PDF(Pubmed)
Abstract：
UNASSIGNED: Injectable extended-release (XR)-naltrexone is an effective treatment option for opioid use disorder (OUD), but the need to withdraw patients from opioid treatment prior to initiation is a barrier to implementation.
UNASSIGNED: To compare the effectiveness of the standard procedure (SP) with the rapid procedure (RP) for XR-naltrexone initiation.
UNASSIGNED: The Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone study was an optimized stepped-wedge cluster randomized trial conducted at 6 community-based inpatient addiction treatment units. Units using the SP were randomly assigned at 14-week intervals to implement the RP. Participants admitted with OUD received the procedure the unit was delivering at the time of their admission. Participant recruitment took place between March 16, 2021, and July 18, 2022. The last visit was September 21, 2022.
UNASSIGNED: Standard procedure, based on the XR-naltrexone package insert (approximately 5-day buprenorphine taper followed by a 7- to 10-day opioid-free period and RP, defined as 1 day of buprenorphine at minimum necessary dose, 1 opioid-free day, and ascending low doses of oral naltrexone and adjunctive medications (eg, clonidine, clonazepam, antiemetics) for opioid withdrawal.
UNASSIGNED: Receipt of XR-naltrexone injection prior to inpatient discharge (primary outcome). Secondary outcomes included opioid withdrawal scores and targeted safety events and serious adverse events. All analyses were intention-to-treat.
UNASSIGNED: A total of 415 participants with OUD were enrolled (mean [SD] age, 33.6 [8.48] years; 205 [49.4%] identified sex as male); 54 [13.0%] individuals identified as Black, 91 [21.9%] as Hispanic, 290 [69.9%] as White, and 22 [5.3%] as multiracial. Rates of successful initiation of XR-naltrexone among the RP group (141 of 225 [62.7%]) were noninferior to those of the SP group (68 of 190 [35.8%]) (odds ratio [OR], 3.60; 95% CI, 2.12-6.10). Withdrawal did not differ significantly between conditions (proportion of days with a moderate or greater maximum Clinical Opiate Withdrawal Scale score (>12) for RP vs SP: OR, 1.25; 95% CI, 0.62-2.50). Targeted safety events (RP: 12 [5.3%]; SP: 4 [2.1%]) and serious adverse events (RP: 15 [6.7%]; SP: 3 [1.6%]) were infrequent but occurred more often with RP than SP.
UNASSIGNED: In this trial, the RP of XR-naltrexone initiation was noninferior to the standard approach and saved time, although it required more intensive medical management and safety monitoring. The results of this trial suggest that rapid initiation could make XR-naltrexone a more viable treatment for patients with OUD.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04762537.
UNASSIGNED: To compare the effectiveness of the standard procedure (SP) with the rapid procedure (RP) for XR-naltrexone initiation.
UNASSIGNED: The Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone study was an optimized stepped-wedge cluster randomized trial conducted at 6 community-based inpatient addiction treatment units. Units using the SP were randomly assigned at 14-week intervals to implement the RP. Participants admitted with OUD received the procedure the unit was delivering at the time of their admission. Participant recruitment took place between March 16, 2021, and July 18, 2022. The last visit was September 21, 2022.
UNASSIGNED: Standard procedure, based on the XR-naltrexone package insert (approximately 5-day buprenorphine taper followed by a 7- to 10-day opioid-free period and RP, defined as 1 day of buprenorphine at minimum necessary dose, 1 opioid-free day, and ascending low doses of oral naltrexone and adjunctive medications (eg, clonidine, clonazepam, antiemetics) for opioid withdrawal.
UNASSIGNED: Receipt of XR-naltrexone injection prior to inpatient discharge (primary outcome). Secondary outcomes included opioid withdrawal scores and targeted safety events and serious adverse events. All analyses were intention-to-treat.
UNASSIGNED: A total of 415 participants with OUD were enrolled (mean [SD] age, 33.6 [8.48] years; 205 [49.4%] identified sex as male); 54 [13.0%] individuals identified as Black, 91 [21.9%] as Hispanic, 290 [69.9%] as White, and 22 [5.3%] as multiracial. Rates of successful initiation of XR-naltrexone among the RP group (141 of 225 [62.7%]) were noninferior to those of the SP group (68 of 190 [35.8%]) (odds ratio [OR], 3.60; 95% CI, 2.12-6.10). Withdrawal did not differ significantly between conditions (proportion of days with a moderate or greater maximum Clinical Opiate Withdrawal Scale score (>12) for RP vs SP: OR, 1.25; 95% CI, 0.62-2.50). Targeted safety events (RP: 12 [5.3%]; SP: 4 [2.1%]) and serious adverse events (RP: 15 [6.7%]; SP: 3 [1.6%]) were infrequent but occurred more often with RP than SP.
