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托吡酯治疗苯丙胺和甲基苯丙胺使用障碍的有效性:一项随机对照试验。

The Effectiveness of Topiramate in the Treatment of Amphetamine and Methamphetamine Use Disorder: A Randomized Controlled Trial.

作者信息

Moghaddam Sadegh Amirali, Nazarinasab Masoumeh, Behrouzian Forouzan, Rostami Hamzeh, Mehrabi Masoumeh

机构信息

Department of Psychiatry, School of Medicine, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

出版信息

Iran J Psychiatry. 2023 Oct;18(4):371-379. doi: 10.18502/ijps.v18i4.13624.

Abstract

Limited studies have yet evaluated the effectiveness of topiramate in the treatment of amphetamine and methamphetamine addiction. Therefore, the aim of this study was to investigate the effectiveness of topiramate in the treatment of patients with this disorder. In this randomized, double-blind, placebo-controlled clinical trial, 52 patients with amphetamine and methamphetamine use disorder, within the age range of 16-60 years, were randomly divided into an intervention group (n = 26) and a placebo group (n = 26). The intervention group was treated with topiramate tablets with a starting dose of 50 mg, which was gradually increased to the target dose of 200 mg. The control group was treated with placebo. The duration of drug intervention in this clinical trial was 12 weeks, and all participants were evaluated before the intervention and 2, 4, 6, 8, 10, and 12 weeks after beginning the intervention. The Beck Depression Inventory, drug use temptation questionnaire, urine test, and side effects questionnaire were used as outcome measures to assess the patients. The data were analyzed using chi-square, independent t-test, and analysis of variance with repeated measurements. There was no significant difference between the intervention and placebo groups in depression at the beginning of the treatment and at the 4, 8, and 12 weeks after the intervention (P > 0.05). The urine test also showed no significant difference between the two groups at any of the evaluation stages (P > 0.05). Although there was no significant difference between the two groups in the drug use temptation results at the beginning and the 2, 4 and 6 weeks (P > 0.05), the level of drug temptation in the intervention group was significantly lower than the placebo group in the 8, 10, and 12 weeks (P < 0.05). Topiramate can be effective in reducing the desire to use amphetamine and methamphetamine. However, further studies are needed to confirm these results.

摘要

仅有有限的研究评估了托吡酯在治疗苯丙胺和甲基苯丙胺成瘾方面的有效性。因此,本研究的目的是调查托吡酯在治疗患有这种疾病的患者中的有效性。在这项随机、双盲、安慰剂对照的临床试验中,52名年龄在16至60岁之间的苯丙胺和甲基苯丙胺使用障碍患者被随机分为干预组(n = 26)和安慰剂组(n = 26)。干预组接受托吡酯片治疗,起始剂量为50毫克,逐渐增加至目标剂量200毫克。对照组接受安慰剂治疗。该临床试验的药物干预持续时间为12周,所有参与者在干预前以及开始干预后的2、4、6、8、10和12周进行评估。使用贝克抑郁量表、药物使用诱惑问卷、尿液检测和副作用问卷作为评估患者的结局指标。数据采用卡方检验、独立t检验和重复测量方差分析进行分析。在治疗开始时以及干预后的4、8和12周,干预组和安慰剂组在抑郁方面没有显著差异(P > 0.05)。尿液检测在任何评估阶段两组之间也没有显著差异(P > 0.05)。虽然两组在开始时以及2、4和6周的药物使用诱惑结果没有显著差异(P > 0.05),但在8、10和12周时,干预组的药物诱惑水平显著低于安慰剂组(P < 0.05)。托吡酯在降低使用苯丙胺和甲基苯丙胺的欲望方面可能有效。然而,需要进一步的研究来证实这些结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a313/10594000/1407d1a1dfec/IJPS-18-371-g001.jpg

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