Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone Soluble-Films
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone Soluble-Films
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DOI：
10.1038/clpt.2010.352
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发表时间：
2011-03-01
影响因子：
6.7
通讯作者：
Bigelow, G. E.
中科院分区：
文献类型：
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作者：
Strain, E. C.;Harrison, J. A.;Bigelow, G. E.
丁丙诺啡/纳洛酮 (B/N) 舌下可溶膜制剂已获得美国食品和药物管理局批准用于治疗阿片类药物依赖。该制剂提供单位剂量、儿童安全包装，易于跟踪和问责，溶解速度更快，并且与片剂相比具有潜在的首选口味。本研究比较了丁丙诺啡 (B) 和 B/N 膜抑制阿片类药物依赖志愿者自发戒断的能力。参与者继续服用吗啡并接受挑战课程，以确认对纳洛酮诱导的阿片类药物戒断的敏感性。受试者随机接受 B（16 毫克，n = 18）或 B/N（16/4 毫克，n = 16）可溶性薄膜，为期 5 天。主要结果指标是临床阿片戒断量表（COWS）评分。三十四名受试者完成了可溶膜上的诱导。 COWS 分数显着下降，但各组之间没有显着差异。结果支持使用 B 和 B/N 可溶性薄膜作为阿片类药物诱导的安全有效的递送方法。
A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency. This preparation provides unit-dose, child-resistant packaging amenable to tracking and accountability, offers more rapid dissolution, and has a potentially preferred taste vs. tablets. This study compared the ability of buprenorphine (B) and B/N films to suppress spontaneous withdrawal in opioid-dependent volunteers. Participants were maintained on morphine and underwent challenge sessions to confirm sensitivity to naloxone-induced opioid withdrawal. Subjects were randomized to receive either B (16 mg, n = 18) or B/N (16/4 mg, n = 16) soluble films for 5 days. The primary outcome measure was the Clinical Opiate Withdrawal Scale (COWS) score. Thirty-four subjects completed induction onto soluble films. There was a significant decrease in COWS scores but no significant differences between the groups. The results support the use of B and B/N soluble films as safe and effective delivery methods for opioid induction.