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首页> 外文期刊>Clinical drug investigation >Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced non-dependent opioid users: a randomized, double-blind, placebo-controlled, crossover study.
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Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced non-dependent opioid users: a randomized, double-blind, placebo-controlled, crossover study.

机译：在经验丰富的非依赖性阿片类药物使用者中，硫酸吗啡和盐酸纳曲酮全缓释胶囊和盐酸纳曲酮（ALO-01）缓释胶囊与吗啡溶液和安慰剂的主观效果和安全性：一项随机，双盲，安慰剂对照的交叉研究。

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BACKGROUND AND OBJECTIVE: Given the dual public health challenges of undertreated pain and opioid abuse, there is a need to reduce attractiveness of opioid analgesics to drug abusers. ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules, indicated for treatment of chronic, moderate to severe pain, contain polymer-coated pellets of morphine, each with a core of sequestered naltrexone intended for release only upon tampering (crushing). The purpose of this study was to assess the pharmacodynamic effects (including drug-liking and euphoria) of whole and crushed ALO-01 versus morphine sulfate solution (MSS) and placebo. METHODS: This was a randomized, double-blind, placebo-controlled, triple-dummy, four-way crossover study carried out at a clinical research centre. Participants were experienced non-dependent opioid users. Subjects were given either two ALO-01 60 mg capsules, crushed pellets from two ALO-01 60 mg capsules, MSS 120 mg or placebo; there was a 14- to 21-day washout between treatments. The primary endpoints were drug-liking visual analogue scale score, scores on items from the Addiction Research Center Inventory (ARCI) and Cole/ARCI scales characterizing abuse potential and euphoria, and pupil diameter as measured by pupillometry. RESULTS: Morphine plasma concentrations were similar after ALO-01 crushed and MSS, with a median time to reach maximum plasma concentration (t(max)) of 1.1 and 1.2 hours, respectively; the plasma naltrexone median t(max) was 1.1 hours after ALO-01 crushed. By comparison, the median t(max) for morphine with ALO-01 whole was 8.1 hours. The maximum effect (E(max)) of MSS was significantly greater than placebo on pupillometry and the subjective measures (all p < 0.001). ALO-01 whole and crushed produced lower E(max) values and flatter effect-time profiles for subjective measures and caused less pupillary constriction than MSS. CONCLUSION: The results of this study demonstrated that ALO-01, whether taken orally whole as intended or tampered with by crushing and taken orally, had reduced desirability compared with MSS.
机译：背景与目的：鉴于疼痛不足和阿片类药物滥用对公共健康的双重挑战，有必要降低阿片类镇痛药对吸毒者的吸引力。 ALO-01（硫酸吗啡和盐酸纳曲酮）缓释胶囊，用于治疗慢性，中度至重度疼痛，含有聚合物包衣的吗啡药丸，每个药丸都有隔离的纳曲酮核，仅在篡改（压碎）时释放。这项研究的目的是评估整体和压碎的ALO-01与硫酸吗啡溶液（MSS）和安慰剂的药效学作用（包括喜药和欣快感）。方法：这是在临床研究中心进行的一项随机，双盲，安慰剂对照，三重虚拟，四向交叉研究。参与者是经验丰富的非依赖性阿片类药物使用者。给予受试者两个ALO-01 60 mg胶囊，两个ALO-01 60 mg胶囊压碎的小丸，MSS 120 mg或安慰剂。治疗之间有14到21天的洗脱时间。主要终点是喜欢药物的视觉模拟量表评分，成瘾研究中心库存（ARCI）项目得分和表征滥用可能性和欣快感的Cole / ARCI量表以及通过瞳孔测量法测量的瞳孔直径。结果：ALO-01压碎和MSS后的吗啡血浆浓度相似，达到最大血浆浓度（t（max））的中位时间分别为1.1小时和1.2小时。 ALO-01压碎后，血浆纳曲酮中值t（max）为1.1小时。相比之下，整个ALO-01的吗啡的中位t（max）为8.1小时。 MSS对瞳孔测量和主观测量的最大作用（E（max））明显大于安慰剂（所有p <0.001）。整体和压碎的ALO-01产生的E（max）值较低，而主观测量的作用时间曲线更平坦，与MSS相比，引起的瞳孔缩小更少。结论：本研究结果表明，与MSS相比，ALO-01不论是按预期口服全部食用还是经压碎捣碎并口服服用，均具有降低的理想性。

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