Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder
Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder
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DOI：
10.1111/add.14636
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发表时间：
2019-08-01
期刊：
影响因子：
6
通讯作者：
Tiberg, Fredrik
中科院分区：
文献类型：
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作者：
Frost, Michael;Bailey, Genie L.;Tiberg, Fredrik
目的评价丁丙诺啡（CAM2038）周、月皮下滴注的长期安全性。设计3期，开放标签，观察性，多中心48周试验（NCT02672111）。在2015年12月14日至2017年4月12日期间设置26个门诊点（美国、英国、匈牙利、丹麦、瑞典、德国、澳大利亚）。参与者：228名成人阿片类药物使用障碍患者；227人接受CAM2038治疗（37人开始使用CAM2038治疗，190人从丁丙诺啡舌下治疗转为使用CAM2038治疗）。干预措施CAM2038每周（8、16、24或32毫克）或每月（64、96、128或160毫克），采用灵活的剂量和个体化滴定，使用多次CAM2038每周和每月剂量。每次访问时收集安全变量、尿液毒理学样本和自我报告的非法阿片类药物使用情况。参与者在第6个月和第12个月进行了患者满意度调查，227名参与者中有162名（71.4%）完成了调查。研究结果：227名参与者中有167名（73.6%）完成了研究治疗期。227名参与者中有143名（63.0%）报告了至少一次治疗引起的不良事件（TEAE），其中227名参与者中有60名（26.4%）报告与药物有关。227名参与者中有128名（56.4%）报告了大多数teae，强度为轻度或中度。227名参与者中有46名（20.3%）报告了注射部位反应，其中大多数（46名中的45名（97.8%））报告为轻度至中度。5名参与者（2.2%）因TEAE而停用研究药物，其中2例（0.9%）与注射部位相关。研究药物未发生严重不良事件。在剩余的研究中，阿片类药物尿液检测阴性并自我报告的百分比在新接受治疗的参与者中为63.0%（27人中的17人），在从舌下丁丙诺啡转换的参与者中为82.8%（134人中的111人）。参与者对CAM2038报告了很高的满意度。结论每周或每月皮下丁丙诺啡（CAM2038）耐受性良好，全身安全性与已知的舌下丁丙诺啡一致。在本研究中，CAM2038每周和每月与高保留率和低非法阿片类药物使用水平相关。
Aims To assess the long-term safety of subcutaneous buprenorphine (CAM2038) weekly and monthly depots. Design Phase 3, open-label, observational, multi-centre 48-week trial ( NCT02672111). Setting Twenty-six out-patient sites (United States, United Kingdom, Hungary, Denmark, Sweden, Germany, Australia) between 14 December 2015 and 12 April 2017. Participants Two hundred and twenty-eight adults with opioid use disorder; 227 received CAM2038 (37 initiated onto CAM2038 and 190 converted from sublingual buprenorphine). Interventions CAM2038 weekly (8, 16, 24 or 32 mg) or monthly (64, 96, 128 or 160 mg) with flexible dosing and individualized titration utilizing multiple CAM2038 weekly and monthly doses. Measurements Safety variables, urine toxicology samples and self-reported illicit opioid use were collected at each visit. Participants were administered a patient satisfaction survey at months 6 and 12, completed by 162 of 227 (71.4%) participants. Findings The study treatment period was completed by 167 of 227 (73.6%) participants. At least one treatment-emergent adverse event (TEAE) was reported by 143 of 227 (63.0%) participants, of whom 60 of 227 (26.4%) reported as being drug-related. Most of the TEAEs, reported by 128 of 227 (56.4%) of participants, were mild or moderate in intensity. Injection-site reactions were reported by 46 of 227 (20.3%) participants, with most [45 of 46 (97.8%)] reported as mild to moderate. Five participants (2.2%) discontinued the study drug due to a TEAE, two cases (0.9%) of which were injection-site-related. No serious adverse events were attributed to the study drug. Among those remaining in the study, the percentage of opioid-negative urine tests combined with self-reports was 63.0% (17 of 27) in new-to-treatment participants and 82.8% (111 of 134) for those converted from sublingual buprenorphine. Participants reported high levels of satisfaction with CAM2038. Conclusions Subcutaneous buprenorphine delivered weekly or monthly (CAM2038) was well tolerated, with a systemic safety profile consistent with the known profile of sublingual buprenorphine. CAM2038 weekly and monthly was associated with high retention rates and low levels of illicit opioid use throughout this study.