Abstract

Background

Silexan is a lavender essential oil with established anxiolytic and calming efficacy. Here we asked whether there is a potential for abuse in human patients.

Methods

We carried out a phase I abuse liability single-center, double-blind, 5-way crossover study in healthy users of recreational central nervous system depressants. They received single oral doses of 80 mg (therapeutic dose) and 640 mg Silexan, 2 mg and 4 mg lorazepam (active control) and placebo in randomized order, with 4- to 14-day washout periods between treatments. Pharmacodynamic measures included validated visual analogue scales assessing positive, negative, and sedative drug effects and balance of effects; a short form of the Addiction Research Center Inventory; and a drug similarity assessment. The primary outcome measure was the individual maximum value on the drug liking visual analogue scale during 24 hours post-dose.

Results

Forty participants were randomized and 34 were evaluable for pharmacodynamic outcomes. In intraindividual head-to-head comparisons of the drug liking visual analogue scale maximum value, both doses of Silexan were rated similar to placebo whereas differences were observed between Silexan and lorazepam and between placebo and lorazepam (P < .001). These data were supported by all secondary measures of positive drug effects and of balance of effects. Differences between placebo and both doses of Silexan were always negligible in magnitude. Moreover, Silexan showed no sedative effects and was not perceived to be similar to commonly used drugs that participants had used in the past.

Conclusions

Silexan did not exhibit any abuse potential in a standard abuse potential detection screen study and is unlikely to be recreationally abused.

中文翻译：

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Silexan 在健康消遣性吸毒者中没有滥用潜力：一项随机对照试验

摘要

背景

Silexan 是一种薰衣草精油，具有公认的抗焦虑和镇静功效。在这里，我们询问人类患者是否存在滥用的可能性。

方法

我们对娱乐性中枢神经系统抑制剂的健康使用者进行了一项 I 期滥用责任单中心、双盲、5 路交叉研究。他们以随机顺序接受 80 毫克（治疗剂量）和 640 毫克 Silexan、2 毫克和 4 毫克劳拉西泮（活性对照）和安慰剂的单次口服剂量，治疗之间有 4 至 14 天的清除期。药效学测量包括经过验证的视觉模拟量表，用于评估阳性、阴性和镇静药物作用以及作用平衡；成瘾研究中心清单的简短形式；和药物相似性评估。主要结果测量是给药后 24 小时内药物喜好视觉模拟量表上的个体最大值。

结果

40 名参与者被随机分配，其中 34 名可评估药效学结果。在药物喜欢视觉模拟量表最大值的个体内头对头比较中，两种剂量的 Silexan 被评为与安慰剂相似，而在 Silexan 和劳拉西泮之间以及安慰剂和劳拉西泮之间观察到差异（P  < .001）。这些数据得到了积极药物效应和效应平衡的所有二级测量的支持。安慰剂和两种剂量的 Silexan 之间的差异总是可以忽略不计。此外，Silexan 没有显示出镇静作用，并且被认为与参与者过去使用的常用药物不相似。

结论

Silexan 在标准滥用潜力检测筛选研究中没有表现出任何滥用潜力，并且不太可能被娱乐性滥用。