PDF(Pubmed)
Abstract：
UNASSIGNED: Buprenorphine is an effective yet underused treatment for opioid use disorder (OUD).
UNASSIGNED: To evaluate the feasibility (acceptability, tolerability, and safety) of 7-day injectable extended-release buprenorphine in patients with minimal to mild opioid withdrawal.
UNASSIGNED: This nonrandomized trial comprising 4 emergency departments in the Northeast, mid-Atlantic, and Pacific geographic areas of the US included adults aged 18 years or older with moderate to severe OUD and Clinical Opiate Withdrawal Scale (COWS) scores less than 8 (minimal to mild), in which scores range from 0 to 7, with higher scores indicating increasing withdrawal. Exclusion criteria included methadone-positive urine, pregnancy, overdose, or required admission. Outcomes were assessed at baseline, daily for 7 days by telephone surveys, and in person at 7 days. Patient recruitment occurred between July 13, 2020, and May 25, 2023.
UNASSIGNED: Injection of a 24-mg dose of a weekly extended-release formulation of buprenorphine (CAM2038) and referral for ongoing OUD care.
UNASSIGNED: Primary feasibility outcomes included the number of patients who (1) experienced a 5-point or greater increase in the COWS score or (2) transitioned to moderate or greater withdrawal (COWS score ≥13) within 4 hours of extended-release buprenorphine or (3) experienced precipitated withdrawal within 1 hour of extended-release buprenorphine. Secondary outcomes included injection pain, satisfaction, craving, use of nonprescribed opioids, adverse events, and engagement in OUD treatment.
UNASSIGNED: A total of 100 adult patients were enrolled (mean [SD] age, 36.5 [8.7] years; 72% male). Among the patients, 10 (10.0% [95% CI, 4.9%-17.6%]) experienced a 5-point or greater increase in COWS and 7 (7.0% [95% CI, 2.9%-13.9%]) transitioned to moderate or greater withdrawal within 4 hours, and 2 (2.0% [95% CI, 0.2%-7.0%]) experienced precipitated withdrawal within 1 hour of extended-release buprenorphine. A total of 7 patients (7.0% [95% CI, 2.9%-13.9%]) experienced precipitated withdrawal within 4 hours of extended-release buprenorphine, which included 2 of 63 (3.2%) with a COWS score of 4 to 7 and 5 of 37 (13.5%) with a COWS score of 0 to 3. Site pain scores (based on a total pain score of 10, in which 0 indicated no pain and 10 was the worst possible pain) after injection were low immediately (median, 2.0; range, 0-10.0) and after 4 hours (median, 0; range, 0-10.0). On any given day among those who responded, between 29 (33%) and 31 (43%) patients reported no cravings and between 59 (78%) and 75 (85%) reported no use of opioids; 57 patients (60%) reported no days of opioid use. Improving privacy (62%) and not requiring daily medication (67%) were deemed extremely important. Seventy-three patients (73%) were engaged in OUD treatment on day 7. Five serious adverse events occurred that required hospitalization, of which 2 were associated with medication.
UNASSIGNED: This nonrandomized trial of the feasibility of a 7-day buprenorphine injectable in patients with minimal to mild opioid withdrawal (COWS scores, 0-7) found the formulation to be acceptable, well tolerated, and safe in those with COWS scores of 4 to 7. This new medication formulation could substantially increase the number of patients with OUD receiving buprenorphine.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04225598.
UNASSIGNED: To evaluate the feasibility (acceptability, tolerability, and safety) of 7-day injectable extended-release buprenorphine in patients with minimal to mild opioid withdrawal.
UNASSIGNED: This nonrandomized trial comprising 4 emergency departments in the Northeast, mid-Atlantic, and Pacific geographic areas of the US included adults aged 18 years or older with moderate to severe OUD and Clinical Opiate Withdrawal Scale (COWS) scores less than 8 (minimal to mild), in which scores range from 0 to 7, with higher scores indicating increasing withdrawal. Exclusion criteria included methadone-positive urine, pregnancy, overdose, or required admission. Outcomes were assessed at baseline, daily for 7 days by telephone surveys, and in person at 7 days. Patient recruitment occurred between July 13, 2020, and May 25, 2023.
