Repeated-dose behavioral intervention to reduce opioid overdose: a two-site randomized-controlled efficacy trial

重复剂量行为干预减少阿片类药物过量：一项两中心随机对照疗效试验

• 批准号: 9896799
• 负责人: PHILLIP O COFFIN
• 金额: $ 83.16万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-15 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9896799
• 关键词: Address; Adult; Affect; Alcohol or Other Drugs use; Behavior Therapy; Behavioral; Boston; Cessation of life; Client; Computer Assisted; Counseling; Country; Cox Proportional Hazards Models; Data; Dose; Drug usage; Education; Educational Curriculum; Effectiveness; Emergency Situation; Enrollment; Ensure; Epidemic; Event; Fentanyl; Funding; Future; Generations; Health; Heroin; Home environment; Individual; Intervention; Interview; Knowledge; Medical; Medical Records; Modeling; Motivation; Naloxone; National Institute of Drug Abuse; New England; Opiate Addiction; Opioid; Opioid Analgesics; Overdose; Participant; Patients; Persons; Pharmaceutical Preparations; Pilot Projects; Poisoning; Population; Population Intervention; Printed Media; Process; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Recurrence; Reporting; Resources; Risk; Risk Behaviors; Risk Factors; San Francisco; Site; Substance Use Disorder; Syringes; Testing; Time; Training; United States; Validation; Visit; attentional control; authority; base; behavior change; brief intervention; comparative efficacy; drug use behavior; efficacy trial; experience; follow-up; high risk; illicit opioid; mathematical model; mortality; motivational enhancement therapy; opioid epidemic; opioid mortality; opioid overdose; opioid use; opioid use disorder; opioid user; overdose prevention; overdose risk; prevent; programs; randomized trial; reduced substance use; screening; service programs; skills; social media; social stigma; synthetic opioid; treatment as usual; treatment services; trend; willingness

Project Summary/Abstract The United States is amidst an epidemic of opioid overdose, including opioid analgesics, heroin, and illicitly- manufactured fentanyl and related synthetic opioids. Multiple interventions to address opioid overdose have been employed, such as lay access to naloxone to reverse opioid overdose, yet the number of people dying each year from opioid overdose continues to increase each year. In addition to efforts to reduce mortality, efforts are needed to reduce the occurrence of any opioid overdose, particularly given the rapidity of synthetic opioid overdoses, which may restrict the time available to intervene once an overdose occurs. Opioid stewardship activities, necessary to avert yet another generation affected by the opioid epidemic, may paradoxically contribute to the illicit opioid epidemic, and expanded access to opioid use disorder treatment, while essential, is limited by resources, stigma, and the willingness of patients to accept the intervention. The NIDA-funded pilot study of REBOOT (repeated dose behavioral intervention to reduce opioid overdose), a motivational interviewing-based brief intervention addressing experienced and witnessed overdose events, resulted in substantial reductions in the occurrence of any opioid overdose, as well as the number of opioid overdoses that occurred during 16 months of follow-up. This full trial of REBOOT includes two regions of the United States – San Francisco, largely unaffected by the fentanyl epidemic – and Boston, at the epicenter of fentanyl use, overdose, and mortality. REBOOT will enroll 300 persons with opioid use disorder who are currently using opioids, have previously received take-home naloxone, and are at high-risk for recurrent overdose. Participants will be randomized to the intervention or attention-control and seen every four months for 16 months, with interval assessments for overdose events, overdose risk factors, engagement in substance use disorder treatment, and substance use. Medical records will be reviewed to capture unreported overdose events, including death. Results will determine if addressing overdose through motivational interviewing can reduce the occurrence of overdose, contributing to efforts to respond to this national emergency.

项目总结/摘要 美国正处于阿片类药物过量的流行之中，包括阿片类镇痛药，海洛因和其他药物。 制造芬太尼和相关的合成阿片类药物。解决阿片类药物过量的多种干预措施 被雇用，如奠定获得纳洛酮，以扭转阿片类药物过量，但死亡人数 每年因阿片类药物过量而死亡的人数每年都在增加。除了努力降低死亡率外， 需要努力减少任何阿片类药物过量的发生，特别是考虑到合成阿片类药物的快速性， 阿片类药物过量，这可能会限制一旦发生过量干预的时间。阿片 为避免又一代人受到阿片类药物流行病的影响而必须开展的管理活动， 自相矛盾地助长了非法阿片类药物的流行，并扩大了获得阿片类药物使用障碍治疗的机会， 虽然是必要的，但受到资源、耻辱和患者接受干预的意愿的限制。的 NIDA资助的REBOOT（减少阿片类药物过量的重复剂量行为干预）试点研究， 基于动机访谈的简短干预，解决经历和目睹的过量事件， 导致任何阿片类药物过量的发生率以及阿片类药物的数量大幅减少， 在16个月的随访期间发生的药物过量。REBOOT的完整试验包括两个区域， 美国-弗朗西斯科，基本上不受芬太尼流行的影响-和波士顿，在震中 芬太尼的使用过量和死亡率REBOOT将招募300名患有阿片类药物使用障碍的患者， 目前使用阿片类药物，以前接受过纳洛酮带回家，并且复发风险高 服药过量参与者将被随机分配到干预组或注意力控制组，每四个月观察一次 持续16个月，定期评估药物过量事件、药物过量风险因素、药物参与 使用障碍治疗和物质使用。将审查医疗记录，以记录未报告的药物过量 事件，包括死亡。结果将确定通过动机性访谈解决过量是否可以 减少用药过量的发生，为应对这一国家紧急情况的努力作出贡献。