The Frost Medical Group, LLC, Conshohocken, PA, USA.
Warren Alpert Medical School of Brown University, Providence, RI, USA.
Addiction. 2019 Aug;114(8):1416-1426. doi: 10.1111/add.14636. Epub 2019 Jun 3.
To assess the long-term safety of subcutaneous buprenorphine (CAM2038) weekly and monthly depots.
Phase 3, open-label, observational, multi-centre 48-week trial (ClinicalTrials.gov NCT02672111).
Twenty-six out-patient sites (United States, United Kingdom, Hungary, Denmark, Sweden, Germany, Australia) between 14 December 2015 and 12 April 2017.
Two hundred and twenty-eight adults with opioid use disorder; 227 received CAM2038 (37 initiated onto CAM2038 and 190 converted from sublingual buprenorphine).
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.
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.
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.
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.
评估皮下丁丙诺啡（CAM2038）每周和每月给药的长期安全性。
为期 48 周的 3 期、开放标签、观察性、多中心试验（ClinicalTrials.gov NCT02672111）。
2015 年 12 月 14 日至 2017 年 4 月 12 日期间，美国、英国、匈牙利、丹麦、瑞典、德国和澳大利亚的 26 个门诊点。
228 名患有阿片类药物使用障碍的成年人；227 人接受了 CAM2038（37 人开始使用 CAM2038，190 人从舌下丁丙诺啡转为使用 CAM2038）。
CAM2038 每周（8、16、24 或 32mg）或每月（64、96、128 或 160mg）给药，剂量灵活，个体化滴定，使用多种 CAM2038 每周和每月剂量。
在每次就诊时收集安全性变量、尿液毒理学样本和自我报告的非法阿片类药物使用情况。在第 6 个月和第 12 个月，对 227 名参与者中的 162 名（71.4%）进行了患者满意度调查，其中 162 名（71.4%）完成了调查。
167 名参与者（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 1 次治疗后出现的不良事件（TEAE），其中 60 名（26.4%）报告与药物有关。大多数 TEAEs（227 名参与者中的 128 名，占 56.4%）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 45 名（97.8%）报告为轻度至中度。有 5 名参与者（2.2%）因 TEAEs 而停止使用研究药物，其中 2 例（0.9%）与注射部位有关。没有严重不良事件与研究药物有关。在继续参与研究的参与者中，新治疗参与者中阿片类药物阴性尿液检测与自我报告相结合的比例为 63.0%（17/27），舌下丁丙诺啡转换过来的参与者为 82.8%（111/134）。参与者对 CAM2038 的满意度很高。
皮下丁丙诺啡（CAM2038）每周或每月给药耐受性良好，其全身安全性与已知的舌下丁丙诺啡安全性一致。在整个研究过程中，CAM2038 每周和每月给药与高保留率和低非法阿片类药物使用量相关。
