PDF(Pubmed)
Abstract：
UNASSIGNED: Fentanyl has exacerbated the opioid use disorder (OUD) and opioid overdose epidemic. Data on the effectiveness of medications for OUD among patients using fentanyl are limited.
UNASSIGNED: To assess the effectiveness of sublingual or extended-release injection formulations of buprenorphine for the treatment of OUD among patients with and without fentanyl use.
UNASSIGNED: Post hoc analysis of a 24-week, randomized, double-blind clinical trial conducted at 35 outpatient sites in the US from December 2015 to November 2016 of sublingual buprenorphine-naloxone vs extended-release subcutaneous injection buprenorphine (CAM2038) for patients with OUD subgrouped by presence vs absence of fentanyl or norfentanyl in urine at baseline. Study visits with urine testing occurred weekly for 12 weeks, then 6 times between weeks 13 and 24. Data were analyzed on an intention-to-treat basis from March 2022 to August 2023.
UNASSIGNED: Weekly and monthly subcutaneous buprenorphine vs daily sublingual buprenorphine-naloxone.
UNASSIGNED: Retention in treatment, percentage of urine samples negative for any opioids (missing values imputed as positive), percentage of urine samples negative for fentanyl or norfentanyl (missing values not imputed), and scores on opiate withdrawal scales and visual analog craving scales.
UNASSIGNED: Of 428 participants, 123 (subcutaneous buprenorphine, n = 64; sublingual buprenorphine-naloxone, n = 59; mean [SD] age, 39.1 [10.8] years; 75 men [61.0%]) had evidence of baseline fentanyl use and 305 (subcutaneous buprenorphine, n = 149; buprenorphine-naloxone, n = 156; mean [SD] age, 38.1 [11.1] years; 188 men [61.6%]) did not have evidence of baseline fentanyl use. Study completion was similar between the fentanyl-positive (60.2% [74 of 123]) and fentanyl-negative (56.7% [173 of 305]) subgroups. The mean percentage of urine samples negative for any opioid were 28.5% among those receiving subcutaneous buprenorphine and 18.8% among those receiving buprenorphine-naloxone in the fentanyl-positive subgroup (difference, 9.6%; 95% CI, -3.0% to 22.3%) and 36.7% among those receiving subcutaneous buprenorphine and 30.6% among those receiving buprenorphine-naloxone in the fentanyl-negative subgroup (difference, 6.1%; 95% CI, -1.9% to 14.1%), with significant main associations of baseline fentanyl status and treatment group. In the fentanyl-positive subgroup, the mean percentage of urine samples negative for fentanyl during the study was 74.6% among those receiving subcutaneous buprenorphine vs 61.9% among those receiving sublingual buprenorphine-naloxone (difference, 12.7%; 95% CI, 9.6%-15.9%). Opioid withdrawal and craving scores decreased rapidly after treatment initiation across all groups.
UNASSIGNED: In this post hoc analysis of a randomized clinical trial of sublingual vs extended-release injection buprenorphine for OUD, buprenorphine appeared to be effective among patients with baseline fentanyl use. Patients with fentanyl use had fewer opioid-negative urine samples during the trial compared with the fentanyl-negative subgroup. These findings suggest that the subcutaneous buprenorphine formulation may be more effective at reducing fentanyl use.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT02651584.
UNASSIGNED: To assess the effectiveness of sublingual or extended-release injection formulations of buprenorphine for the treatment of OUD among patients with and without fentanyl use.
UNASSIGNED: Post hoc analysis of a 24-week, randomized, double-blind clinical trial conducted at 35 outpatient sites in the US from December 2015 to November 2016 of sublingual buprenorphine-naloxone vs extended-release subcutaneous injection buprenorphine (CAM2038) for patients with OUD subgrouped by presence vs absence of fentanyl or norfentanyl in urine at baseline. Study visits with urine testing occurred weekly for 12 weeks, then 6 times between weeks 13 and 24. Data were analyzed on an intention-to-treat basis from March 2022 to August 2023.
UNASSIGNED: Weekly and monthly subcutaneous buprenorphine vs daily sublingual buprenorphine-naloxone.
