Recovery Initiation and Management after Overdose (RIMO) Experiment

急救人员，包括医护人员、消防员和警察，经常接触到 在纳洛酮逆转过程中发挥关键作用的过量服药的个人 阿片类药物相关的过量用药。然而，将这些人与药物辅助的机制联系起来 缺乏过量用药后的治疗(MAT)。这项研究的目标是芝加哥的个人 在过去的一周内接受了急救人员的纳洛酮治疗，以逆转过量用药， 但没有进入垫子的人。研究参与者将通过与 芝加哥消防局(CFD)和警察局(CPD)；第一反应人员将接受培训，以寻求 在接受纳洛酮治疗后保持警觉和定向的个人的同意 研究人员作为纳洛酮标准方案的一部分。同意的人将被联系并 在服用纳洛酮后一周内对研究资格进行筛查；符合条件的参与者将 随机分配给对照组，即照常转诊至MAT，或恢复启动 和过量用药后管理(RIMO)，一种自信的联系和康复支持干预。 这种干预建立在循证干预的基础上，用于治疗联系、监测和 研究小组在之前的3次临床试验中对康复支持进行了评估。 第1阶段(R21)试点目标是：调整和试点测试断言干预(RIMO)以链接 过量用药已被纳洛酮逆转的阿片使用障碍(OUD)患者 由急救人员对MAT进行管理。将从#年的两个社区招募40人 芝加哥阿片类药物相关过量和纳洛酮用药率高，将随机 被指定接收“仅推荐”控制或“RIMO”。评估将在以下时间完成 从治疗记录中收集的基线和结果。招聘推荐方法和RIMO将 根据试点研究结果、RIMO参与者的焦点小组和研究意见进行细化 合作伙伴和咨询委员会，以及现有的干预程序手册将予以调整。 第二阶段(R33)实验将使用在 第一阶段招募400名个人，并随机将他们分配给仅限推荐的人员 控制或Rimo。所有参与者将在基线和1、3、6、9和 随机化后12个月。第二阶段研究的目标是评估RIMO的： 1.与MAT的联系、服药时间、辍学和MAT的总天数的直接影响 2.对复发时间、阿片类药物使用和阿片类药物过量的直接和间接影响(通过MAT) 3.(通过使用止痛药和阿片类药物)对阿片类药物相关死亡、乌德症状、 身体健康、精神健康和医疗保健利用成本。

Emergency responders, including paramedics, fire fighters, and police, routinely come into contact with individuals who have overdosed and play a critical role in administering naloxone to reverse opioid-related overdose. However, mechanisms to link these individuals to medication-assisted treatment (MAT) following an overdose are lacking. This study targets individuals in Chicago who have received naloxone administered by first responders within the past week to reverse an overdose, but who have not entered into MAT. Study participants will be recruited through partnerships with the Chicago Fire Department (CFD) and Police Department (CPD); first responders will be trained to seek consent from individuals who are alert and oriented after receiving naloxone for future contacts by research staff as part of the naloxone standard protocol. Those who consent will be contacted and screened for study eligibility within one week of naloxone administration; eligible participants will be randomly assigned either to the control group, i.e., referral to MAT as usual, or to Recovery Initiation and Management after Overdose (RIMO), an assertive linkage and recovery support intervention. This intervention builds on an evidenced-based intervention for treatment linkage, monitoring, and recovery support evaluated in 3 prior clinical trials by the study team. The Phase 1 (R21) Pilot Aim is to: Adapt and pilot test an assertive intervention (RIMO) to link individuals with opioid use disorders (OUD) whose overdose has been reversed by naloxone administered by first responders to MAT. Forty individuals will be recruited from two communities in Chicago with high rates of opioid-related overdose and naloxone administrations and will be randomly assigned to receive either the “referral only” control or “RIMO”. Assessments will be completed at baseline and outcomes collected from treatment records. Recruitment referral methods and RIMO will be refined based on pilot study findings, focus groups with RIMO participants, and input from study partners and advisory board, and the existing intervention procedures manual will be adapted. The Phase 2 (R33) Experiment will use the study recruitment and RIMO procedures refined in Phase 1 to recruit a total of 400 individuals and randomly assign them either to the referral only control or RIMO. All participants will receive standardized assessments at baseline and 1, 3, 6, 9, and 12 months post-randomization. Phase 2 Study Aims are to evaluate RIMO’s: 1. direct effect on linkage to MAT, length of time on medication, dropout, and total days of MAT 2. direct and indirect (via MAT) effects on time to relapse, opioid use, and opioid-related overdose 3. direct and indirect (via MAT and opioid use) effects on opioid-related fatalities, OUD symptoms, physical health, mental health and the cost of health care utilization.