UNASSIGNED: In this trial, the RP of XR-naltrexone initiation was noninferior to the standard approach and saved time, although it required more intensive medical management and safety monitoring. The results of this trial suggest that rapid initiation could make XR-naltrexone a more viable treatment for patients with OUD.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04762537.
摘要：
■可注射缓释（XR）-纳曲酮是阿片类药物使用障碍（OUD）的有效治疗选择，但需要在开始前将患者从阿片类药物治疗中撤出是实施的障碍.
■比较XR-纳曲酮起始的标准程序（SP）与快速程序（RP）的有效性。
■采用纳曲酮进行快速治疗的戒断试验是一项优化的阶梯式楔形整群随机试验，在6个社区住院成瘾治疗单位进行。使用SP的单位以14周的间隔随机分配以实施RP。参加OUD的参与者在入学时收到了该部门正在执行的程序。参与者招募于2021年3月16日至2022年7月18日之间进行。最后一次访问是2022年9月21日。
■标准程序，基于XR-纳曲酮包装说明书（大约5天的丁丙诺啡锥度，然后是7至10天的无阿片类药物期和RP，定义为在最低必要剂量下服用丁丙诺啡1天，1无阿片类药物日，和口服纳曲酮和辅助药物的低剂量递增（例如，可乐定,氯硝西泮,止吐药）用于阿片类药物戒断。
■出院前接受XR-纳曲酮注射（主要结果）。次要结果包括阿片类药物戒断评分、目标安全性事件和严重不良事件。所有分析均为意向治疗。
■共纳入了415名OUD患者(平均[SD]年龄，33.6[8.48]岁；205[49.4%]确定性别为男性）；54[13.0%]个人确定为黑人，91[21.9%]为西班牙裔，290[69.9%]为白色，22[5.3%]为多种族。RP组成功启动XR-纳曲酮的比率（225个中的141个[62.7％]）不劣于SP组（190个中的68个[35.8％]）（比值比[OR]，3.60；95%CI，2.12-6.10）。不同条件之间的戒断没有显着差异（RP与SP的中度或更大的最大临床阿片类戒断量表评分（>12）的天数比例：OR，1.25；95%CI，0.62-2.50）。目标安全性事件（RP：12[5.3%]；SP：4[2.1%]）和严重不良事件（RP：15[6.7%]；SP：3[1.6%]）不常见，但RP比SP更常见。
■在此试验中，XR-纳曲酮起始的RP不劣于标准方法，节省了时间，尽管它需要更深入的医疗管理和安全监控。该试验的结果表明，快速启动可以使XR-纳曲酮成为OUD患者更可行的治疗方法。
■ClinicalTrials.gov标识符：NCT04762537。
■比较XR-纳曲酮起始的标准程序（SP）与快速程序（RP）的有效性。
■采用纳曲酮进行快速治疗的戒断试验是一项优化的阶梯式楔形整群随机试验，在6个社区住院成瘾治疗单位进行。使用SP的单位以14周的间隔随机分配以实施RP。参加OUD的参与者在入学时收到了该部门正在执行的程序。参与者招募于2021年3月16日至2022年7月18日之间进行。最后一次访问是2022年9月21日。
■标准程序，基于XR-纳曲酮包装说明书（大约5天的丁丙诺啡锥度，然后是7至10天的无阿片类药物期和RP，定义为在最低必要剂量下服用丁丙诺啡1天，1无阿片类药物日，和口服纳曲酮和辅助药物的低剂量递增（例如，可乐定,氯硝西泮,止吐药）用于阿片类药物戒断。
■出院前接受XR-纳曲酮注射（主要结果）。次要结果包括阿片类药物戒断评分、目标安全性事件和严重不良事件。所有分析均为意向治疗。
■共纳入了415名OUD患者(平均[SD]年龄，33.6[8.48]岁；205[49.4%]确定性别为男性）；54[13.0%]个人确定为黑人，91[21.9%]为西班牙裔，290[69.9%]为白色，22[5.3%]为多种族。RP组成功启动XR-纳曲酮的比率（225个中的141个[62.7％]）不劣于SP组（190个中的68个[35.8％]）（比值比[OR]，3.60；95%CI，2.12-6.10）。不同条件之间的戒断没有显着差异（RP与SP的中度或更大的最大临床阿片类戒断量表评分（>12）的天数比例：OR，1.25；95%CI，0.62-2.50）。目标安全性事件（RP：12[5.3%]；SP：4[2.1%]）和严重不良事件（RP：15[6.7%]；SP：3[1.6%]）不常见，但RP比SP更常见。
■在此试验中，XR-纳曲酮起始的RP不劣于标准方法，节省了时间，尽管它需要更深入的医疗管理和安全监控。该试验的结果表明，快速启动可以使XR-纳曲酮成为OUD患者更可行的治疗方法。
■ClinicalTrials.gov标识符：NCT04762537。
