Reducing the Impact of Opioid Use Disorder on the Acquisition and Management of HIV and on Comorbidities

减少阿片类药物使用障碍对艾滋病毒感染和管理以及合并症的影响

• 批准号: 10017618
• 负责人: Henry Masur
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10017618
• 关键词: Acquired Immunodeficiency Syndrome; Affect; Behavior; Blood-Borne Pathogens; Clinic; Clinical; Collaborations; Comorbidity; Cytochrome P450; Dopamine; Enrollment; Goals; HIV; HIV/HCV; Individual; Metabolism; Midazolam; National Institute of Allergy and Infectious Disease; National Institute of Drug Abuse; National Institute of Mental Health; National Institute of Neurological Disorders and Stroke; Needle Sharing; Research Personnel; Stimulus; Substance Use Disorder; United States National Institutes of Health; Washington; craving; high risk behavior; opioid use disorder; phase 1 study; phase 2 study; transmission process; volunteer

The project is led by DCPFAP investigators with the active collaboration of NIMH, NIDA, NINDS, and NIAID. The goal of the DC Partnership for AIDS Progress has been to reduce the impact of HIV on Washington, D.C. It is apparent that substance use disorder is a major co-morbidity of HIV both in terms of increasing the likelihood of needle sharing which contributes to transmission of HIV and other blood borne pathogens, and increases the likelihood of high risk behavior that increase the likelihood that HIV and HCV will be transmitted due to behaviors by HIV and HCV infected and uninfected individuals. For the first study, a phase I study carried out at the NIH Clinical Center, investigators met with FDA to determine what studies needed to be done prior to a Phase II study. An interaction study between ANS 6697 and midazolam was indicated to determine whether cytochrome p450 metabolism was affected by ANS 6697. Twelve normal volunteers were enrolled, No interaction was detected. No effect on circulating dopamine metabolism was detected which was the anticipated result in individuals who had no substance use disorder and no stimulus for cravings. A phase II study is anticipated to start in fourth quarter 2019 or first quarter 2020 at the DC Clinics of DC PFAP.

该项目由DCPFAP调查人员领导，NIMH、NIDA、NINDS和NIAID积极合作。 华盛顿特区艾滋病进展伙伴关系的目标一直是减少艾滋病毒对华盛顿特区的影响。显然，物质使用障碍是艾滋病毒的主要共同发病，这既增加了共用针头导致艾滋病毒和其他血液传播病原体传播的可能性，也增加了高风险行为的可能性，增加了艾滋病毒和丙型肝炎病毒感染者和未感染者的行为传播艾滋病毒和丙型肝炎病毒的可能性。 第一项研究是在NIH临床中心进行的I期研究，研究人员与FDA会面，以确定在II期研究之前需要进行哪些研究。一项ANS6697和咪达唑仑的相互作用研究表明，ANS6697是否影响细胞色素P450的代谢。12名正常志愿者参加，未发现交互作用。没有检测到对循环多巴胺代谢的影响，这是在没有药物使用障碍和没有渴望刺激的个人中预期的结果。 第二阶段研究预计将于2019年第四季度或2020年第一季度在DC PFAP的DC诊所开始。