Department of Internal Medicine, Gyeongsang National University College of Medicine, Jinju, Korea.
Department of Hematology-Oncology, Yeungnam University College of Medicine, Daegu, Korea.
Oncologist. 2024 Nov 4;29(11):e1593-e1603. doi: 10.1093/oncolo/oyae176.
The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies.
This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety.
Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms.
TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable.
癌症幸存者对处方类阿片的身体依赖仍是一个研究不足的领域,缺乏精心设计的前瞻性研究。
本项在韩国开展的单臂、2 期临床试验评估了经皮丁丙诺啡贴片(TBP)治疗癌症幸存者处方类阿片身体依赖的疗效和安全性,该研究通过 DSM-5 标准或精神科咨询来确认阿片类药物戒断。该研究包括 4 个阶段的治疗方案:筛选、诱导/稳定、停药和监测。主要结局是 8 周时尿药物检测阴性的阿片类药物停药成功率。关键次要结局包括恢复规定剂量的阿片类药物、临床阿片类戒断量表(COWS)和吗啡等效日剂量(MEDD)的变化,以及与依赖的心理和生理方面及安全性相关的评估。
共纳入 31 名参与者。在意向治疗人群中,阿片类药物停药成功率为 58%,仅 2 名参与者恢复使用规定剂量的阿片类药物。MEDD 从 98 降至 26 mg/天(P<0.001),COWS 评分从 5.5 降至 2.8(P<0.001),均有显著降低。10 分制数字评分量表上对使用阿片类药物的渴望从 7.0 降至 3.0(P<0.001)。TBP 相关毒性轻微且可管理,无严重的戒断症状。
TBP 可作为癌症幸存者对处方类阿片药物身体依赖的替代治疗选择,尤其是舌下制剂不可及的情况下。