UNASSIGNED: Retention in treatment, percentage of urine samples negative for any opioids (missing values imputed as positive), percentage of urine samples negative for fentanyl or norfentanyl (missing values not imputed), and scores on opiate withdrawal scales and visual analog craving scales.
UNASSIGNED: Of 428 participants, 123 (subcutaneous buprenorphine, n = 64; sublingual buprenorphine-naloxone, n = 59; mean [SD] age, 39.1 [10.8] years; 75 men [61.0%]) had evidence of baseline fentanyl use and 305 (subcutaneous buprenorphine, n = 149; buprenorphine-naloxone, n = 156; mean [SD] age, 38.1 [11.1] years; 188 men [61.6%]) did not have evidence of baseline fentanyl use. Study completion was similar between the fentanyl-positive (60.2% [74 of 123]) and fentanyl-negative (56.7% [173 of 305]) subgroups. The mean percentage of urine samples negative for any opioid were 28.5% among those receiving subcutaneous buprenorphine and 18.8% among those receiving buprenorphine-naloxone in the fentanyl-positive subgroup (difference, 9.6%; 95% CI, -3.0% to 22.3%) and 36.7% among those receiving subcutaneous buprenorphine and 30.6% among those receiving buprenorphine-naloxone in the fentanyl-negative subgroup (difference, 6.1%; 95% CI, -1.9% to 14.1%), with significant main associations of baseline fentanyl status and treatment group. In the fentanyl-positive subgroup, the mean percentage of urine samples negative for fentanyl during the study was 74.6% among those receiving subcutaneous buprenorphine vs 61.9% among those receiving sublingual buprenorphine-naloxone (difference, 12.7%; 95% CI, 9.6%-15.9%). Opioid withdrawal and craving scores decreased rapidly after treatment initiation across all groups.
UNASSIGNED: In this post hoc analysis of a randomized clinical trial of sublingual vs extended-release injection buprenorphine for OUD, buprenorphine appeared to be effective among patients with baseline fentanyl use. Patients with fentanyl use had fewer opioid-negative urine samples during the trial compared with the fentanyl-negative subgroup. These findings suggest that the subcutaneous buprenorphine formulation may be more effective at reducing fentanyl use.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT02651584.
