量进行的剂量。具体目的3-4是评估美沙酮对性能的急性影响以及与酒精结合使用美沙酮的作用（通常由阿片类药物滥用者滥用的药物），并将在实验3-4中的急性剂量设计中对依赖和非依赖性阿片类药物滥用者进行测试。具体目的5是评估美沙酮诱导的性能障碍的大小，相对于由对功能有充分文献作用的药物引起的，并将在实验4中使用酒精作为参考进行测试。临床医生可以使用从该项目获得的信息来指导重要决策，例如选择药物选择和给药时间表，以教育患者有关预期效果和相互作用以及潜在的活动限制，并根据药物治疗的阿片类药物虐待者的特定认知能力调整非药物治疗干预措施。该项目的数据还可以增强对药理和认知机制的科学理解。