UNASSIGNED: Injection of a 24-mg dose of a weekly extended-release formulation of buprenorphine (CAM2038) and referral for ongoing OUD care.
UNASSIGNED: Primary feasibility outcomes included the number of patients who (1) experienced a 5-point or greater increase in the COWS score or (2) transitioned to moderate or greater withdrawal (COWS score ≥13) within 4 hours of extended-release buprenorphine or (3) experienced precipitated withdrawal within 1 hour of extended-release buprenorphine. Secondary outcomes included injection pain, satisfaction, craving, use of nonprescribed opioids, adverse events, and engagement in OUD treatment.
UNASSIGNED: A total of 100 adult patients were enrolled (mean [SD] age, 36.5 [8.7] years; 72% male). Among the patients, 10 (10.0% [95% CI, 4.9%-17.6%]) experienced a 5-point or greater increase in COWS and 7 (7.0% [95% CI, 2.9%-13.9%]) transitioned to moderate or greater withdrawal within 4 hours, and 2 (2.0% [95% CI, 0.2%-7.0%]) experienced precipitated withdrawal within 1 hour of extended-release buprenorphine. A total of 7 patients (7.0% [95% CI, 2.9%-13.9%]) experienced precipitated withdrawal within 4 hours of extended-release buprenorphine, which included 2 of 63 (3.2%) with a COWS score of 4 to 7 and 5 of 37 (13.5%) with a COWS score of 0 to 3. Site pain scores (based on a total pain score of 10, in which 0 indicated no pain and 10 was the worst possible pain) after injection were low immediately (median, 2.0; range, 0-10.0) and after 4 hours (median, 0; range, 0-10.0). On any given day among those who responded, between 29 (33%) and 31 (43%) patients reported no cravings and between 59 (78%) and 75 (85%) reported no use of opioids; 57 patients (60%) reported no days of opioid use. Improving privacy (62%) and not requiring daily medication (67%) were deemed extremely important. Seventy-three patients (73%) were engaged in OUD treatment on day 7. Five serious adverse events occurred that required hospitalization, of which 2 were associated with medication.
UNASSIGNED: This nonrandomized trial of the feasibility of a 7-day buprenorphine injectable in patients with minimal to mild opioid withdrawal (COWS scores, 0-7) found the formulation to be acceptable, well tolerated, and safe in those with COWS scores of 4 to 7. This new medication formulation could substantially increase the number of patients with OUD receiving buprenorphine.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04225598.