摘要：
■芬太尼加剧了阿片类药物使用障碍（OUD）和阿片类药物过量流行。使用芬太尼的患者中OUD药物有效性的数据有限。
■评估丁丙诺啡舌下或缓释注射制剂在使用和不使用芬太尼的患者中治疗OUD的有效性。
■对24周的事后分析，随机化，2015年12月至2016年11月,在美国35个门诊地点进行了舌下含服丁丙诺啡-纳洛酮与缓释皮下注射丁丙诺啡(CAM2038)治疗OUD患者的双盲临床试验,其中OUD患者的基线时存在芬太尼或无芬太尼.为期12周，每周进行一次尿检的研究访视，然后在第13周和第24周之间进行6次。数据在2022年3月至2023年8月的意向治疗基础上进行了分析。
■每周和每月皮下丁丙诺啡与每日舌下丁丙诺啡-纳洛酮的比较。
■保留治疗，任何阿片类药物阴性的尿液样本百分比(缺失值估计为阳性)，芬太尼或降芬太尼阴性的尿液样本百分比（未估算的缺失值），以及鸦片戒断量表和视觉模拟渴望量表的分数。
■在428名参与者中，123(皮下丁丙诺啡，n=64；舌下丁丙诺啡-纳洛酮，n=59；平均[SD]年龄，39.1[10.8]年;75名男性[61.0%])有基线芬太尼使用的证据和305(皮下丁丙诺啡，n=149；丁丙诺啡-纳洛酮，n=156；平均[SD]年龄，38.1[11.1]年；188名男性[61.6％]）没有基线芬太尼使用的证据。芬太尼阳性（60.2%[74/123]）和芬太尼阴性（56.7%[173/305]）亚组的研究完成情况相似。在芬太尼阳性亚组中，任何阿片类药物阴性的尿液样本的平均百分比在接受皮下丁丙诺啡的患者中为28.5％，在接受丁丙诺啡-纳洛酮的患者中为18.8％（差异，9.6％；95％CI，-3.0％至22.3％），芬太尼阴性亚组中接受皮下丁丙诺啡的患者为36.7％，接受丁丙诺啡-纳洛酮的患者为30.6％（差异，6.1%；95%CI，-1.9%至14.1%），基线芬太尼状态和治疗组之间存在显着主要关联。在芬太尼阳性亚组中，研究期间芬太尼阴性的尿液样本的平均百分比在接受皮下丁丙诺啡的患者中为74.6%，在接受舌下丁丙诺啡-纳洛酮的患者中为61.9%（差异，12.7%；95%CI，9.6%-15.9%）。所有组的阿片类药物戒断和渴望评分在治疗开始后迅速下降。
■在对舌下注射丁丙诺啡治疗OUD的一项随机临床试验的事后分析中，在基线使用芬太尼的患者中,丁丙诺啡似乎是有效的.与芬太尼阴性亚组相比，使用芬太尼的患者在试验期间的阿片类药物阴性尿液样本较少。这些发现表明，皮下丁丙诺啡制剂可能更有效地减少芬太尼的使用。
■ClinicalTrials.gov标识符：NCT02651584。
■评估丁丙诺啡舌下或缓释注射制剂在使用和不使用芬太尼的患者中治疗OUD的有效性。
■对24周的事后分析，随机化，2015年12月至2016年11月,在美国35个门诊地点进行了舌下含服丁丙诺啡-纳洛酮与缓释皮下注射丁丙诺啡(CAM2038)治疗OUD患者的双盲临床试验,其中OUD患者的基线时存在芬太尼或无芬太尼.为期12周，每周进行一次尿检的研究访视，然后在第13周和第24周之间进行6次。数据在2022年3月至2023年8月的意向治疗基础上进行了分析。
■每周和每月皮下丁丙诺啡与每日舌下丁丙诺啡-纳洛酮的比较。
■保留治疗，任何阿片类药物阴性的尿液样本百分比(缺失值估计为阳性)，芬太尼或降芬太尼阴性的尿液样本百分比（未估算的缺失值），以及鸦片戒断量表和视觉模拟渴望量表的分数。
■在428名参与者中，123(皮下丁丙诺啡，n=64；舌下丁丙诺啡-纳洛酮，n=59；平均[SD]年龄，39.1[10.8]年;75名男性[61.0%])有基线芬太尼使用的证据和305(皮下丁丙诺啡，n=149；丁丙诺啡-纳洛酮，n=156；平均[SD]年龄，38.1[11.1]年；188名男性[61.6％]）没有基线芬太尼使用的证据。芬太尼阳性（60.2%[74/123]）和芬太尼阴性（56.7%[173/305]）亚组的研究完成情况相似。在芬太尼阳性亚组中，任何阿片类药物阴性的尿液样本的平均百分比在接受皮下丁丙诺啡的患者中为28.5％，在接受丁丙诺啡-纳洛酮的患者中为18.8％（差异，9.6％；95％CI，-3.0％至22.3％），芬太尼阴性亚组中接受皮下丁丙诺啡的患者为36.7％，接受丁丙诺啡-纳洛酮的患者为30.6％（差异，6.1%；95%CI，-1.9%至14.1%），基线芬太尼状态和治疗组之间存在显着主要关联。在芬太尼阳性亚组中，研究期间芬太尼阴性的尿液样本的平均百分比在接受皮下丁丙诺啡的患者中为74.6%，在接受舌下丁丙诺啡-纳洛酮的患者中为61.9%（差异，12.7%；95%CI，9.6%-15.9%）。所有组的阿片类药物戒断和渴望评分在治疗开始后迅速下降。
■在对舌下注射丁丙诺啡治疗OUD的一项随机临床试验的事后分析中，在基线使用芬太尼的患者中,丁丙诺啡似乎是有效的.与芬太尼阴性亚组相比，使用芬太尼的患者在试验期间的阿片类药物阴性尿液样本较少。这些发现表明，皮下丁丙诺啡制剂可能更有效地减少芬太尼的使用。
■ClinicalTrials.gov标识符：NCT02651584。
