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按需鼻内使用纳洛酮治疗赌博障碍:一项随机对照试验。

Intranasal as needed naloxone in the treatment of gambling disorder: A randomised controlled trial.

作者信息

Alho Hannu, Mäkelä Niklas, Isotalo Jarkko, Toivonen Lilianne, Ollikainen Jyrki, Castrén Sari

机构信息

University of Helsinki, Department of Medicine, Helsinki, Finland; Finnish Institute for Health and Welfare, Health and Well-Being Promotion Unit, Finland.

University of Helsinki, Department of Medicine, Helsinki, Finland.

出版信息

Addict Behav. 2022 Feb;125:107127. doi: 10.1016/j.addbeh.2021.107127. Epub 2021 Sep 30.

Abstract

BACKGROUND

Gambling disorder (GD) is a global phenomenon affecting millions of people. GD can result in severe social and financial difficulties and efficacious treatments are warranted. Psychosocial treatments form the basis of treatment. Opioid antagonists (OAs) have however shown promise in previous studies. In a recent imaging study intranasal naloxone was found to rapidly and fully occupy brain μ-opioid receptors. This trial investigates the effect and safety of as needed naloxone in the treatment of gambling disorder.

METHODS

This was a 12-week double blind, randomised control trial comparing intranasal naloxone to placebo. The primary endpoint was gambling urge measured by the Gambling symptom Assessment Scale (G-SAS). Secondary outcome measures were gambling severity measures (PGSI) as well as quality of life (WHO:EUROHIS-8), alcohol consumption (AUDIT), depression (MARDS) and internet use (IDS-9SF). In addition, safety of treatment was assessed. Both treatment groups received psychosocial support.

RESULTS

126 participants were randomised to treatment groups in a 1:1 ratio. 106 patients completed the study. Gambling urge (GSAS) and other gambling related measured improved in both groups, but no statistically significant difference could be found. Intranasal naloxone was well tolerated, no subjects discontinued the study due to adverse events. No serious adverse drug reactions were observed.

CONCLUSIONS

This study found no difference between the as-needed administration of intranasal naloxone and placebo in reducing gambling urge in persons with GD. Intranasal naloxone was safe and well tolerated.

摘要

背景

赌博障碍(GD)是一种影响数百万人的全球现象。GD会导致严重的社会和经济困难,因此需要有效的治疗方法。心理社会治疗是治疗的基础。然而,阿片类拮抗剂(OAs)在先前的研究中已显示出前景。在最近的一项影像学研究中,发现鼻内纳洛酮能迅速且完全占据大脑μ-阿片受体。本试验研究按需使用纳洛酮治疗赌博障碍的效果和安全性。

方法

这是一项为期12周的双盲随机对照试验,将鼻内纳洛酮与安慰剂进行比较。主要终点是通过赌博症状评估量表(G-SAS)测量的赌博冲动。次要结局指标包括赌博严重程度指标(PGSI)以及生活质量(世界卫生组织:欧洲健康状况调查问卷-8)、酒精消费(酒精使用障碍识别测试)、抑郁(蒙哥马利-阿斯伯格抑郁量表)和互联网使用(互联网成瘾诊断量表-9项简版)。此外,评估了治疗的安全性。两个治疗组均接受心理社会支持。

结果

126名参与者按1:1的比例随机分配到治疗组。106名患者完成了研究。两组的赌博冲动(G-SAS)和其他与赌博相关的测量指标均有所改善,但未发现统计学上的显著差异。鼻内纳洛酮耐受性良好,没有受试者因不良事件而中断研究。未观察到严重的药物不良反应。

结论

本研究发现,按需使用鼻内纳洛酮与安慰剂在降低GD患者的赌博冲动方面没有差异。鼻内纳洛酮安全且耐受性良好。

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