摘要：
■丁丙诺啡是一种有效但未被充分利用的阿片类药物使用障碍（OUD）的治疗方法。
■为了评估可行性(可接受性，耐受性,和安全性）在最小至轻度阿片类药物戒断的患者中使用7天注射缓释丁丙诺啡。
■这项由东北部4个急诊科组成的非随机试验，大西洋中部,美国的太平洋地理区域包括18岁或以上的成年人，其中中度至重度OUD和临床阿片类药物戒断量表（COWS）得分低于8（最小至轻度），其中得分范围从0到7，得分越高表明退出增加。排除标准包括美沙酮阳性尿液，怀孕,用药过量,或要求入场。结果在基线评估，每天7天通过电话调查，在7天的人。患者招募发生在2020年7月13日至2023年5月25日之间。
■每周注射24毫克剂量的丁丙诺啡缓释制剂（CAM2038），并转诊以进行OUD护理。
■主要可行性结果包括：(1)在丁丙诺啡延长释放后4小时内，出现COWS评分增加5分或更多，或(2)转为中度或更高戒断（COWS评分≥13），或(3)丁丙诺啡延长释放后1小时内出现沉淀戒断的患者人数。次要结果包括注射疼痛，满意,渴望,使用非处方阿片类药物，不良事件,并参与OUD治疗。
■总共招募了100名成年患者（平均[SD]年龄，36.5[8.7]岁；72%男性）。在患者中,10（10.0％[95％CI，4.9％-17.6％]）的COWS增加了5点或更高，7（7.0％[95％CI，2.9％-13.9％]）在4小时内过渡到中度或更高的戒断，和2（2.0%[95%CI，0.2%-7.0%]）在丁丙诺啡缓释1小时内出现沉淀戒断。共有7例患者（7.0%[95%CI,2.9%-13.9%]）在丁丙诺啡缓释4小时内出现沉淀戒断，其中包括COWS评分为4至7分的63人中的2人(3.2%)和COWS评分为0至3分的37人中的5人(13.5%).注射后的部位疼痛评分（基于10的总疼痛评分，其中0表示没有疼痛，10表示最严重的疼痛）立即较低（中位数，2.0;范围,0-10.0）和4小时后（中位数，0;范围,0-10.0）。在任何一天，在那些回应的人中，29例(33%)-31例(43%)患者报告无阿片类药物的使用渴望,59例(78%)-75例(85%)患者报告无阿片类药物使用天数;57例(60%)患者报告无阿片类药物使用天数.改善隐私（62％）和不需要日常药物治疗（67％）被认为极为重要。在第7天，有73名患者（73％）接受了OUD治疗。发生了5起需要住院治疗的严重不良事件，其中2个与药物治疗有关。
■这项非随机试验研究了7天丁丙诺啡注射剂在最低至轻度阿片类药物戒断患者中的可行性（COWS评分，0-7)发现配方是可以接受的，良好的耐受性，在COWS评分为4到7的人群中也是安全的。这种新的药物配方可以大大增加接受丁丙诺啡的OUD患者的数量。
■ClinicalTrials.gov标识符：NCT04225598。
■为了评估可行性(可接受性，耐受性,和安全性）在最小至轻度阿片类药物戒断的患者中使用7天注射缓释丁丙诺啡。
■这项由东北部4个急诊科组成的非随机试验，大西洋中部,美国的太平洋地理区域包括18岁或以上的成年人，其中中度至重度OUD和临床阿片类药物戒断量表（COWS）得分低于8（最小至轻度），其中得分范围从0到7，得分越高表明退出增加。排除标准包括美沙酮阳性尿液，怀孕,用药过量,或要求入场。结果在基线评估，每天7天通过电话调查，在7天的人。患者招募发生在2020年7月13日至2023年5月25日之间。
■每周注射24毫克剂量的丁丙诺啡缓释制剂（CAM2038），并转诊以进行OUD护理。
■主要可行性结果包括：(1)在丁丙诺啡延长释放后4小时内，出现COWS评分增加5分或更多，或(2)转为中度或更高戒断（COWS评分≥13），或(3)丁丙诺啡延长释放后1小时内出现沉淀戒断的患者人数。次要结果包括注射疼痛，满意,渴望,使用非处方阿片类药物，不良事件,并参与OUD治疗。
■总共招募了100名成年患者（平均[SD]年龄，36.5[8.7]岁；72%男性）。在患者中,10（10.0％[95％CI，4.9％-17.6％]）的COWS增加了5点或更高，7（7.0％[95％CI，2.9％-13.9％]）在4小时内过渡到中度或更高的戒断，和2（2.0%[95%CI，0.2%-7.0%]）在丁丙诺啡缓释1小时内出现沉淀戒断。共有7例患者（7.0%[95%CI,2.9%-13.9%]）在丁丙诺啡缓释4小时内出现沉淀戒断，其中包括COWS评分为4至7分的63人中的2人(3.2%)和COWS评分为0至3分的37人中的5人(13.5%).注射后的部位疼痛评分（基于10的总疼痛评分，其中0表示没有疼痛，10表示最严重的疼痛）立即较低（中位数，2.0;范围,0-10.0）和4小时后（中位数，0;范围,0-10.0）。在任何一天，在那些回应的人中，29例(33%)-31例(43%)患者报告无阿片类药物的使用渴望,59例(78%)-75例(85%)患者报告无阿片类药物使用天数;57例(60%)患者报告无阿片类药物使用天数.改善隐私（62％）和不需要日常药物治疗（67％）被认为极为重要。在第7天，有73名患者（73％）接受了OUD治疗。发生了5起需要住院治疗的严重不良事件，其中2个与药物治疗有关。
■这项非随机试验研究了7天丁丙诺啡注射剂在最低至轻度阿片类药物戒断患者中的可行性（COWS评分，0-7)发现配方是可以接受的，良好的耐受性，在COWS评分为4到7的人群中也是安全的。这种新的药物配方可以大大增加接受丁丙诺啡的OUD患者的数量。
■ClinicalTrials.gov标识符：NCT04225598。
